Heart Sounds Registry
HEARIT-Reg
1 other identifier
observational
705
4 countries
33
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
Typical duration for all trials
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 5, 2017
CompletedFirst Submitted
Initial submission to the registry
June 14, 2017
CompletedFirst Posted
Study publicly available on registry
June 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2021
CompletedApril 23, 2021
April 1, 2021
2.7 years
June 14, 2017
April 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
Observe and compare the heart sound measurements recorded by the WCD
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
MD Strategies Research Center
National City, California, 91950, United States
JFK Medical Center
Atlantis, Florida, 33462, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Northside Hospital / Heart Institute
St. Petersburg, Florida, 33709, United States
Carle Foundation Hospital
Urbana, Illinois, 61801, United States
FRANCISCAN HEALTH Indianapolis
Indianapolis, Indiana, 46237, United States
Cardiovascular Institute of Michigan
Clinton Township, Michigan, 48038, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439, United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
Michigan CardioVascular Institute
Saginaw, Michigan, 48601, United States
Virtua The Cardiology Group
Moorestown, New Jersey, 08057, United States
Virtua The Cardiology Group
Voorhees Township, New Jersey, 08043, United States
Saratoga Clinical Research
Saratoga Springs, New York, 12866, United States
MD First Research
Anderson, South Carolina, 29625, United States
McLeod Regional
Florence, South Carolina, 29506, United States
Chippenham Medical Center
Richmond, Virginia, 23225, United States
West Virginia University Research
Morgantown, West Virginia, 26506, United States
Medizinische Universität Graz
Graz, Austria
Charité Berlin Benjamin Franklin
Berlin, Germany
Herzzentrum Dresden
Dresden, Germany
Uni Erlangen
Erlangen, 91054, Germany
Universitätsklinikum Frankfurt
Frankfurt, Germany
Albertinenkrankenhaus HamburgKardiologie Albertinen-Krankenhaus
Hamburg, Germany
Asklepios St. Georg Hamburg
Hamburg, Germany
Sana Klinikum Hof,
Hof, Germany
Krankenhaus und MVZ Maria-Hilf Stadtlohn GmbH
Stadtlohn, Germany
University of Würzburg, Medizinische Klinik und Poliklinik I
Würzburg, Germany
American Heart of Poland S.A.
Chrzanów, 32-500, Poland
Wissmed Gdanskie Centrum
Gdansk, 80-175, Poland
Klinika Elektrokardiologii Uniwersytetu Medycznego w Lodzi
Lodz, 92-213, Poland
Spzoz Msw
Rzeszów, 35-111, Poland
EMED Centrum Uslug Medycznych
Rzeszów, 35-205, Poland
Wojewodzki Szpital Zespolony
Torun, 87-100, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Steven J. Szymkiewicz, MD
Zoll Medical Corporation
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2017
First Posted
June 29, 2017
Study Start
June 5, 2017
Primary Completion
January 30, 2020
Study Completion
March 16, 2021
Last Updated
April 23, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share