Heart Sounds Registry
- Conditions
- Heart Failure; With Decompensation
- Registration Number
- NCT03203629
- Lead Sponsor
- Zoll Medical Corporation
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 705
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Observe the changes in the heart sounds measurement 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
American Heart of Poland S.A.
🇵🇱Chrzanów, Poland
JFK Medical Center
🇺🇸Atlantis, Florida, United States
Northside Hospital / Heart Institute
🇺🇸Saint Petersburg, Florida, United States
Medizinische Universität Graz
🇦🇹Graz, Austria
Uni Erlangen
🇩🇪Erlangen, Germany
Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
Sparrow Clinical Research Institute
🇺🇸Lansing, Michigan, United States
Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Virtua The Cardiology Group
🇺🇸Voorhees, New Jersey, United States
MD First Research
🇺🇸Anderson, South Carolina, United States
West Virginia University Research
🇺🇸Morgantown, West Virginia, United States
MD Strategies Research Center
🇺🇸National City, California, United States
Cardiovascular Institute of Michigan
🇺🇸Clinton Township, Michigan, United States
Genesys Regional Medical Center
🇺🇸Grand Blanc, Michigan, United States
Saratoga Clinical Research
🇺🇸Saratoga Springs, New York, United States
Michigan CardioVascular Institute
🇺🇸Saginaw, Michigan, United States
McLeod Regional
🇺🇸Florence, South Carolina, United States
Charité Berlin Benjamin Franklin
🇩🇪Berlin, Germany
Herzzentrum Dresden
🇩🇪Dresden, Germany
Sana Klinikum Hof,
🇩🇪Hof, Germany
Krankenhaus und MVZ Maria-Hilf Stadtlohn GmbH
🇩🇪Stadtlohn, Germany
Asklepios St. Georg Hamburg
🇩🇪Hamburg, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Albertinenkrankenhaus HamburgKardiologie Albertinen-Krankenhaus
🇩🇪Hamburg, Germany
University of Würzburg, Medizinische Klinik und Poliklinik I
🇩🇪Würzburg, Germany
Wissmed Gdanskie Centrum
🇵🇱Gdansk, Poland
Klinika Elektrokardiologii Uniwersytetu Medycznego w Lodzi
🇵🇱Lodz, Poland
EMED Centrum Uslug Medycznych
🇵🇱Rzeszow, Poland
Spzoz Msw
🇵🇱Rzeszow, Poland
Wojewodzki Szpital Zespolony
🇵🇱Torun, Poland
FRANCISCAN HEALTH Indianapolis
🇺🇸Indianapolis, Indiana, United States
Chippenham Medical Center
🇺🇸Richmond, Virginia, United States