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.
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
705
Observe and compare the heart sound measurements recorded by the WCD
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.
Time frame: 3 months
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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
...and 23 more locations