Benefits of µCor in Ambulatory Decompensated Heart Failure (BMADHF)

December 16, 2024 updated by: Zoll Medical Corporation
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
257

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: µCor wearers
Wear the µCor device
Device: µCor
Monitor with µCor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Correlation of μCor Readings to Heart Failure Related Clinical Events
Time Frame: 3 months
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.
3 months
Correlation of µCor Readings to Heart Failure Related Clinical Events
Time Frame: 3 months

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
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Establishment of Rate of Occurrence of VT/VF Episodes and Arrhythmic Death in Subjects
Time Frame: Baseline, 90 days, 1 YR
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.
Baseline, 90 days, 1 YR
Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve
Time Frame: 3 months
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.
3 months
Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms
Time Frame: 3 months
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.
3 months
Frequency of Subject Reported Symptoms
Time Frame: 3 months
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.
3 months
Timing of Subject Reported Symptoms
Time Frame: 3 months
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.
3 months
Severity of Subject Reported Symptoms
Time Frame: 3 months
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.
3 months
Hospital Readmission Rate During the Study Period
Time Frame: 3 months
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.
3 months
Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study
Time Frame: 3 months
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.
3 months
Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study
Time Frame: 3 months
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.
3 months
Mortality, Heart Failure Related Events, and Health Care Utilization Data at Six Months and One Year Post Enrollment
Time Frame: 6 months and 1 year
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.
6 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zoll Medical Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Steven J. Szymkiewicz, MD, Zoll Medical Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 8, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 9, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 90D0182

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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