Heart Sounds Registry (HEARIT-Reg)

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: Completed
• Conditions: Heart Failure; With Decompensation
• Intervention / Treatment: Device: Wearable Cardioverter Defibrillator (WCD)

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: Observational
• Enrollment (Actual): 705

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observe the changes in the heart sounds measurement	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

• Sponsor: Zoll Medical Corporation
• Investigators: Study Director: Steven J. Szymkiewicz, MD, Zoll Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2017
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): March 16, 2021

Study Registration Dates

• First Submitted: June 14, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (Actual): June 29, 2017

Study Record Updates

• Last Update Posted (Actual): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID 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