An interventional study of CardioMEMS™ HF System in Heart Failure, Heart Failure, Systolic and Heart Failure, Diastolic, sponsored by Abbott Medical Devices. Completed at 129 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-07.
Sponsored by Abbott Medical Devices (part of Abbott) · Not applicable, Interventional, and Treatment
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Among 120 studies in Heart Failure by Abbott — 6 open to participants now, 9 under way, none of them phase 3. Heart Failure · Abbott.
Among the 120 studies in Heart Failure by Abbott, this one is the 2nd largest by enrollment of the 72 interventional ones that give a count, is one of 4 that started in 2018, is one of 62 with no phase, and was the 99th registered.
6,332 studies on the registry are indexed under Heart Failure; 1,392 are open to participants now.
Browse Heart Failure studies →6 of the 120 studies in Heart Failure by Abbott are open now, in 12 countries. Recruiting first, the newest first:
Abbott Medical Devices · Sites in Brazil, France, Germany and 6 more countries
Ages 18+
Abbott Medical Devices · Sites in United States
Ages 18+
Abbott Medical Devices · Sites in United States, Austria, Czechia and 5 more countries
Ages 18+
Abbott Medical Devices · Sites in Italy
Ages 18+
Abbott Medical Devices · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 966 Heart Failure studies recruiting now, 689 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 63 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
120 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 2 · Phase 3 4 · Phase 4 5
First in 2002; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 2,358 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Median enrollment 136 across the 72 interventional studies, 154 across the 45 observational. Of the 106 that completed or were terminated, 53 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Abbott Medical Devices, one of the names counted as Abbott. Under that name alone:
Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
3 of the studies in Heart Failure by Abbott that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06436053Abbott Medical DevicesAcute Response to Left Bundle Branch Area Pacing With SyncAV | 2026-12-15 |
| NCT07877805Abbott Medical DevicesMerlin Expanded ECG NSR | 2027-01 |
| NCT07217392Abbott Medical DevicesLeft Bundle Branch Area Pacing (LBBAP) PMCF Study | 2027-04-30 |
Add all 3 to your calendar (.ics) → With an account.
Among the 120 studies in Heart Failure by Abbott, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including HF patients outside of the present indication, but at risk for future HF events or mortality.
The trial includes patients with New York Heart Association (NYHA) Class II, III, or IV HF who have an elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or an elevated Brain Natriuretic Peptide (BNP)) and/or a prior HF hospitalization (HFH).
The GUIDE-HF IDE trial will include approximately 3600 subjects at approximately 140 North American sites and consists of two arms: a Randomized Arm and a Single Arm.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis and treatment for heart failure (HF) (regardless of (LVEF)) for > 90 days prior to the date of consent:
a. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United States, with any intolerance documented.
HF hospitalization (HFH) within 12 months prior to consent and/or elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or Brain Natriuretic Peptide (BNP)) within 30 days prior to consent defined as:
Exclusion Criteria:
Class IV HF patients with:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.
Device: CardioMEMS™ HF System
Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.
Device: CardioMEMS™ HF System
Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.
Device: CardioMEMS™ HF System
The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.
Also known as: CardioMEMS, CardioMEMS PA Sensor, CardioMEMS HF System
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality
The composite of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP) 3. The number of deaths of any cause added together with equal weighting into a total number of events
Time frame: 12 months post-implantation (395 days after implant date)
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]
The composite of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP) 3. The number of deaths of any cause added together with equal weighting into a total number of events.
Time frame: The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]
The composite of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP) 3. The number of deaths of any cause added together with equal weighting into a total number of events.
Time frame: 12 Months Post Implantation
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]
The composite of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP) 3. The number of deaths of any cause added together with equal weighting into a total number of events.
Time frame: 12 Months Post-Implantation
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality
The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy 3. The number of deaths of any cause added together with equal weighting into a total number of events
Time frame: 12 months post-implantation (395 days after implant date)
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]
The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy 3. The number of deaths of any cause added together with equal weighting into a total number of events
Time frame: Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]
The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy 3. The number of deaths of any cause added together with equal weighting into a total number of events
Time frame: 12 Months Post Implantation
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]
The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy 3. The number of deaths of any cause added together with equal weighting into a total number of events
Time frame: 12 Months Post Implantation
(Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits
The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy added together with equal weighting into a total number of events
Time frame: 12 months post-implantation
(Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis)
The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy added together with equal weighting into a total number of events
Time frame: The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).
(Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis)
The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy added together with equal weighting into a total number of events
Time frame: 12 Months Post Implantation
(Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis)
The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy added together with equal weighting into a total number of events
Time frame: 12 Months Post Implantation
(Randomized Arm) HFHs
The number of recurrent HFHs
Time frame: 12 months post-implantation
(Randomized Arm) HFHs [Follow-up Based COVID-19 Sensitivity Analysis]
The number of recurrent HFHs
Time frame: The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).
(Randomized Arm) HFHs [Subject Based COVID-19 Sensitivity Analysis]
The number of recurrent HFHs
Time frame: 12 Months Post-Implantation
(Randomized Arm) HFHs [Event Based COVID-19 Sensitivity Analysis]
The number of recurrent HFHs
Time frame: 12 Months Post Implantation
(Randomized Arm) Intravenous Diuretic Visits
The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
Time frame: 12 months post-implantation
(Randomized Arm) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis]
The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
Time frame: The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).
(Randomized Arm) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis]
The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
Time frame: 12 Months Post Implantation
(Randomized Arm) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis]
The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
Time frame: 12 Months Post-Implantation
(Randomized Arm) All-cause Mortality
The number of deaths of any cause
Time frame: 12 months post-implantation
(Randomized Arm) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]
The number of deaths of any cause
Time frame: The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).
(Randomized Arm) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]
The number of deaths of any cause
Time frame: 12 Months Post-Implantation
(Randomized Arm) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]
The number of deaths of any cause
Time frame: 12 Months Post-Implantation
(Randomized Arm) KCCQ-12
Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life over a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status. Change from baseline KCCQ-12 scores were evaluated at 6 and 12-month visits.
Time frame: Baseline, 6, and 12 months post-implantation
(Randomized Arm) KCCQ-12 (Subject Based COVID-19 Sensitivity Analysis)
Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life over a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status. Descriptive statistics of KCCQ-12 scores at baseline, 6 and 12-month visits were reported.
Time frame: Baseline, 6, and 12 months post-implantation
(Randomized Arm) EQ-5D-5L
Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire The EQ-5D-5L Questionnaire is a standardized measure of health status that consists of a descriptive system and a visual analog score (VAS). The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score represents a better quality of life.
Time frame: Baseline, 6, and 12 months post-implantation
(Randomized Arm) EQ-5D-5L (Subject Based COVID-19 Sensitivity Analysis)
Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire The EQ-5D-5L Questionnaire is a standardized measure of health status that consists of a descriptive system and a visual analog score (VAS). The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score represents a better quality of life.
Time frame: Baseline, 6, and 12 months post-implantation
(Randomized Arm) 6MHW Test
Six Minute Hall Walk (6MHW) Test Distance
Time frame: Baseline, 6, and 12 months post-implantation
(Randomized Arm) 6MHW Test (Subject Based COVID-19 Sensitivity Analysis)
Six Minute Hall Walk (6MHW) Test Distance
Time frame: Baseline, 6, and 12 months post-implantation
(Randomized Arm) Safety: Freedom From DSRCs
Freedom from device/system related complications (DSRCs)
Time frame: 12 months post-implantation
(Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits
The composite outcome of: 1. The number of recurrent HFHs 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy added together with equal weighting into a total number of events
Time frame: 12 months post-implantation
(Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis]
The composite outcome of: 1. The number of recurrent HFHs 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy added together with equal weighting into a total number of events
Time frame: Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).
(Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis]
The composite outcome of: 1. The number of recurrent HFHs 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy added together with equal weighting into a total number of events
Time frame: 12 Months Post Implantation
(Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis]
The composite outcome of: 1. The number of recurrent HFHs 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy added together with equal weighting into a total number of events
Time frame: 12 Months Post Implantation
(Single Arm) Intravenous Diuretic Visits
The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy
Time frame: 12 months post-implantation
(Single Arm) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis]
The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy
Time frame: Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).
(Single Arm) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis]
The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy
Time frame: 12 months post-implantation
(Single Arm) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis]
The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy
Time frame: 12 Months Post Implantation
(Single Arm) HFHs
The number of HFHs
Time frame: 12 months post-implantation
(Single Arm) HFHs [Follow-Up Based COVID-19 Sensitivity Analysis]
The number of heart failure hospitalizations (HFHs)
Time frame: Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).
(Single Arm) HFHs [Subject Based COVID-19 Sensitivity Analysis]
The number of heart failure hospitalizations (HFHs)
Time frame: 12 Months Post Implantation
(Single Arm) HFHs [Event Based COVID-19 Sensitivity Analysis]
The number of heart failure hospitalizations (HFHs)
Time frame: 12 Months Post Implantation
(Single Arm) All-cause Mortality
The number of deaths of any cause
Time frame: 12 months post-implantation
(Single Arm) All-cause Mortality [Follow-Up Based COVID-19 Sensitivity Analysis]
The number of deaths of any cause
Time frame: Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).
(Single Arm) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]
The number of deaths of any cause
Time frame: 12 Months Post Implantation
(Single Arm) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]
The number of deaths of any cause
Time frame: 12 Months Post Implantation
(Single Arm) Safety: Freedom From DSRCs
Proportion of subjects with freedom from device/system related complications (DSRCs)
Time frame: 12 months post-implantation
(Single Arm) HFHs Post- vs. Pre-implantation [Elevated NT-proBNP/BNP Only Group]
The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation
Time frame: 12 months post-implantation vs 12 months pre-implantation
(Single Arm) HFHs Post- vs. Pre-implantation [Previous HF Hospitalization Only Group]
The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation
Time frame: 12 months post-implantation vs 12 months pre-implantation
(Single Arm) HFHs Post- vs. Pre-implantation [Elevated NT-proBNP/BNP and Previous HF Hospitalization Group]
The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation
Time frame: 12 months post-implantation vs 12 months pre-implantation
(Randomized Arm) Cardiovascular Mortality
The number of deaths with cardiovascular cause
Time frame: 12 months post-implantation
(Randomized Arm) All-cause Hospitalizations
The number of hospitalizations of any cause
Time frame: 12 months post-implantation
(Randomized Arm) Frequency of Subject PA Pressure Uploads
The frequency of subject uploads of PA pressure
Time frame: 12 months post-implantation
(Randomized Arm) HF Medication Changes
The number of changes in HF medications
Time frame: 12 months post-implantation
(Randomized Arm) PA Pressure Measurements [Mixed Model Analysis]
Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using a mixed linear model at fixed time points (Baseline, 6 months, and 12 months) producing least-squares means.
Time frame: Baseline through 12 months post-implantation
(Randomized Arm) PA Pressure Measurements [AUC Analysis]
Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using an area under the curve (AUC) analysis of change from baseline on all PA pressure readings through 12 months.
Time frame: Baseline through 12 months post-implantation
(Randomized Arm) BNP
Change in BNP measurements from baseline
Time frame: 6 months post-implantation
(Randomized Arm) BNP
Change in BNP measurements from baseline
Time frame: 12 months post-implantation
(Randomized Arm) NT-proBNP
Change in NT-proBNP measurements from baseline
Time frame: 6 months post-implantation
(Randomized Arm) NT-proBNP
Change in NT-proBNP measurements from baseline
Time frame: 12 months post-implantation
(Randomized Arm) HFHs Post- vs. Pre-implantation [Treatment Group]
The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation in the Treatment group
Time frame: 12 months post-implantation vs 12 months pre-implantation
(Randomized Arm) HFHs Post- vs. Pre-implantation [Control Group]
The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation
Time frame: 12 months post-implantation vs 12 months pre-implantation
(Single Arm) KCCQ-12 [Mixed Model Analysis]
Health status as assessed by the KCCQ-12 The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life on a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status.
Time frame: 6 months post-implantation
(Single Arm) KCCQ-12 [Mixed Model Analysis]
Health status as assessed by the KCCQ-12 The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life on a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status.
Time frame: 12 months post-implantation
(Single Arm) EQ-5D-5L [Mixed Model Analysis]
Health status as assessed by the EQ-5D-5L Questionnaire. The data represents the EQ Visual Analogue Scale (VAS) subscale. The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score for represents a better quality of life.
Time frame: 6 months post-implantation
(Single Arm) EQ-5D-5L [Mixed Model Analysis]
Health status as assessed by the EQ-5D-5L Questionnaire. The data represents the EQ Visual Analogue Scale (VAS) subscale. The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score for represents a better quality of life.
Time frame: 12 months post-implantation
(Single Arm) 6MHW Test [Mixed Model Analysis]
6MHW Test Distance
Time frame: 6 months post-implantation
(Single Arm) 6MHW Test [Mixed Model Analysis]
6MHW Test Distance
Time frame: 12 months post-implantation
(Single Arm) Cardiovascular Mortality
The number of deaths of cardiovascular cause
Time frame: 12 months post-implantation
(Single Arm) All-cause Hospitalizations
The number of hospitalizations of any cause
Time frame: 12 months post-implantation
(Single Arm) Frequency of Subject PA Pressure Uploads - Daily Compliance
The frequency of subject uploads of PA pressure
Time frame: 12 months post-implantation
(Single Arm) Frequency of Subject PA Pressure Uploads - Weekly Compliance
The frequency of subject uploads of PA pressure
Time frame: 12 months post-implantation
(Single Arm) HF Medication Changes
The number of changes in HF medications
Time frame: 12 months post-implantation
(Single Arm) PA Pressure Measurements [Mixed Model Analysis]
Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using a mixed linear model at fixed time points (Baseline, 6 months, and 12 months) producing least-squares means.
Time frame: Baseline through 12 months post-implantation
(Single Arm) PA Pressure Measurements [AUC Analysis]
Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using area under the curve (AUC) analysis of PA pressure across the full follow-up period
Time frame: Baseline through 12 months post-implantation
(Single Arm) NT-proBNP (or BNP) [Mixed Model Analysis]
Either change in N-terminal pro-brain natriuretic peptide (NT-proBNP) or Brain natriuretic peptide (BNP) measurements at 6 months visits from baseline.
Time frame: 6 months post-implantation
(Single Arm) NT-proBNP (or BNP) [Mixed Model Analysis]
Either change in N-terminal pro-brain natriuretic peptide (NT-proBNP) or Brain natriuretic peptide (BNP) measurements at 6 months and 12 months visits from baseline.
Time frame: 12 months post-implantation
Randomized Arm enrolled 1022 subjects across 118 sites, of which 1000 are endpoint-contributing (successfully implanted and randomized). Subject enrollment took place between March 2018 and December 2019, with the last follow-up completed in January 2021. Single Arm enrolled 1401 subjects across 119 sites, of which 1358 are endpoint-contributing (successfully implanted). Subject enrollment took place between March 2018 and April 2022, with the last follow-up completed in May 2023.
| Milestone | Randomized Arm - Treatment Group | Randomized Arm - Control Group | Single Arm |
|---|---|---|---|
| Started | 497 | 503 | 1358 |
| Complete 6 month follow-up | 467 | 469 | 1238 |
| Completed | 432 | 422 | 1076 |
| Not completed | 65 | 81 | 282 |
| Withdrew: Death | 40 | 37 | 190 |
| Withdrew: Withdrawal by subject | 9 | 19 | 32 |
| Withdrew: Lost to follow-up | 3 | 9 | 15 |
| Withdrew: Non-compliance | 6 | 6 | 31 |
| Withdrew: Subject in hospice/relocated/severe covid-19/on transplant list/pi discretion | 7 | 10 | 14 |
The composite of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP) 3. The number of deaths of any cause added together with equal weighting into a total number of events
| events per patient-year | Randomized Arm - Treatment Group | Randomized Arm - Control Group |
|---|---|---|
| (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality | 0.563 | 0.640 |
The composite of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP) 3. The number of deaths of any cause added together with equal weighting into a total number of events.
| events per patient-year | Randomized Arm - Treatment Group [Pre-COVID-19] | Randomized Arm - Control Group [Pre-COVID-19] | Randomized Arm - Treatment Group [During COVID-19] | Randomized Arm - Control Group [During COVID-19] |
|---|---|---|---|---|
| (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis] | 0.553 | 0.682 | 0.597 | 0.536 |
The composite of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP) 3. The number of deaths of any cause added together with equal weighting into a total number of events.
| events per patient-year | Randomized Arm - Treatment Group (Pre-COVID-19) | Randomized Arm - Control Group (Pre-COVID-19) | Randomized Arm - Treatment Group (During COVID-19) | Randomized Arm - Control Arm (During COVID-19) |
|---|---|---|---|---|
| (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis] | 0.710 | 0.864 | 0.508 | 0.539 |
The composite of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP) 3. The number of deaths of any cause added together with equal weighting into a total number of events.
| events per patient-year | Randomized Arm - Treatment Group [Excluding COVID-19 Related Events] | Randomized Arm - Control Group [Excluding COVID-19 Related Events] | Randomized Arm - Treatment Group [Excluding COVID-19 Related or Possibly Related Events] | Randomized Arm - Control Group [Excluding COVID-19 Related or Possibly Related Events] |
|---|---|---|---|---|
| (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis] | 0.563 | 0.633 | 0.558 | 0.619 |
The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy 3. The number of deaths of any cause added together with equal weighting into a total number of events
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only | Single Arm - Previous HF Hospitalization Only |
|---|---|---|
| (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality | 0.394 | 0.771 |
The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy 3. The number of deaths of any cause added together with equal weighting into a total number of events
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only [Prior to COVID-19] | Single Arm - Previous HF Hospitalization Only [Prior to COVID-19] | Single Arm - Elevated NT-proBNP/BNP Only [During COVID-19] | Single Arm - Previous HF Hospitalization Only [During COVID-19] |
|---|---|---|---|---|
| (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis] | 0.263 | 0.861 | 0.418 | 0.744 |
The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy 3. The number of deaths of any cause added together with equal weighting into a total number of events
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only (Pre-COVID-19) | Single Arm - Previous HF Hospitalization Only (Pre-COVID-19) | Single Arm - Elevated NT-proBNP/BNP Only (During COVID-19) | Single Arm - Previous HF Hospitalization Only (During COVID-19) |
|---|---|---|---|---|
| (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis] | 0.582 | 1.853 | 0.391 | 0.698 |
The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy 3. The number of deaths of any cause added together with equal weighting into a total number of events
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only [Exclude COVID-19 Related Events] | Single Arm - Previous HF Hospitalization Only [Exclude COVID-19 Related Events] | Single Arm - Elevated NT-proBNP/BNP Only [Exclude COVID-19 Related or Possibly Related Events] | Single Arm - Previous HF Hospitalization Only [Exclude COVID-19 Related or Possibly Related Events] |
|---|---|---|---|---|
| (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis] | 0.381 | 0.746 | 0.377 | 0.737 |
The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy added together with equal weighting into a total number of events
| events per patient-year | Randomized Arm - Treatment Group | Randomized Arm - Control Group |
|---|---|---|
| (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits | 0.474 | 0.557 |
The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy added together with equal weighting into a total number of events
| events per patient-year | Randomized Arm - Treatment Group [Pre-COVID-19] | Randomized Arm - Control Group [Pre-COVID-19] | Randomized Arm - Treatment Group [During COVID-19] | Randomized Arm - Control Group [During COVID-19] |
|---|---|---|---|---|
| (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis) | 0.450 | 0.595 | 0.539 | 0.455 |
The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy added together with equal weighting into a total number of events
| events per patient-year | Randomized Arm - Treatment Group (Pre-COVID-19) | Randomized Arm - Control Group (Pre-COVID-19) | Randomized Arm - Treatment Group (During COVID-19) | Randomized Arm - Control Arm (During COVID-19) |
|---|---|---|---|---|
| (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis) | 0.529 | 0.729 | 0.465 | 0.488 |
The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy added together with equal weighting into a total number of events
| events per patient-year | Randomized Arm - Treatment Group [Excluding COVID-19 Related Events] | Randomized Arm - Control Group [Excluding COVID-19 Related Events] | Randomized Arm - Treatment Group [Excluding COVID-19 Related or Possibly Related Events] | Randomized Arm - Control Group [Excluding COVID-19 Related or Possibly Related Events] |
|---|---|---|---|---|
| (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis) | 0.474 | 0.551 | 0.472 | 0.545 |
The number of recurrent HFHs
| events per patient-year | Randomized Arm - Treatment Group | Randomized Arm - Control Group |
|---|---|---|
| (Randomized Arm) HFHs | 0.410 | 0.497 |
The number of recurrent HFHs
| events per patient-year | Randomized Arm - Treatment Group [Pre-COVID] | Randomized Arm - Control Group [Pre-COVID] | Randomized Arm - Treatment Group [During COVID-19] | Randomized Arm - Control Group [During COVID-19] |
|---|---|---|---|---|
| (Randomized Arm) HFHs [Follow-up Based COVID-19 Sensitivity Analysis] | 0.380 | 0.525 | 0.490 | 0.414 |
The number of recurrent HFHs
| events per patient-year | Randomized Arm - Treatment Group (Pre-COVID-19) | Randomized Arm - Control Group (Pre-COVID-19) | Randomized Arm - Treatment Group (During COVID-19) | Randomized Arm - Control Arm (During COVID-19) |
|---|---|---|---|---|
| (Randomized Arm) HFHs [Subject Based COVID-19 Sensitivity Analysis] | 0.467 | 0.666 | 0.399 | 0.428 |
The number of recurrent HFHs
| events per patient-year | Randomized Arm - Treatment Group [Excluding COVID-19 Related Events] | Randomized Arm - Control Group [Excluding COVID-19 Related Events] | Randomized Arm - Treatment Group [Excluding COVID-19 Related or Possibly Related Events] | Randomized Arm - Control Group [Excluding COVID-19 Related or Possibly Related Events] |
|---|---|---|---|---|
| (Randomized Arm) HFHs [Event Based COVID-19 Sensitivity Analysis] | 0.411 | 0.490 | 0.409 | 0.484 |
The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
| events per patient-year | Randomized Arm - Treatment Group | Randomized Arm - Control Group |
|---|---|---|
| (Randomized Arm) Intravenous Diuretic Visits | 0.065 | 0.063 |
The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
| events per patient-year | Randomized Arm - Treatment Group [Pre-COVID] | Randomized Arm - Control Group [Pre-COVID] | Randomized Arm - Treatment Group [During COVID-19] | Randomized Arm - Control Group [During COVID-19] |
|---|---|---|---|---|
| (Randomized Arm) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis] | 0.074 | 0.073 | 0.048 | 0.041 |
The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
| events per patient-year | Randomized Arm - Treatment Group (Pre-COVID-19) | Randomized Arm - Control Group (Pre-COVID-19) | Randomized Arm - Treatment Group (During COVID-19) | Randomized Arm - Control Arm (During COVID-19) |
|---|---|---|---|---|
| (Randomized Arm) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis] | 0.067 | 0.071 | 0.067 | 0.060 |
The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
| events per patient-year | Randomized Arm - Treatment Group [Excluding COVID-19 Related Events] | Randomized Arm - Control Group [Excluding COVID-19 Related Events] | Randomized Arm - Treatment Group [Excluding COVID-19 Related or Possibly Related Events] | Randomized Arm - Control Group [Excluding COVID-19 Related or Possibly Related Events] |
|---|---|---|---|---|
| (Randomized Arm) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis] | 0.065 | 0.063 | 0.065 | 0.063 |
The number of deaths of any cause
| events per patient-year | Randomized Arm - Treatment Group | Randomized Arm - Control Group |
|---|---|---|
| (Randomized Arm) All-cause Mortality | 0.094 | 0.086 |
The number of deaths of any cause
| events per patient-year | Randomized Arm - Treatment Group [Pre-COVID] | Randomized Arm - Control Group [Pre-COVID] | Randomized Arm - Treatment Group [During COVID-19] | Randomized Arm - Control Group [During COVID-19] |
|---|---|---|---|---|
| (Randomized Arm) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis] | 0.110 | 0.088 | 0.067 | 0.085 |
The number of deaths of any cause
| events per patient-year | Randomized Arm - Treatment Group (Pre-COVID-19) | Randomized Arm - Control Group (Pre-COVID-19) | Randomized Arm - Treatment Group (During COVID-19) | Randomized Arm - Control Arm (During COVID-19) |
|---|---|---|---|---|
| (Randomized Arm) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis] | 0.200 | 0.161 | 0.044 | 0.053 |
The number of deaths of any cause
| events per patient-year | Randomized Arm - Treatment Group [Excluding COVID-19 Related Events] | Randomized Arm - Control Group [Excluding COVID-19 Related Events] | Randomized Arm - Treatment Group [Excluding COVID-19 Related or Possibly Related Events] | Randomized Arm - Control Group [Excluding COVID-19 Related or Possibly Related Events] |
|---|---|---|---|---|
| (Randomized Arm) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis] | 0.094 | 0.086 | 0.090 | 0.079 |
Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life over a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status. Change from baseline KCCQ-12 scores were evaluated at 6 and 12-month visits.
| scores on a scale | Randomized Arm - Treatment Group (6 Month) | Randomized Arm - Control Group (6 Month) | Randomized Arm - Treatment Group (12 Month) | Randomized Arm - Control Group (12 Month) |
|---|---|---|---|---|
| (Randomized Arm) KCCQ-12 | 7.36 ± 1.01 | 6.01 ± 1.02 | 4.77 ± 1.03 | 4.14 ± 1.05 |
Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life over a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status. Descriptive statistics of KCCQ-12 scores at baseline, 6 and 12-month visits were reported.
| scores on a scale | Randomized Arm - Treatment Group (Baseline) [Pre-COVID-19] | Randomized Arm - Control Group (Baseline) [Pre-COVID-19] | Randomized Arm - Treatment Group (6 Month) [Pre-COVID-19] | Randomized Arm - Control Group (6 Month) [Pre-COVID-19] | Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] | Randomized Arm - Control Group (12 Month) [Pre-COVID-19] | Randomized Arm - Treatment Group (Baseline) [During COVID-19] | Randomized Arm - Control Group (Baseline) [During COVID-19] | Randomized Arm - Treatment Group (6 Month) [During COVID-19] | Randomized Arm - Control Group (6 Month) [During COVID-19] | Randomized Arm - Treatment Group (12 Month) [During COVID-19] | Randomized Arm - Control Group (12 Month) [During COVID-19] |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (Randomized Arm) KCCQ-12 (Subject Based COVID-19 Sensitivity Analysis) | 54.8 ± 25.4 | 56.4 ± 23.9 | 65.1 ± 24.3 | 63.6 ± 24.6 | 62.0 ± 24.0 | 62.9 ± 22.2 | 55.0 ± 23.6 | 53.9 ± 23.6 | 62.5 ± 24.3 | 60.3 ± 24.7 | 61.3 ± 24.7 | 58.2 ± 24.7 |
Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire The EQ-5D-5L Questionnaire is a standardized measure of health status that consists of a descriptive system and a visual analog score (VAS). The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score represents a better quality of life.
| scores on a scale | Randomized Arm - Treatment Group (6 Month) | Randomized Arm - Control Group (6 Month) | Randomized Arm - Treatment Group (12 Month) | Randomized Arm - Control Group (12 Month) |
|---|---|---|---|---|
| (Randomized Arm) EQ-5D-5L | 3.18 ± 0.97 | 3.20 ± 0.97 | 1.02 ± 0.99 | 2.50 ± 1.00 |
Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire The EQ-5D-5L Questionnaire is a standardized measure of health status that consists of a descriptive system and a visual analog score (VAS). The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score represents a better quality of life.
| scores on a scale | Randomized Arm - Treatment Group (Baseline) [Pre-COVID-19] | Randomized Arm - Control Group (Baseline) [Pre-COVID-19] | Randomized Arm - Treatment Group (6 Month) [Pre-COVID-19] | Randomized Arm - Control Group (6 Month) [Pre-COVID-19] | Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] | Randomized Arm - Control Group (12 Month) [Pre-COVID-19] | Randomized Arm - Treatment Group (Baseline) [During COVID-19] | Randomized Arm - Control Group (Baseline) [During COVID-19] | Randomized Arm - Treatment Group (6 Month) [During COVID-19] | Randomized Arm - Control Group (6 Month) [During COVID-19] | Randomized Arm - Treatment Group (12 Month) [During COVID-19] | Randomized Arm - Control Group (12 Month) [During COVID-19] |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (Randomized Arm) EQ-5D-5L (Subject Based COVID-19 Sensitivity Analysis) | 66.5 ± 20.3 | 67.3 ± 18.9 | 71.7 ± 18.3 | 71.2 ± 20.0 | 68.3 ± 20.9 | 71.5 ± 18.5 | 66.2 ± 18.1 | 63.4 ± 19.7 | 69.5 ± 19.2 | 67.1 ± 20.6 | 68.8 ± 19.8 | 66.4 ± 21.9 |
Six Minute Hall Walk (6MHW) Test Distance
| meters, m | Randomized Arm - Treatment Group (6 Month) | Randomized Arm - Control Group (6 Month) | Randomized Arm - Treatment Group (12 Month) | Randomized Arm - Control Group (12 Month) |
|---|---|---|---|---|
| (Randomized Arm) 6MHW Test | -1.13 ± 5.25 | 3.01 ± 5.16 | -13.02 ± 5.54 | -10.09 ± 5.50 |
Six Minute Hall Walk (6MHW) Test Distance
| meters, m | Randomized Arm - Treatment Group (Baseline) [Pre-COVID-19] | Randomized Arm - Control Group (Baseline) [Pre-COVID-19] | Randomized Arm - Treatment Group (6 Month) [Pre-COVID-19] | Randomized Arm - Control Group (6 Month) [Pre-COVID-19] | Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] | Randomized Arm - Control Group (12 Month) [Pre-COVID-19] | Randomized Arm - Treatment Group (Baseline) [During COVID-19] | Randomized Arm - Control Group (Baseline) [During COVID-19] | Randomized Arm - Treatment Group (6 Month) [During COVID-19] | Randomized Arm - Control Group (6 Month) [During COVID-19] | Randomized Arm - Treatment Group (12 Month) [During COVID-19] | Randomized Arm - Control Group (12 Month) [During COVID-19] |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (Randomized Arm) 6MHW Test (Subject Based COVID-19 Sensitivity Analysis) | 227 ± 117.8 | 243.8 ± 124.7 | 239.3 ± 123.5 | 260.8 ± 120.8 | 230.4 ± 133.2 | 245.1 ± 136.1 | 240.2 ± 121.5 | 220.6 ± 121.3 | 249.8 ± 129.1 | 244.7 ± 135.6 | 246.0 ± 130.0 | 230.7 ± 135.3 |
Freedom from device/system related complications (DSRCs)
| Participants | Randomized Arm - Treatment Group | Randomized Arm - Control Group |
|---|---|---|
| (Randomized Arm) Safety: Freedom From DSRCs | 494 | 498 |
The composite outcome of: 1. The number of recurrent HFHs 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy added together with equal weighting into a total number of events
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only | Single Arm - Previous HF Hospitalization Only |
|---|---|---|
| (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits | 0.288 | 0.630 |
The composite outcome of: 1. The number of recurrent HFHs 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy added together with equal weighting into a total number of events
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only [Prior to COVID-19] | Single Arm - Previous HF Hospitalization Only [Prior to COVID-19] | Single Arm - Elevated NT-proBNP/BNP Only [During COVID-19] | Single Arm - Previous HF Hospitalization Only [During COVID-19] |
|---|---|---|---|---|
| (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis] | 0.211 | 0.677 | 0.303 | 0.616 |
The composite outcome of: 1. The number of recurrent HFHs 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy added together with equal weighting into a total number of events
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only (Pre-COVID-19) | Single Arm - Previous HF Hospitalization Only (Pre-COVID-19) | Single Arm - Elevated NT-proBNP/BNP Only (During COVID-19) | Single Arm - Previous HF Hospitalization Only (During COVID-19) |
|---|---|---|---|---|
| (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis] | 0.436 | 1.520 | 0.286 | 0.583 |
The composite outcome of: 1. The number of recurrent HFHs 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy added together with equal weighting into a total number of events
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only [Exclude COVID-19 Related Events] | Single Arm - Previous HF Hospitalization Only [Exclude COVID-19 Related Events] | Single Arm - Elevated NT-proBNP/BNP Only [Exclude COVID-19 Related or Possibly Related Events] | Single Arm - Previous HF Hospitalization Only [Exclude COVID-19 Related or Possibly Related Events] |
|---|---|---|---|---|
| (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis] | 0.282 | 0.624 | 0.277 | 0.617 |
The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only | Single Arm - Previous HF Hospitalization Only | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization |
|---|---|---|---|
| (Single Arm) Intravenous Diuretic Visits | 0.027 | 0.077 | 0.123 |
The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only [Prior to COVID-19] | Single Arm - Previous HF Hospitalization Only [Prior to COVID-19] | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [Prior to COVID-19] | Single Arm - Elevated NT-proBNP/BNP Only [During COVID-19] | Single Arm - Previous HF Hospitalization Only [During COVID-19] | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [During COVID-19] |
|---|---|---|---|---|---|---|
| (Single Arm) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis] | 0.055 | 0.064 | 0.199 | 0.024 | 0.088 | 0.114 |
The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only [Pre-COVID-19] | Single Arm - Previous HF Hospitalization Only [Pre-COVID-19] | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [Pre-COVID-19] | Single Arm - Elevated NT-proBNP/BNP Only [During COVID-19] | Single Arm - Previous HF Hospitalization Only [During COVID-19] | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [During COVID-19] |
|---|---|---|---|---|---|---|
| (Single Arm) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis] | 0.213 | 0.082 | 0.422 | 0.021 | 0.080 | 0.101 |
The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only [Exclude COVID Related Events] | Single Arm - Previous HF Hospitalization Only [Exclude COVID Related Events] | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [Exclude COVID Related Events] | Single Arm - Elevated NT-proBNP/BNP Only [Exclude COVID Related/Possibly Related Events] | Single Arm - Previous HF Hospitalization Only [Exclude COVID Related/Possibly Related Events] | Single Arm - Elevated NT-proBNP/BNP and Previous HFH [Exclude COVID Related/Possibly Related Events] |
|---|---|---|---|---|---|---|
| (Single Arm) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis] | 0.027 | 0.077 | 0.123 | 0.027 | 0.075 | 0.119 |
The number of HFHs
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only | Single Arm - Previous HF Hospitalization Only | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization |
|---|---|---|---|
| (Single Arm) HFHs | 0.263 | 0.557 | 0.797 |
The number of heart failure hospitalizations (HFHs)
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only [Prior to COVID-19] | Single Arm - Previous HF Hospitalization Only [Prior to COVID-19] | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [Prior to COVID-19] | Single Arm - Elevated NT-proBNP/BNP Only [During COVID-19] | Single Arm - Previous HF Hospitalization Only [During COVID-19] | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [During COVID-19] |
|---|---|---|---|---|---|---|
| (Single Arm) HFHs [Follow-Up Based COVID-19 Sensitivity Analysis] | 0.214 | 0.804 | 1.211 | 0.280 | 0.529 | 0.732 |
The number of heart failure hospitalizations (HFHs)
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only [Pre-COVID-19] | Single Arm - Previous HF Hospitalization Only [Pre-COVID-19] | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [Pre-COVID-19] | Single Arm - Elevated NT-proBNP/BNP Only [During COVID-19] | Single Arm - Previous HF Hospitalization Only [During COVID-19] | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [During COVID-19] |
|---|---|---|---|---|---|---|
| (Single Arm) HFHs [Subject Based COVID-19 Sensitivity Analysis] | 0.175 | 1.132 | 1.660 | 0.269 | 0.510 | 0.719 |
The number of heart failure hospitalizations (HFHs)
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only [Exclude COVID Related Events] | Single Arm - Previous HF Hospitalization Only [Exclude COVID Related Events] | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [Exclude COVID Related Events] | Single Arm - Elevated NT-proBNP/BNP Only [Exclude COVID Related/Possibly Related Events] | Single Arm - Previous HF Hospitalization Only [Exclude COVID Related/Possibly Related Events] | Single Arm - Elevated NT-proBNP/BNP and Previous HFH [Exclude COVID Related/Possibly Related Events] |
|---|---|---|---|---|---|---|
| (Single Arm) HFHs [Event Based COVID-19 Sensitivity Analysis] | 0.257 | 0.552 | 0.790 | 0.252 | 0.545 | 0.749 |
The number of deaths of any cause
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only | Single Arm - Previous HF Hospitalization Only | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization |
|---|---|---|---|
| (Single Arm) All-cause Mortality | 0.113 | 0.146 | 0.243 |
The number of deaths of any cause
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only [Prior to COVID-19] | Single Arm - Previous HF Hospitalization Only [Prior to COVID-19] | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [Prior to COVID-19] | Single Arm - Elevated NT-proBNP/BNP Only [During COVID-19] | Single Arm - Previous HF Hospitalization Only [During COVID-19] | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [During COVID-19] |
|---|---|---|---|---|---|---|
| (Single Arm) All-cause Mortality [Follow-Up Based COVID-19 Sensitivity Analysis] | 0.050 | 0.182 | 0.272 | 0.123 | 0.135 | 0.233 |
The number of deaths of any cause
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only [Pre-COVID-19] | Single Arm - Previous HF Hospitalization Only [Pre-COVID-19] | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [Pre-COVID-19] | Single Arm - Elevated NT-proBNP/BNP Only [During COVID-19] | Single Arm - Previous HF Hospitalization Only [During COVID-19] | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [During COVID-19] |
|---|---|---|---|---|---|---|
| (Single Arm) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis] | 0.147 | 0.384 | 0.583 | 0.113 | 0.120 | 0.202 |
The number of deaths of any cause
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only [Exclude COVID Related Events] | Single Arm - Previous HF Hospitalization Only [Exclude COVID Related Events] | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [Exclude COVID Related Events] | Single Arm - Elevated NT-proBNP/BNP Only [Exclude COVID Related/Possibly Related Events] | Single Arm - Previous HF Hospitalization Only [Exclude COVID Related/Possibly Related Events] | Single Arm - Elevated NT-proBNP/BNP and Previous HFH [Exclude COVID Related/Possibly Related Events] |
|---|---|---|---|---|---|---|
| (Single Arm) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis] | 0.105 | 0.125 | 0.231 | 0.105 | 0.123 | 0.227 |
Proportion of subjects with freedom from device/system related complications (DSRCs)
| Participants | Single Arm - Elevated NT-proBNP/BNP Only | Single Arm - Previous HF Hospitalization Only | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization |
|---|---|---|---|
| (Single Arm) Safety: Freedom From DSRCs | 451 | 548 | 342 |
The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only (One Year Prior to Implant) | Single Arm - Elevated NT-proBNP/BNP (One Year After Implant) |
|---|---|---|
| (Single Arm) HFHs Post- vs. Pre-implantation [Elevated NT-proBNP/BNP Only Group] | 0 | 0.265 |
The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation
| events per patient-year | Single Arm - Previous HF Hospitalization Only (One Year Prior to Implant) | Single Arm - Previous HF Hospitalization (One Year After Implant) |
|---|---|---|
| (Single Arm) HFHs Post- vs. Pre-implantation [Previous HF Hospitalization Only Group] | 1.170 | 0.540 |
The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation
| events per patient-year | Single Arm - Previous HF Hospitalization Only (One Year Prior to Implant) | Single Arm - Previous HF Hospitalization (One Year After Implant) |
|---|---|---|
| (Single Arm) HFHs Post- vs. Pre-implantation [Elevated NT-proBNP/BNP and Previous HF Hospitalization Group] | 1.380 | 0.874 |
The number of deaths with cardiovascular cause
| events per patient-year | Randomized Arm - Treatment Group | Randomized Arm - Control Group |
|---|---|---|
| (Randomized Arm) Cardiovascular Mortality | 0.071 | 0.057 |
The number of hospitalizations of any cause
| events per patient-year | Randomized Arm - Treatment Group | Randomized Arm - Control Group |
|---|---|---|
| (Randomized Arm) All-cause Hospitalizations | 0.918 | 0.973 |
The frequency of subject uploads of PA pressure
| Percentage | Randomized Arm - Treatment Group | Randomized Arm - Control Group |
|---|---|---|
| Daily compliance | 80.7 ± 20.4 | 73.8 ± 27.0 |
| Weekly compliance | 95.1 ± 13.7 | 89.1 ± 21.7 |
The number of changes in HF medications
| Number of medication changes | Randomized Arm - Treatment Group | Randomized Arm - Control Group |
|---|---|---|
| Angiotensin-Converting Enzyme (ACE) Inhibitors | 109 | 76 |
| Angiotensin Receptor Blocker (ARB) | 94 | 80 |
| Angiotensin Receptor-Neprilysin Inhibitor (ARNi) | 194 | 120 |
| Beta Blockers | 370 | 339 |
| Aldosterone Antagonists | 323 | 190 |
| Diuretics | 3961 | 2064 |
| Nitrates | 169 | 101 |
| Vasodilators | 146 | 83 |
| SGLT2 Inhibitor | 9 | 6 |
| Calcium Channel Blockers | 77 | 65 |
| Digoxin | 24 | 36 |
| Sinus Node If Channel Inhibitors | 12 | 4 |
Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using a mixed linear model at fixed time points (Baseline, 6 months, and 12 months) producing least-squares means.
| mmHg | Randomized Arm - Treatment Group (6 Month) | Randomized Arm - Control Group (6 Month) | Randomized Arm - Treatment Group (12 Month) | Randomized Arm - Control Group (12 Month) |
|---|---|---|---|---|
| PA Systolic Pressure | -3.41 ± 0.44 | -1.87 ± 0.46 | -3.33 ± 0.46 | -2.70 ± 0.47 |
| PA Diastolic pressure | -2.52 ± 0.27 | -1.73 ± 0.28 | -2.49 ± 0.28 | -2.29 ± 0.29 |
| PA Mean Pressure | -2.90 ± 0.34 | -1.77 ± 0.35 | -2.80 ± 0.35 | -2.40 ± 0.36 |
Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using an area under the curve (AUC) analysis of change from baseline on all PA pressure readings through 12 months.
| mmHg*Days | Randomized Arm - Treatment Group | Randomized Arm - Control Group |
|---|---|---|
| PA Systolic Pressure | -945.0 ± 2328.9 | -621.2 ± 2242.3 |
| PA Diastolic pressure | -690.5 ± 1405.1 | -566.1 ± 1360.6 |
| PA Mean Pressure | -792.7 ± 1767.0 | -582.9 ± 1698.1 |
Change in BNP measurements from baseline
| pg/mL | Randomized Arm - Treatment Group | Randomized Arm - Control Group |
|---|---|---|
| (Randomized Arm) BNP | -72.16 ± 52.46 | -34.96 ± 54.33 |
Change in BNP measurements from baseline
| pg/mL | Randomized Arm - Treatment Group | Randomized Arm - Control Group |
|---|---|---|
| (Randomized Arm) BNP | -80.61 ± 53.17 | -20.82 ± 55.51 |
Change in NT-proBNP measurements from baseline
| pg/mL | Randomized Arm - Treatment Group | Randomized Arm - Control Group |
|---|---|---|
| (Randomized Arm) NT-proBNP | -169.94 ± 183.37 | 298.16 ± 179.58 |
Change in NT-proBNP measurements from baseline
| pg/mL | Randomized Arm - Treatment Group (12 Month) | Randomized Arm - Control Group (12 Month) |
|---|---|---|
| (Randomized Arm) NT-proBNP | 217.23 ± 190.28 | 501.90 ± 189.74 |
The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation in the Treatment group
| events per patient-year | Randomized Arm - Treatment Group (One Year Prior to Implant) | Randomized Arm - Treatment Group (One Year After Implant) |
|---|---|---|
| (Randomized Arm) HFHs Post- vs. Pre-implantation [Treatment Group] | 0.643 | 0.415 |
The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation
| events per patient-year | Randomized Arm - Control Group (One Year Prior to Implant) | Randomized Arm - Control Group (One Year After Implant) |
|---|---|---|
| (Randomized Arm) HFHs Post- vs. Pre-implantation [Control Group] | 0.710 | 0.483 |
Health status as assessed by the KCCQ-12 The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life on a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status.
| scores on a scale | Single Arm - Elevated NT-proBNP/BNP Only | Single Arm - Previous HF Hospitalization Only | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization |
|---|---|---|---|
| (Single Arm) KCCQ-12 [Mixed Model Analysis] | 6.19 ± 0.98 | 5.47 ± 0.90 | 10.70 ± 1.18 |
Health status as assessed by the KCCQ-12 The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life on a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status.
| scores on a scale | Single Arm - Elevated NT-proBNP/BNP Only | Single Arm - Previous HF Hospitalization Only | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization |
|---|---|---|---|
| (Single Arm) KCCQ-12 [Mixed Model Analysis] | 6.53 ± 1.07 | 5.00 ± 0.99 | 11.85 ± 1.32 |
Health status as assessed by the EQ-5D-5L Questionnaire. The data represents the EQ Visual Analogue Scale (VAS) subscale. The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score for represents a better quality of life.
| scores on a scale | Single Arm - Elevated NT-proBNP/BNP Only | Single Arm - Previous HF Hospitalization Only | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization |
|---|---|---|---|
| (Single Arm) EQ-5D-5L [Mixed Model Analysis] | 3.86 ± 0.91 | 3.05 ± 0.83 | 2.41 ± 1.09 |
Health status as assessed by the EQ-5D-5L Questionnaire. The data represents the EQ Visual Analogue Scale (VAS) subscale. The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score for represents a better quality of life.
| scores on a scale | Single Arm - Elevated NT-proBNP/BNP Only | Single Arm - Previous HF Hospitalization Only | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization |
|---|---|---|---|
| (Single Arm) EQ-5D-5L [Mixed Model Analysis] | 3.42 ± 0.94 | 0.83 ± 0.88 | 4.93 ± 1.16 |
6MHW Test Distance
| meters, m | Single Arm - Elevated NT-proBNP/BNP Only [6 Month] | Single Arm - Previous HF Hospitalization Only [6 Month] | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [6 Month] |
|---|---|---|---|
| (Single Arm) 6MHW Test [Mixed Model Analysis] | 5.25 ± 5.40 | 0.67 ± 5.13 | 20.11 ± 6.62 |
6MHW Test Distance
| meters, m | Single Arm - Elevated NT-proBNP/BNP Only [12 Month] | Single Arm - Previous HF Hospitalization Only [12 Month] | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [12 Month] |
|---|---|---|---|
| (Single Arm) 6MHW Test [Mixed Model Analysis] | -3.80 ± 5.90 | -5.56 ± 5.99 | 20.18 ± 7.67 |
The number of deaths of cardiovascular cause
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only | Single Arm - Previous HF Hospitalization Only | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization |
|---|---|---|---|
| (Single Arm) Cardiovascular Mortality | 0.073 | 0.090 | 0.163 |
The number of hospitalizations of any cause
| events per patient-year | Single Arm - Elevated NT-proBNP/BNP Only | Single Arm - Previous HF Hospitalization Only | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization |
|---|---|---|---|
| (Single Arm) All-cause Hospitalizations | 0.80 | 1.216 | 1.503 |
The frequency of subject uploads of PA pressure
| Percentage | Single Arm - Elevated NT-proBNP/BNP Only | Single Arm - Previous HF Hospitalization Only | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization |
|---|---|---|---|
| (Single Arm) Frequency of Subject PA Pressure Uploads - Daily Compliance | 79 ± 22 | 72 ± 27 | 74 ± 25 |
The frequency of subject uploads of PA pressure
| Percentage | Single Arm - Elevated NT-proBNP/BNP Only | Single Arm - Previous HF Hospitalization Only | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization |
|---|---|---|---|
| (Single Arm) Frequency of Subject PA Pressure Uploads - Weekly Compliance | 0.94 ± 0.14 | 0.90 ± 0.20 | 0.91 ± 0.17 |
The number of changes in HF medications
| Number of events | Single Arm - Elevated NT-proBNP/BNP Only | Single Arm - Previous HF Hospitalization Only | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization |
|---|---|---|---|
| Diuretics | 3026 | 4573 | 2630 |
| Angiotensin-Converting Enzyme (ACE) Inhibitors | 50 | 69 | 42 |
| Angiotensin Receptor Blocker (ARB) | 61 | 127 | 57 |
| Angiotensin Receptor-Neprilysin Inhibitor (ARNi) | 122 | 135 | 98 |
| Beta Blockers | 285 | 358 | 239 |
| Mineralocorticoid Receptor Antagonist | 238 | 409 | 216 |
| SGLT2 Inhibitor | 73 | 66 | 46 |
| Nitrates | 68 | 88 | 68 |
| Hydralazine/Other Vasodilators | 93 | 121 | 102 |
| Calcium Channel Blockers | 48 | 82 | 48 |
| Digoxin | 37 | 23 | 18 |
| Sinus Node If Channel Inhibitors | 2 | 3 | 1 |
Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using a mixed linear model at fixed time points (Baseline, 6 months, and 12 months) producing least-squares means.
| mmHg | Single Arm - Elevated NT-proBNP/BNP Only [6 Month] | Single Arm - Previous HF Hospitalization Only [6 Month] | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [6 Month] | Single Arm - Elevated NT-proBNP/BNP Only [12 Month] | Single Arm - Previous HF Hospitalization Only [12 Month] | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [12 Month] |
|---|---|---|---|---|---|---|
| Change in PA Systolic Pressure | -3.79 ± 0.43 | -3.32 ± 0.39 | -3.86 ± 0.52 | -3.49 ± 0.49 | -3.34 ± 0.46 | -4.32 ± 0.60 |
| Change in PA Diastolic Pressure | -2.93 ± 0.26 | -2.34 ± 0.24 | -2.66 ± 0.31 | -2.71 ± 0.29 | -2.57 ± 0.27 | -3.17 ± 0.36 |
| Change in PA Mean Pressure | -3.22 ± 0.32 | -2.73 ± 0.29 | -3.07 ± 0.39 | -2.92 ± 0.36 | -2.84 ± 0.34 | -3.60 ± 0.44 |
Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using area under the curve (AUC) analysis of PA pressure across the full follow-up period
| mmHg*Days | Single Arm - Elevated NT-proBNP/BNP Only | Single Arm - Previous HF Hospitalization Only | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization |
|---|---|---|---|
| PA Systolic Pressure | -1033.79 ± 2457.95 | -1021.13 ± 2374.17 | -1179.42 ± 2588.90 |
| PA Diastolic Pressure | -868.16 ± 1410.07 | -723.29 ± 1529.73 | -847.94 ± 1489.96 |
| PA Mean Pressure | -929.39 ± 1794.20 | -832.21 ± 1832.20 | -973.97 ± 1904.05 |
Either change in N-terminal pro-brain natriuretic peptide (NT-proBNP) or Brain natriuretic peptide (BNP) measurements at 6 months visits from baseline.
| pg/mL | Single Arm - Elevated NT-proBNP/BNP Only | Single Arm - Previous HF Hospitalization Only | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization |
|---|---|---|---|
| BNP | 40.81 ± 38.50 | -103.33 ± 32.91 | -6.45 ± 41.50 |
| NT-proBNP | -55.40 ± 153.36 | -174.83 ± 151.97 | -102.91 ± 194.87 |
Either change in N-terminal pro-brain natriuretic peptide (NT-proBNP) or Brain natriuretic peptide (BNP) measurements at 6 months and 12 months visits from baseline.
| pg/mL | Single Arm - Elevated NT-proBNP/BNP Only | Single Arm - Previous HF Hospitalization Only | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization |
|---|---|---|---|
| BNP | -11.23 ± 37.73 | -79.01 ± 32.23 | -17.71 ± 41.92 |
| NT-proBNP | -15.17 ± 206.01 | 348.49 ± 214.19 | 259.33 ± 279.57 |
Collected over Adverse device effects (ADEs), serious adverse device effects (SADEs), serious adverse events (SAEs), and unanticipated adverse device effects (UADEs) were summarized for subjects enrolled in this trial as number of events, the number and percentage of subjects with events and event rate as number of events/subject-month. Adverse event data were collected during the 1-year follow-up period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Randomized Arm - Treatment Group | 40/497 (8%) | 283/497 (56.9%) | 15/497 (3%) |
| Randomized Arm - Control Group | 37/503 (7.4%) | 272/503 (54.1%) | 20/503 (4%) |
| Single Arm | 190/1,358 (14%) | 820/1,358 (60.4%) | 33/1,358 (2.4%) |
| Event | Randomized Arm - Treatment Group | Randomized Arm - Control Group | Single Arm |
|---|---|---|---|
| Cardiac Failure CongestiveCardiac disorders | 130/497 | 155/503 | 454/1358 |
| ArrhythmiaCardiac disorders | 47/497 | 46/503 | 138/1358 |
| InfectionInfections and infestations | 27/497 | 34/503 | 103/1358 |
| Renal Failure AcuteRenal and urinary disorders | 18/497 | 28/503 | 81/1358 |
| PneumoniaInfections and infestations | 24/497 | 29/503 | 71/1358 |
| Chest PainGeneral disorders | 27/497 | 23/503 | 32/1358 |
| Gastrointestinal HemorrhageGastrointestinal disorders | 9/497 | 16/503 | 52/1358 |
| SepsisInfections and infestations | 17/497 | 10/503 | 48/1358 |
| Blood Creatinine IncreasedInjury, poisoning and procedural complications | 17/497 | 13/503 | 43/1358 |
| Myocardial InfarctionCardiac disorders | 10/497 | 16/503 | 30/1358 |
| Event | Randomized Arm - Treatment Group | Randomized Arm - Control Group | Single Arm |
|---|---|---|---|
| Catheter Site HemorrhageGeneral disorders | 4/497 | 6/503 | 10/1358 |
| HemoptysisRespiratory, thoracic and mediastinal disorders | 3/497 | 0/503 | 2/1358 |
| Catheter Site HematomaGeneral disorders | 2/497 | 3/503 | 2/1358 |
| Device DislocationGeneral disorders | 0/497 | 3/503 | 7/1358 |
| Device Information Output IssueGeneral disorders | 2/497 | 2/503 | 0/1358 |
| ArrhythmiaCardiac disorders | 0/497 | 2/503 | 3/1358 |
| Vessel Puncture Site PainGeneral disorders | 1/497 | 1/503 | 0/1358 |
| Arterial InjuryInjury, poisoning and procedural complications | 1/497 | 0/503 | 0/1358 |
| LacerationInjury, poisoning and procedural complications | 1/497 | 0/503 | 0/1358 |
| PresyncopeNervous system disorders | 1/497 | 0/503 | 1/1358 |
The endpoint-contributing population consists of patients who were successfully implanted.
| Age, Continuous(years) | Randomized Arm - Treatment Group | Randomized Arm - Control Group | Single Arm | Total |
|---|---|---|---|---|
| Mean | 69.2 ± 11.1 | 69.2 ± 11.0 | 70.5 ± 10.9 | 69.9 ± 11.0 |
| Sex: Female, Male(Participants) | Randomized Arm - Treatment Group | Randomized Arm - Control Group | Single Arm | Total |
|---|---|---|---|---|
| Female | 187 | 188 | 584 | 959 |
| Male | 310 | 315 | 774 | 1399 |
| Ethnicity (NIH/OMB)(Participants) | Randomized Arm - Treatment Group | Randomized Arm - Control Group | Single Arm | Total |
|---|---|---|---|---|
| Hispanic or Latino | 16 | 17 | 61 | 94 |
| Not Hispanic or Latino | 477 | 483 | 1283 | 2243 |
| Unknown or Not Reported | 4 | 3 | 14 | 21 |
| Race (NIH/OMB)(Participants) | Randomized Arm - Treatment Group | Randomized Arm - Control Group | Single Arm | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 4 | 6 |
| Asian | 0 | 1 | 12 | 13 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 3 | 3 |
| Black or African American | 86 | 93 | 188 | 367 |
| White | 403 | 404 | 1125 | 1932 |
| More than one race | 1 | 1 | 3 | 5 |
| Unknown or Not Reported | 6 | 3 | 23 | 32 |
| Body Mass Index(kg/m2) | Randomized Arm - Treatment Group | Randomized Arm - Control Group | Single Arm | Total |
|---|---|---|---|---|
| Mean | 32.9 ± 8.3 | 33.8 ± 8.4 | 34.0 ± 8.8 | 33.8 ± 8.7 |
| New York Heart Association (NYHA) Class(Participants) | Randomized Arm - Treatment Group | Randomized Arm - Control Group | Single Arm | Total |
|---|---|---|---|---|
| Class II | 146 | 150 | 0 | 296 |
| Class III | 322 | 328 | 1356 | 2006 |
| Class IV | 29 | 25 | 1 | 55 |
| Medical History - Ischemic etiology(Participants) | Randomized Arm - Treatment Group | Randomized Arm - Control Group | Single Arm | Total |
|---|---|---|---|---|
| Count of participants | 207 | 190 | 489 | 886 |
| Medical History - Previous myocardial infarction(Participants) | Randomized Arm - Treatment Group | Randomized Arm - Control Group | Single Arm | Total |
|---|---|---|---|---|
| Count of participants | 144 | 158 | 359 | 661 |
37 further baseline measures are reported on the registry.
Showing the first 100 of 129 sites across 2 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in May 2023, 62 months.
Results were first posted in Aug 2025, 2 years 2 months after primary completion.
Of 236 industry-sponsored interventional studies with no phase under Heart Failure, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 62. This study's 62 months is above that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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