Last updated on July 2019

Heart Sounds Registry


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT03203629

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Uni Erlangen

Erlangen, Germany
8.68miles
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