Heart Sounds Registry

Completed

Conditions studied: Heart Failure; With Decompensation

In brief

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.

Key facts

Study ID

NCT03203629

Run by

Zoll Medical Corporation

People needed

705

Starts

2017-06-05

Expected to finish

2021-03-16

Last updated by the study team

2021-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• MD Strategies Research Center — National City, California, United States
• JFK Medical Center — Atlantis, Florida, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Northside Hospital / Heart Institute — St. Petersburg, Florida, United States
• Carle Foundation Hospital — Urbana, Illinois, United States
• FRANCISCAN HEALTH Indianapolis — Indianapolis, Indiana, United States
• Cardiovascular Institute of Michigan — Clinton Township, Michigan, United States
• Genesys Regional Medical Center — Grand Blanc, Michigan, United States
• Sparrow Clinical Research Institute — Lansing, Michigan, United States
• Michigan CardioVascular Institute — Saginaw, Michigan, United States
• Virtua The Cardiology Group — Moorestown, New Jersey, United States
• Virtua The Cardiology Group — Voorhees Township, New Jersey, United States
• Saratoga Clinical Research — Saratoga Springs, New York, United States
• MD First Research — Anderson, South Carolina, United States
• McLeod Regional — Florence, South Carolina, United States
• Chippenham Medical Center — Richmond, Virginia, United States
• West Virginia University Research — Morgantown, West Virginia, United States
• Medizinische Universität Graz — Graz, Austria
• Charité Berlin Benjamin Franklin — Berlin, Germany
• Herzzentrum Dresden — Dresden, Germany
• Uni Erlangen — Erlangen, Germany
• Universitätsklinikum Frankfurt — Frankfurt, Germany
• Albertinenkrankenhaus HamburgKardiologie Albertinen-Krankenhaus — Hamburg, Germany
• Asklepios St. Georg Hamburg — Hamburg, Germany
• Sana Klinikum Hof, — Hof, Germany

Full record on ClinicalTrials.gov

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