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CompletedNCT03476187BMADHFUpdated Jan 8, 2025Results posted

Benefits of µCor in Ambulatory Decompensated Heart Failure

An interventional study of µCor in Heart Failure, sponsored by Zoll Medical Corporation. Completed at 61 sites in 3 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-01-08.

Sponsored by Zoll Medical Corporation · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
257
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study summary

Subjects meeting the inclusion/exclusion criteria will wear the µCor for at least 90 days. During the study, clinic follow up will occur every 30 days. For all subjects, each scheduled clinic visit will include assessment of cardiac symptoms and any relevant clinically actionable events. The subject will be given a daily diary to track symptoms, unplanned hospital visits, medication changes, and all other heart failure related clinical events. Weekly phone calls to the subject will be given throughout the duration of the study to remind the patient to use the subject diary and to collect and record heart failure related clinical events. Subjects will be contacted six months and one year from initial enrollment to assess the vital status of the subject, any heart failure related clinical events since the end of µCor wear, and any health care utilization since the end of µCor wear.

Read the detailed description

Subjects meeting the inclusion/exclusion criteria will wear µCor for 90 days from the day of fitting. 500 total patients will be enrolled. There will be an interim analysis when the 200th subject has finished the study in the study to assess for distribution of patients with reduced and preserved LVEF.

Subjects will be fitted with µCor during hospital discharge or within a clinic visit that has occurred within 10 days of a heart failure related hospitalization. The µCor fitting will mark day 0 of the study. An LVEF measurement will be recorded during enrollment or within 30 days post enrollment if an LVEF measurement has not been recorded within 30 days prior to enrollment. An investigator assessment will be performed during all clinic visits. The assessment template is shown in Appendix A.

Subjects will be given a diary at enrollment that will ask them to rate their degree of specific symptoms of heart failure such as shortness of breath and fatigue as well as mark any heart failure related clinical events or medication changes that have occurred since the last entry.

Study follow up visits will occur at day 30, day 60, and day 90. During follow up visits the subjects will be asked about any heart failure related clinical events or change in symptoms that have occurred since the last follow up. The subject will receive a study based weekly phone call asking the subject about any recent heart failure related clinical events or change in heart failure symptoms. During the weekly phone call the subject will be reminded to fill out the daily diary. No phone calls will be given on the week where there is a study follow up visit. There will be 9 total phone calls.

During the Day 90 visit, the subject will be given the option to continue wearing the µCor for an additional 90 days. Furthermore, if the subject experienced a heart failure related clinical event within the initial 90 days of wear, the subject will be given the option of wearing the µCor for 30 days following the heart failure event. .If the subject chooses additional wear time, weekly phone calls and monthly visits will be structured identical to that of the main study period. The µCor will be returned at end of use.

There will be a follow up at six months and one year post enrollment to document mortality data, heart failure related clinical events, and health care utilization data.

02

Conditions studied

  • Heart Failure

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03

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects either hospitalized for decompensated systolic, diastolic, or combined heart failure or subjects presenting at an outpatient clinic with a history of hospital discharge for decompensated systolic, diastolic, or combined heart failure within the previous 10 days.
  • All subjects must be 21 years of age or older on the day of screening.

Exclusion criteria

Exclusion Criteria:

  • Subjects who are wearing the wearable cardioverter defibrillator (WCD)
  • Subjects not expected to survive one year from enrollment from non-cardiac disease.
  • Subjects with skin allergy or sensitivity to medical adhesives.
  • Subjects anticipated to start dialysis within 90 days.
  • Subjects currently implanted with an S-ICD system.
  • Subjects whose primary diagnosis on hospital admission was Acute Coronary Syndrome (ACS) STEMI/NSTEMI rather than heart failure exacerbation.
  • Subjects who are unable to participate in all follow up visits.
  • Subjects participating in any other research at time of enrollment.
  • Subjects currently implanted with an LVAD.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
257 participants (actual)

Study arms

  • Experimental
    µCor wearers

    Wear the µCor device

    Device: µCor

Interventions

  • DeviceµCor

    Monitor with µCor

05

What researchers measure

Primary outcomes

  1. Correlation of μCor Readings to Heart Failure Related Clinical Events

    HF Event: a hospitalization primarily due to heart failure within 90 days. Time window: The 7 days prior to the 1st heart failure hospitalization, or the final 7 days of device wear if no HF event occurred.

    Time frame: 3 months

  2. Correlation of µCor Readings to Heart Failure Related Clinical Events

    Definitions: Daytime: 7:00 AM - 12:00 AM Nighttime: 12:00 AM - 7:00 AM For each day on which the subject wore the device, the following values were calculated: Daytime activity: The proportion of minutes while wearing the device that the subject spent active (unitless). Nighttime heart rate: The median heart rate while wearing the device during the night (beats/min) Thoracic fluid index: The median proportion of ratio of radiofrequency-measured lung fluid readings compared to the subject's baseline (unitless). Nighttime posture: The median pitch angle while wearing the device during the night (degrees, where 0 is the horizontal). Nighttime respiration: The median respiration rate while wearing the device during the night (breaths/min) HF event: a hospitalization primarily due to heart failure

    Time frame: 3 months

Secondary outcomes

  1. Establishment of Rate of Occurrence of VT/VF Episodes and Arrhythmic Death in Subjects

    Rate of occurrence of VT/VF episodes at the time of enrollment in the study and rate of occurrence of arrhythmic death in subjects at 90 days and 1 year.

    Time frame: Baseline, 90 days, 1 YR

  2. Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve

    During office visits at months 1, 2, and 3, subjects reported their degrees of dyspnea, orthopnea, and fatigue on the following scale: \[none, seldom, frequent, continuous\]. Each day that the subject wore the device, a daily median was calculated for the following measures: \[thoracic fluid index (TFI), nighttime heart rate (HR), nighttime respiration rate (RR)\]. Nighttime was defined as 12:00 AM - 7:00 AM.

    Time frame: 3 months

  3. Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms

    During office visits at months 1, 2, and 3, subjects reported their degrees of dyspnea, orthopnea, and fatigue on the following scale: \[none, seldom, frequent, continuous\]. Each day that the subject wore the device, a daily median was calculated for the following measures: \[thoracic fluid index (TFI), nighttime heart rate (HR), nighttime respiration rate (RR)\]. Nighttime was defined as 12:00 AM - 7:00 AM.

    Time frame: 3 months

  4. Frequency of Subject Reported Symptoms

    During weekly phone calls and monthly office visits, subjects reported whether they experienced new arrhythmia and/or heart failure symptoms. Results indicate the number of times that subjects reported each of these two symptoms.

    Time frame: 3 months

  5. Timing of Subject Reported Symptoms

    During weekly phone calls and monthly office visits, subjects reported whether they experienced new arrhythmia and/or heart failure symptoms. Results indicate the median number of weeks until a subject's first symptom report of each type.

    Time frame: 3 months

  6. Severity of Subject Reported Symptoms

    Each subject was expected to undergo an in-person office visit at the site on months 0, 1, 2, and 3 in which they reported the severity of their heart failure symptoms. Results indicate the number of subjects reporting each severity level of each symptom at each office visit.

    Time frame: 3 months

  7. Hospital Readmission Rate During the Study Period

    During weekly phone calls and monthly office visits, subjects reported whether they experienced a new hospitalization since their last call/visit. An adjudication committee of physicians determined whether each hospitalization was due to HF or not.

    Time frame: 3 months

  8. Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study

    At the time of enrollment, subjects reported how many hospitalizations they experienced in the 90 days prior to enrollment. Results indicate the number of subjects who reported a hospitalization in this time window.

    Time frame: 3 months

  9. Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study

    At the time of enrollment, subjects reported how many hospitalizations they experienced in the 90 days prior to enrollment. Results indicate the median number of hospitalizations reported per subject in this time window.

    Time frame: 3 months

  10. Mortality, Heart Failure Related Events, and Health Care Utilization Data at Six Months and One Year Post Enrollment

    During weekly phone calls, monthly office visits, the 6-month phone call, and the 1-year phone call, subjects reported whether they experienced a hospitalization, ER visit, or unplanned doctor's office visit since the last call/visit. An adjudication committee of physicians determined whether each hospitalization was due to HF or not. On each subject's final date of study participation, their survival status was recorded.

    Time frame: 6 months and 1 year

06

Results

Posted Aug 28, 2024
Limitations and caveats
This study was conducted from 8/17/2018 to 12/1/2022 and partially overlapped with the COVID-19 Pandemic.

Participant flow

Participant flow — Overall Study
MilestoneµCor Wearers
Started257
Completed245
Not completed12
Withdrew: Protocol violation7
Withdrew: Physician decision5

Outcome measures

PrimaryCorrelation of μCor Readings to Heart Failure Related Clinical Events

HF Event: a hospitalization primarily due to heart failure within 90 days. Time window: The 7 days prior to the 1st heart failure hospitalization, or the final 7 days of device wear if no HF event occurred.

Time frame:
3 months
Reported as:
Number · participants
Correlation of μCor Readings to Heart Failure Related Clinical Events
participantsµCor Wearers
Valid device data within time window : HF Event34
Valid device data within time window : No HF Event173
No valid device data within time window : HF Event16
No valid device data within time window : No HF Event22
PrimaryCorrelation of µCor Readings to Heart Failure Related Clinical Events

Definitions: Daytime: 7:00 AM - 12:00 AM Nighttime: 12:00 AM - 7:00 AM For each day on which the subject wore the device, the following values were calculated: Daytime activity: The proportion of minutes while wearing the device that the subject spent active (unitless). Nighttime heart rate: The median heart rate while wearing the device during the night (beats/min) Thoracic fluid index: The median proportion of ratio of radiofrequency-measured lung fluid readings compared to the subject's baseline (unitless). Nighttime posture: The median pitch angle while wearing the device during the night (degrees, where 0 is the horizontal). Nighttime respiration: The median respiration rate while wearing the device during the night (breaths/min) HF event: a hospitalization primarily due to heart failure

Time frame:
3 months
Reported as:
Median · Probability
Correlation of µCor Readings to Heart Failure Related Clinical Events
ProbabilityµCor Wearers
Daytime Activity0.35 (0.26 to 0.45)
Nighttime Heart Rate0.59 (0.48 to 0.70)
Thoracic Fluid Index0.59 (0.49 to 0.68)
Nighttime Posture0.59 (0.49 to 0.70)
Nighttime Respiration0.59 (0.48 to 0.70)
SecondaryEstablishment of Rate of Occurrence of VT/VF Episodes and Arrhythmic Death in Subjects

Rate of occurrence of VT/VF episodes at the time of enrollment in the study and rate of occurrence of arrhythmic death in subjects at 90 days and 1 year.

Time frame:
Baseline, 90 days, 1 YR
Reported as:
Number · participants
Establishment of Rate of Occurrence of VT/VF Episodes and Arrhythmic Death in Subjects
participantsµCor Wearers
VT at baseline10
VF at baseline3
VT (non-sustained) at baseline12
Arrhythmic death at 1 year2
Arrhythmic death at 90 days1
SecondaryCorrelation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve

During office visits at months 1, 2, and 3, subjects reported their degrees of dyspnea, orthopnea, and fatigue on the following scale: \[none, seldom, frequent, continuous\]. Each day that the subject wore the device, a daily median was calculated for the following measures: \[thoracic fluid index (TFI), nighttime heart rate (HR), nighttime respiration rate (RR)\]. Nighttime was defined as 12:00 AM - 7:00 AM.

Time frame:
3 months
Reported as:
Number · Probability
Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve
ProbabilityµCor Wearers
Dyspnea - TFI0.56 (0.49 to 0.62)
Dyspnea - HR0.53 (0.46 to 0.60)
Dyspnea - RR0.47 (0.40 to 0.54)
Orthopnea - TFI0.54 (0.46 to 0.62)
Orthopnea - HR0.59 (0.51 to 0.67)
Orthopnea - RR0.55 (0.47 to 0.64)
Fatigue - TFI0.57 (0.50 to 0.63)
Fatigue - HR0.55 (0.48 to 0.62)
Fatigue - RR0.47 (0.40 to 0.54)
SecondaryCorrelation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms

During office visits at months 1, 2, and 3, subjects reported their degrees of dyspnea, orthopnea, and fatigue on the following scale: \[none, seldom, frequent, continuous\]. Each day that the subject wore the device, a daily median was calculated for the following measures: \[thoracic fluid index (TFI), nighttime heart rate (HR), nighttime respiration rate (RR)\]. Nighttime was defined as 12:00 AM - 7:00 AM.

Time frame:
3 months
Reported as:
Number · Symptoms
Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms
SymptomsµCor Wearers With Mild SymptomsuCor Wearers With Severe Symptoms
Dyspnea - TFI147124
Dyspnea - HR135117
Dyspnea - RR136124
Orthopnea - TFI20665
Orthopnea - HR19057
Orthopnea - RR19764
Fatigue - TFI134141
Fatigue - HR120126
Fatigue - RR128130
SecondaryFrequency of Subject Reported Symptoms

During weekly phone calls and monthly office visits, subjects reported whether they experienced new arrhythmia and/or heart failure symptoms. Results indicate the number of times that subjects reported each of these two symptoms.

Time frame:
3 months
Reported as:
Count of participants · Participants
Frequency of Subject Reported Symptoms
ParticipantsµCor Wearers
Frequency of self-reported arrhythmia symptoms — 0 Arrhythmia symptoms123
Frequency of self-reported arrhythmia symptoms — 1 Arrhythmia symptom52
Frequency of self-reported arrhythmia symptoms — 2 Arrhythmia symptoms22
Frequency of self-reported arrhythmia symptoms — 3 Arrhythmia symptoms17
Frequency of self-reported arrhythmia symptoms — 4 Arrhythmia symptoms3
Frequency of self-reported arrhythmia symptoms — 5 Arrhythmia symptoms8
Frequency of self-reported arrhythmia symptoms — 6+ Arrhythmia symptoms3
Frequency of self-reported heart failure symptoms — 0 Arrhythmia symptoms83
Frequency of self-reported heart failure symptoms — 1 Arrhythmia symptom62
Frequency of self-reported heart failure symptoms — 2 Arrhythmia symptoms30
Frequency of self-reported heart failure symptoms — 3 Arrhythmia symptoms21
Frequency of self-reported heart failure symptoms — 4 Arrhythmia symptoms9
Frequency of self-reported heart failure symptoms — 5 Arrhythmia symptoms10
Frequency of self-reported heart failure symptoms — 6+ Arrhythmia symptoms13
SecondaryTiming of Subject Reported Symptoms

During weekly phone calls and monthly office visits, subjects reported whether they experienced new arrhythmia and/or heart failure symptoms. Results indicate the median number of weeks until a subject's first symptom report of each type.

Time frame:
3 months
Reported as:
Median · Weeks
Timing of Subject Reported Symptoms
WeeksuCor Wearers
Time from start of study until first arrhythmia symptom report (median, interquartile range)4 (2 to 6)
Time from start of study until first heart failure symptom report (median, interquartile range)3 (2 to 5)
SecondarySeverity of Subject Reported Symptoms

Each subject was expected to undergo an in-person office visit at the site on months 0, 1, 2, and 3 in which they reported the severity of their heart failure symptoms. Results indicate the number of subjects reporting each severity level of each symptom at each office visit.

Time frame:
3 months
Reported as:
Count of participants · Participants
Severity of Subject Reported Symptoms
ParticipantsµCor Wearers - Month 0uCor Wearers - Month 1uCor Wearers - Month 2uCor Wearers - Month 3
Severity of Dyspnea — Continuous211687
Severity of Dyspnea — Frequent132615343
Severity of Dyspnea — Seldom53554035
Severity of Dyspnea — None31312826
Severity of Dyspnea — No data882116134
Severity of Orthopnea — Continuous211586
Severity of Orthopnea — Frequent72351618
Severity of Orthopnea — Seldom62444024
Severity of Orthopnea — None82696663
Severity of Orthopnea — No data882115134
Severity of Fatigue — Continuous35221916
Severity of Fatigue — Frequent114624837
Severity of Fatigue — Seldom55504137
Severity of Fatigue — None33292221
Severity of Fatigue — No data882115134
SecondaryHospital Readmission Rate During the Study Period

During weekly phone calls and monthly office visits, subjects reported whether they experienced a new hospitalization since their last call/visit. An adjudication committee of physicians determined whether each hospitalization was due to HF or not.

Time frame:
3 months
Reported as:
Count of participants · Participants
Hospital Readmission Rate During the Study Period
ParticipantsµCor Wearers
Hospital Readmission Rate During the Study Period50
SecondaryHospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study

At the time of enrollment, subjects reported how many hospitalizations they experienced in the 90 days prior to enrollment. Results indicate the number of subjects who reported a hospitalization in this time window.

Time frame:
3 months
Reported as:
Count of participants · Participants
Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study
ParticipantsµCor Wearers
Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study206
SecondaryHospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study

At the time of enrollment, subjects reported how many hospitalizations they experienced in the 90 days prior to enrollment. Results indicate the median number of hospitalizations reported per subject in this time window.

Time frame:
3 months
Reported as:
Median · Hospitalizations
Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study
HospitalizationsµCor Wearers
Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study2 (1 to 2)
SecondaryMortality, Heart Failure Related Events, and Health Care Utilization Data at Six Months and One Year Post Enrollment

During weekly phone calls, monthly office visits, the 6-month phone call, and the 1-year phone call, subjects reported whether they experienced a hospitalization, ER visit, or unplanned doctor's office visit since the last call/visit. An adjudication committee of physicians determined whether each hospitalization was due to HF or not. On each subject's final date of study participation, their survival status was recorded.

Time frame:
6 months and 1 year
Reported as:
Number · Participants
Mortality, Heart Failure Related Events, and Health Care Utilization Data at Six Months and One Year Post Enrollment
ParticipantsSubjects at 6 MonthsSubjects at 1 Year
Mortality: Number of subjects reported dead2131
Heart Failure (HF) Related Events: Number of subjects with a hospital readmission for HF6877
Health Care Utilization: Number of subjects with a hospitalization for any reason127137
Health Care Utilization: Number of subjects with an Emergency Room visit for any reason109117
Health Care Utilization: Number of subjects with an unplanned doctor's office visit for any reason5462

Adverse events

Collected over 1 Year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
µCor Wearers35/257 (13.6%)1/257 (0.4%)149/257 (58%)
Most frequent serious events
Most frequent serious events
EventµCor Wearers
Procedural Complication to ECHOInjury, poisoning and procedural complications1/257
Most frequent other events
Most frequent other events
EventµCor Wearers
Skin IrritationSkin and subcutaneous tissue disorders146/257
DiscomfortProduct Issues3/257

Baseline characteristics

Age, Continuous
Age, Continuous(years)µCor Wearers
Mean65.7 ± 13.0
Sex: Female, Male
Sex: Female, Male(Participants)µCor Wearers
Female101
Male144
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)µCor Wearers
Ethnicity : Caucasian154
Ethnicity : Black or African American62
Ethnicity : Hispanic or Latin16
Ethnicity : Other5
Ethnicity : American Indian or Alaskan Native2
Ethnicity : Asian1
Ethnicity : Don't Know / No Response1
Ethnicity: Multiple Ethnicities4
Region of Enrollment
Region of Enrollment(participants)µCor Wearers
Austria13
United States221
Germany11
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)µCor Wearers
Mean33.6 ± 10.4
Blood Pressure (systolic)
Blood Pressure (systolic)(mmHg)µCor Wearers
Mean122.1 ± 19.3
Blood Pressure (diastolic)
Blood Pressure (diastolic)(mmHg)µCor Wearers
Mean71.5 ± 12.2
Respiration Rate
Respiration Rate(breaths per min)µCor Wearers
Mean18.1 ± 2.8

8 further baseline measures are reported on the registry.

07

Study locations

61 sites
  • Mobile Heart Specialists, PC
    Mobile, Alabama 36608, United States
  • University Hospital
    Mobile, Alabama 36617, United States
  • NEA Baptist Clinic
    Jonesboro, Arkansas 72405, United States
  • Cardiovascular Innovation and Research Center, Inc.
    Long Beach, California 90813, United States
  • Los Alamitos Cardiovascular
    Los Alamitos, California 90720, United States
  • Nova Clinical Research LLC
    Bradenton, Florida 34209, United States
  • South Palm Cardiovascular Research Institute
    Delray Beach, Florida 33446, United States
  • Holy Cross Medical Group
    Fort Lauderdale, Florida 33308, United States
  • The Cardiac and Vascular Institute Research Foundation
    Gainesville, Florida 32605, United States
  • Baptist Heart Specialists
    Jacksonville, Florida 32250, United States
  • The Heart Institute at Largo
    Largo, Florida 33770, United States
  • Mount Sinai Medical Center
    Miami Beach, Florida 33140, United States
  • Cardiovascular Institute of Central Florida
    Ocala, Florida 34471, United States
  • Northside Hospital
    Saint Petersburg, Florida 33709, United States
  • University of South Florida Dept of Cardiovascular Sciences
    Tampa, Florida 33609, United States
  • Cardiology Practice Tampa
    Tampa, Florida 33613, United States
  • Cardiovascular Consultants of South Georgia
    Thomasville, Georgia 31792, United States
  • Fox Valley Clinical Research Center
    Aurora, Illinois 60506, United States
  • The Loretto Hospital
    Chicago, Illinois 60644, United States
  • Chicago Medical Research LLC
    Hazel Crest, Illinois 60429, United States
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • Unity Point Health Cardiovascular Services
    Peoria, Illinois 61606, United States
  • DuPage Medical Group
    Winfield, Illinois 60190, United States
  • Grace Research LLC
    Bossier City, Louisiana 71111, United States
  • Clinical Trials of America, LLC
    Monroe, Louisiana 71201, United States
  • Clinical Trials of America, LLC
    West Monroe, Louisiana 71291, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Cardiology Institute of Michigan
    Flint, Michigan 48507, United States
  • Hennepen Healthcare Research Institute
    Minneapolis, Minnesota 55415, United States
  • Nebraska Heart Institute
    Grand Island, Nebraska 68803, United States
  • Nebraska Heart Institute
    Lincoln, Nebraska 68526, United States
  • University Medical Center of Southern Nevada
    Las Vegas, Nevada 89102, United States
  • New Jersey Heart
    Linden, New Jersey 07036, United States
  • AtlantiCare Regional Medical Center
    Pomona, New Jersey 08240, United States
  • Trinity Medical WNY
    Buffalo, New York 14215, United States
  • SJH Cardiology Associates
    Liverpool, New York 13088, United States
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
  • East Carolina Heart Institute
    Greenville, North Carolina 27834, United States
  • NC Heart & Vascular Research
    Raleigh, North Carolina 27607, United States
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
  • OUHSC
    Oklahoma City, Oklahoma 73104, United States
  • UMPC Hamot
    Erie, Pennsylvania 16550, United States
  • Lancaster General Hospital
    Lancaster, Pennsylvania 17602, United States
  • The Guthrie Clinic
    Sayre, Pennsylvania 18840, United States
  • Cardiology Consultants of Philadelphia
    Yardley, Pennsylvania 19067, United States
  • Palmetto Health Advanced Heart Health Center
    Columbia, South Carolina 29203, United States
  • The Jackson Clinic, PA
    Jackson, Tennessee 38301, United States
  • PharmaTex Research
    Amarillo, Texas 79106, United States
  • JPS Health Network
    Fort Worth, Texas 76104, United States
  • Texas Cardiovascular Institute
    Fort Worth, Texas 76104, United States
  • Northwest Houston Cardiology
    Houston, Texas 77070, United States
  • CardioVogage
    McKinney, Texas 75071, United States
  • Texas Institute of Cardiology
    McKinney, Texas 75071, United States
  • Riverside Hospital Inc.
    Newport News, Virginia 23601, United States
  • Chippenham Hospital
    Richmond, Virginia 23225, United States
  • Henrico Doctors Hospital
    Richmond, Virginia 23229, United States
  • Marshall Cardiology
    Huntington, West Virginia 25701, United States
  • Universitätsklinik für Innere Medizin II, Abteilung für Kardiologie
    Vienna, Austria
  • St. Vinzenz-Hospital; Akademisches Lehrkrankenhaus der Universität zu Köln, Innere Medizin III
    Cologne, Germany
  • Herzzentrum Leipzig GmbH
    Leipzig, 04289, Germany
  • Klinikum rechts der Isar - Technische Universität München, Klinik und Poliklinik für Innere Medizin I
    Munich, Germany
08

References and documents

Study documents

  • Protocol and statistical analysis plan · May 15, 2018

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

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03476187
Lead sponsor
Zoll Medical Corporation
Responsible party
Sponsor
First posted
Mar 23, 2018
Start date
Aug 17, 2018
Primary completion
Jan 8, 2024
Completion
Apr 9, 2024
Results posted
Aug 28, 2024
Last update
Jan 8, 2025

Study contacts

Steven J. Szymkiewicz, MD
study director · Zoll Medical Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
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