LifeVest Trends Validation Protocol

Completed

Brief 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).

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Trends-equipped LifeVest 4000	Trends-equipped LifeVest 4000	Subjects using the LifeVest 4000 modified to collect Trends data

Primary Outcome Measures

Name	Time	Method
Distance Traveled in Six Minute Walk Test	Three months	Relationship of the step count and distance measure of the LifeVest walk test in heart failure patients as compared to distance measure of medically supervised 6-minute walk test. Accuracy of activities, and body position in patients with heart failure as compared to patient diaries of activity and sleeping position.

Secondary Outcome Measures

Name	Time	Method
Observe Compliance With Answering Questions Regarding Health Through a Wearable Defibrillator.	Up to 12-14 Weeks of WCD use	Observe compliance with answering daily health survey.
Compliance With Completing 6MWT Through a Wearable Defibrillator.	Up to 12-14 Weeks of WCD use	Observe Compliance with completing weekly 6MWT

Locations (21): Orange County Heart Institute
🇺🇸
Orange, California, United States
Gwinnett Medical Center
🇺🇸
Lawrenceville, Georgia, United States
SUNY Downstate
🇺🇸
Brooklyn, New York, United States
Cardiology Institute of Michigan
🇺🇸
Flint, Michigan, United States
Lexington Cardiology Consultants
🇺🇸
Lexington, Kentucky, United States
Erlanger Clinical Research
🇺🇸
Chattanooga, Tennessee, United States
Methodist Healthcare Foundation
🇺🇸
Memphis, Tennessee, United States
St. Mary's Medical Center
🇺🇸
Huntington, West Virginia, United States
Universitats-Herzzentrum Freiburg - Bad Krozingen
🇩🇪
Bad Krozingen, Germany
Kerckhoff-Klinik
🇩🇪
Bad Nauheim, Germany
Klinikum Coburg
🇩🇪
Coburg, Germany
Medizinische Klinik & Poliklinik II - Kardiologie
🇩🇪
Bonn, Germany
Department für Herzinsuffizienz und Devicetherap
🇩🇪
Hamburg, Germany
St. Vinzenz Hospital
🇩🇪
Köln, Germany
Klinik für Innere Medizin III
🇩🇪
Villingen-Schwenningen, Germany
Klinische Abteilung für Kardiologie
🇦🇹
Graz, Austria
Cardiac Arrhythmia Service
🇺🇸
Boca Raton, Florida, United States
VA Beach General
🇺🇸
Virginia Beach, Virginia, United States
Swedish Medical Center
🇺🇸
Seattle, Washington, United States
CAMC
🇺🇸
Charleston, West Virginia, United States
Oklahoma Heart Hospital
🇺🇸
Oklahoma City, Oklahoma, United States