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CompletedNCT02954341Updated Feb 24, 2025Results posted

CardioMEMS HF System OUS Post Market Study

An observational study in Heart Failure, Left-Sided Heart Failure and Congestive Heart Failure, sponsored by Abbott Medical Devices. Completed at 5 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-24.

Sponsored by Abbott Medical Devices · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
321
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this Post Market Study (PMS) is to evaluate the use of the CardioMEMS HF System in patients with New York Heart Association (NYHA) Class III Heart Failure in a commercial setting.

02

Conditions studied

  • Heart Failure
  • Left-Sided Heart Failure
  • Congestive Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 321 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults with New York Heart Association (NYHA) Class III Heart Failure (HF) who have experienced a heart failure hospitalization within the past 12 months.

Inclusion criteria

  1. Written informed consent obtained from subject
  2. ≥ 18 years of age
  3. Diagnosis of NYHA Class III Heart Failure
  4. At least 1 HF hospitalization within 12 months of Baseline visit
  5. Subjects with reduced LVEF heart failure should be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the subject is intolerant to beta blockers, ACE-I or ARB.
  6. Subjects with a BMI ≤ 35. Subjects with BMI >35 will require their chest circumference to be measured at the axillary level, if > 65 inches the patient will not be eligible for the study.
  7. Subjects with pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the RHC)
  8. Subjects willing and able to comply with the follow-up requirements of the study

Exclusion criteria

Exclusion Criteria:

  1. Subjects with an active infection
  2. Subjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosis
  3. Subjects who, in the Investigator's opinion, are unable to tolerate a right heart catheterization
  4. Subjects who have had a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within 2 months of Baseline Visit
  5. Subjects with Cardiac Resynchronization Device (CRT) implanted \< 3 months prior to enrollment
  6. Subjects with a Glomerular Filtration Rate (GFR) \< 25 ml/min (obtained within 2 weeks of the baseline visit) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
  7. Subjects with congenital heart disease or mechanical right heart valve(s)
  8. Subjects likely to undergo heart transplantation or VAD within 6 months of baseline visit
  9. Subjects with known coagulation disorders
  10. Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel (not applicable for subjects taking anti-coagulation therapy or other approved anti-platelets therapy).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
321 participants (actual)
Patient registry
No

Interventions

  • DeviceCardioMEMS HF System
06

What researchers measure

Primary outcomes

  1. Freedom From Device/System Related Complications

    A device/System related complication (DSRC) is an adverse event that is, or is possibly, related to the device/system (wireless pressure sensor or external electronics) and has at least one of the following characteristics: 1) is treated with invasive means (other than intramuscular medication or right heart catheterization which is used for diagnostic purposes); 2) results in death of the subject; 3) results in the explant of the device.

    Time frame: Two year

  2. Freedom From Pressure Sensor Failure.

    A sensor failure occurs when no readings can be obtained from it after troubleshooting the system to rule out any problems with the external electronics.

    Time frame: Two year

  3. Annualized Heart Failure Hospitalization (HFH) Rate at 1 Year Compared to the HF Hospitalization Rate in the Year Prior to Enrollment.

    HFH events at 1 year versus the HFH events in the year prior to enrollment

    Time frame: One year

07

Results

Posted Feb 24, 2025

Participant flow

Participant flow — Overall Study
MilestoneConsented Population
Started321
Underwent implant (safety population)304
Successfully implanted (effectiveness population)299
Completed190
Not completed131
Withdrew: Attempted implant unsuccessful5
Withdrew: Death90
Withdrew: Withdrawal by subject4
Withdrew: Physician decision13
Withdrew: Not implanted due to covid restrictions1
Withdrew: Not implanted due to physician's decision1
Withdrew: Withdrawn prior implant attempt17

Outcome measures

PrimaryFreedom From Device/System Related Complications

A device/System related complication (DSRC) is an adverse event that is, or is possibly, related to the device/system (wireless pressure sensor or external electronics) and has at least one of the following characteristics: 1) is treated with invasive means (other than intramuscular medication or right heart catheterization which is used for diagnostic purposes); 2) results in death of the subject; 3) results in the explant of the device.

Time frame:
Two year
Reported as:
Count of participants · Participants
Freedom From Device/System Related Complications
ParticipantsSafety Population
Freedom From Device/System Related Complications304
PrimaryFreedom From Pressure Sensor Failure.

A sensor failure occurs when no readings can be obtained from it after troubleshooting the system to rule out any problems with the external electronics.

Time frame:
Two year
Reported as:
Count of participants · Participants
Freedom From Pressure Sensor Failure.
ParticipantsEffectiveness Population
Freedom From Pressure Sensor Failure.298
PrimaryAnnualized Heart Failure Hospitalization (HFH) Rate at 1 Year Compared to the HF Hospitalization Rate in the Year Prior to Enrollment.

HFH events at 1 year versus the HFH events in the year prior to enrollment

Time frame:
One year
Reported as:
Number · HFH events per year
Annualized Heart Failure Hospitalization (HFH) Rate at 1 Year Compared to the HF Hospitalization Rate in the Year Prior to Enrollment.
HFH events per yearEffectiveness Population
Annualized HFH rate in the 12Months prior CardioMEMS implant1.59 (1.47 to 1.71)
Annualized HFH rate in the 12Months post CardioMEMS implant0.49 (0.40 to 0.59)
Annualized HFH rate post-Implant vs pre-implant0.31 (0.25 to 0.37)

Adverse events

Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Safety Population90/304 (29.6%)225/304 (74%)17/304 (5.6%)
Most frequent serious events
Showing 10 of 20
Most frequent serious events
EventSafety Population
Decompensated Heart FailureCardiac disorders134/304
OtherGeneral disorders131/304
InfectionInfections and infestations43/304
Abnormal heart rate or rhythmCardiac disorders40/304
Renal FailureRenal and urinary disorders32/304
Chest pain - cardiacCardiac disorders14/304
SepsisInfections and infestations14/304
Exacerbation of COPDRespiratory, thoracic and mediastinal disorders4/304
Myocardial InfarctionCardiac disorders4/304
StrokeVascular disorders4/304
Most frequent other events
Most frequent other events
EventSafety Population
OtherGeneral disorders7/304
Decompensated Heart FailureCardiac disorders3/304
Renal FailureRenal and urinary disorders3/304
InfectionInfections and infestations1/304
Abnormal heart rate or rhythmCardiac disorders1/304
Pulmonary infarctRespiratory, thoracic and mediastinal disorders1/304
ThrombusVascular disorders1/304

Baseline characteristics

Patients who underwent a successful implant constitute the Effectiveness Population

Age, Continuous
Age, Continuous(years)Effectiveness Population
Mean68.5 ± 11.7
Sex: Female, Male
Sex: Female, Male(Participants)Effectiveness Population
Female81
Male218
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Effectiveness Population
Ischemic Cardiomyopathy
Ischemic Cardiomyopathy(Participants)Effectiveness Population
Count of participants137
CRT/CRT-D
CRT/CRT-D(Participants)Effectiveness Population
Count of participants87
ICD
ICD(Participants)Effectiveness Population
Count of participants71
Preserved Ejection Fraction (EF)
Preserved Ejection Fraction (EF)(Participants)Effectiveness Population
Count of participants106
Hypertension
Hypertension(Participants)Effectiveness Population
Count of participants164

6 further baseline measures are reported on the registry.

08

Study locations

5 sites
  • The Prince Charles Hospital
    Chermside, Queensland 4032, Australia
  • CHR Citadelle
    Liège, Belgium
  • Rigshospitalet
    Copenhagen, Denmark
  • CHRU de Lille
    Lille, France
  • Royal Bromptom Hospital
    London, United Kingdom
09

References and documents

Publications

  • Cowie MR, Flett A, Cowburn P, Foley P, Chandrasekaran B, Loke I, Critoph C, Gardner RS, Guha K, Betts TR, Carr-White G, Zaidi A, Lim HS, Hayward C, Patwala A, Rogers D, Pettit S, Gazzola C, Henderson J, Adamson PB. Real-world evidence in a national health service: results of the UK CardioMEMS HF System Post-Market Study. ESC Heart Fail. 2022 Feb;9(1):48-56. doi: 10.1002/ehf2.13748. Epub 2021 Dec 9. PubMed 34882989 ↗
  • Cowie MR, de Groote P, McKenzie S, Brett ME, Adamson PB; CardioMEMS Post-Market Study Investigators. Rationale and design of the CardioMEMS Post-Market Multinational Clinical Study: COAST. ESC Heart Fail. 2020 Jun;7(3):865-872. doi: 10.1002/ehf2.12646. Epub 2020 Feb 7. PubMed 32031758 ↗

Study documents

  • Protocol and statistical analysis plan · Apr 18, 2018
  • Informed consent form · May 15, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02954341
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Nov 3, 2016
Start date
Jul 2016
Primary completion
Dec 8, 2023
Completion
Dec 8, 2023
Results posted
Feb 24, 2025
Last update
Feb 24, 2025

Study contacts

Pascal De Groote, MD
study chair · CHU de Lille - Institut Coeur Poumon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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