Heart Sounds Registry (HEARIT-Reg)

April 22, 2021 updated by: Zoll Medical Corporation

Heart Sounds Registry In Patients Using The Wearable Cardioverter Defibrillator (HEARIT-Registry) Study Protocol

To conduct a prospective, observational study to evaluate the non-interventional feasibility of using heart sounds measurements recorded by the LifeVest® Wearable Cardioverter Defibrillator (WCD) for monitoring clinical evidence of heart failure decompensation.

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

To conduct a prospective, observational study to evaluate the non-interventional feasibility of using heart sounds measurements recorded by the LifeVest® Wearable Cardioverter Defibrillator (WCD) for monitoring clinical evidence of heart failure decompensation.

Participants will be adult (age ≥ 18 years) heart failure patients with an ejection fraction (EF) ≤ 35% and eligible to wear the WCD for at least 3 months.

An FDA-approved WCD will be prescribed for at least 3 months of use after hospital discharge.

This is a multi-center, prospective, observational study.

The study will enroll a total of 300 subjects, anticipating that at least 250 subjects will complete the study. A maximum of 50 sites will enroll patients into the study.

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.
Observational

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.
705

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
      • Graz, Austria
        • Medizinische Universität Graz
  • Germany
      • Berlin, Germany
        • Charité Berlin Benjamin Franklin
      • Dresden, Germany
        • Herzzentrum Dresden
      • Erlangen, Germany, 91054
        • Uni Erlangen
      • Frankfurt, Germany
        • Universitätsklinikum Frankfurt
      • Hamburg, Germany
        • Albertinenkrankenhaus HamburgKardiologie Albertinen-Krankenhaus
      • Hamburg, Germany
        • Asklepios St. Georg Hamburg
      • Hof, Germany
        • Sana Klinikum Hof,
      • Stadtlohn, Germany
        • Krankenhaus und MVZ Maria-Hilf Stadtlohn GmbH
      • Würzburg, Germany
        • University of Würzburg, Medizinische Klinik und Poliklinik I
  • Poland
      • Chrzanów, Poland, 32-500
        • American Heart of Poland S.A.
      • Gdansk, Poland, 80-175
        • Wissmed Gdanskie Centrum
      • Lodz, Poland, 92-213
        • Klinika Elektrokardiologii Uniwersytetu Medycznego w Lodzi
      • Rzeszow, Poland, 35-111
        • Spzoz Msw
      • Rzeszow, Poland, 35-205
        • EMED Centrum Uslug Medycznych
      • Torun, Poland, 87-100
        • Wojewodzki Szpital Zespolony
  • United States
    • California
      • National City, California, United States, 91950
        • MD Strategies Research Center
    • Florida
      • Atlantis, Florida, United States, 33462
        • JFK Medical Center
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
      • Saint Petersburg, Florida, United States, 33709
        • Northside Hospital / Heart Institute
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Carle Foundation Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Franciscan Health Indianapolis
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • Cardiovascular Institute of Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Genesys Regional Medical Center
      • Lansing, Michigan, United States, 48912
        • Sparrow Clinical Research Institute
      • Saginaw, Michigan, United States, 48601
        • Michigan Cardiovascular Institute
    • New Jersey
      • Moorestown, New Jersey, United States, 08057
        • Virtua The Cardiology Group
      • Voorhees, New Jersey, United States, 08043
        • Virtua The Cardiology Group
    • New York
      • Saratoga Springs, New York, United States, 12866
        • Saratoga Clinical Research
    • South Carolina
      • Anderson, South Carolina, United States, 29625
        • MD First Research
      • Florence, South Carolina, United States, 29506
        • McLeod Regional
    • Virginia
      • Richmond, Virginia, United States, 23225
        • Chippenham Medical Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Research

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be adult (age ≥ 18 years) heart failure patients with an ejection fraction (EF) ≤ 35% and eligible to wear the WCD for at least 3 months.

Description

Inclusion Criteria:

  • Patients who are prescribed the WCD ≤ 10 days post-discharge after hospitalization with Heart Failure (HF), with and ischemic or non-ischemic cardiomyopathy.
  • Patients who have an ejection fraction (EF) ≤ 35% at the time of WCD prescription.
  • Patients are anticipated to wear the WCD for at least 3 months.
  • The subject must be 18 years of age or older on the day of screening.

Exclusion Criteria:

  • Patients with pacemakers, an implanted cardioverter defibrillator (ICD), or a cardiac resynchronization therapy device.
  • Patients waiting for heart transplant.
  • Patients with known evidence of atrial fibrillation on their most recent ECG recording.
  • Patients currently hospitalized for acute myocardial infarction.
  • Patients with a planned revascularization within 30 days of screening.
  • Patients who are self-reporting to be pregnant.
  • Patients participating in another clinical study.
  • Patients not expected to live longer than 1 year.
  • For patients in the United States, those who are unable or unwilling to provide written informed consent in English.
  • For patients in Europe, those who are unable or unwilling to provide written informed consent in their country specific language or English.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
Observe the changes in the heart sounds measurement
Time Frame: 3 months
Observe the changes in the heart sounds measurement (recorded by the WCD) with clinical evidence of heart failure decompensation during the three month WCD treatment period.
3 months

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.
June 5, 2017

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 30, 2020

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.
March 16, 2021

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).
June 14, 2017

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.
June 27, 2017

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.
June 29, 2017

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.
April 23, 2021

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.
April 22, 2021

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.
April 1, 2021

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.
  • 90D0164

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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