Heart Failure Clinical Trial
LifeVest Trends Validation Protocol
Summary
This study will evaluate the accuracy of data on body position, daily activity, heart rate, 6-minute walk test, and a health survey collected by the wearable cardioverter defibrillator (WCD).
Full Description
This is a multi-center validation study of heart failure patients wearing the LifeVest WCD modified to collect data on body position, activity, heart rate, 6-minute walk test, and a health survey in order to evaluate data accuracy and patient interactions with the device.
Eligibility Criteria
Inclusion Criteria:
Symptomatic heart failure (i.e., New York Heart Association (NYHA) class II or higher)
Evidence of a prior Myocardial Infarction (MI) or dilated cardiomyopathy
Ejection fraction of 35% or less at the start of WCD use
Anticipated to need a WCD for three months or more
At least 18 years of age (over the legal age of providing consent)
Exclusion Criteria:
Use of an implantable cardioverter defibrillator (ICD), recent removal of an ICD, or planned use of an ICD within the next three months
Need for an assistive device for ambulation (wheelchair, walker, or cane)
Use of a unipolar pacemaker
Physical or mental conditions that prevent interaction with or wearing of the device
Advanced directive prohibiting resuscitation
Pregnancy
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There are 19 Locations for this study
Orange California, 92868, United States
Boca Raton Florida, 33432, United States
Lawrenceville Georgia, 30046, United States
Lexington Kentucky, 40503, United States
Flint Michigan, 48507, United States
Brooklyn New York, 11203, United States
Oklahoma City Oklahoma, 73120, United States
Chattanooga Tennessee, 37403, United States
Memphis Tennessee, 38104, United States
Virginia Beach Virginia, 23454, United States
Seattle Washington, 98122, United States
Charleston West Virginia, 25304, United States
Huntington West Virginia, 25702, United States
Graz , 8036, Austria
Bad Krozingen , 79189, Germany
Bad Nauheim , , Germany
Bonn , 53105, Germany
Coburg , 96450, Germany
Hamburg , , Germany
Köln , 50733, Germany
Villingen-Schwenningen , 78052, Germany
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