LifeVest Trends Validation Protocol

Study Overview
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Brief Summary
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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
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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.

Official Title
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LifeVest Trends Validation Protocol

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Trends-equipped LifeVest 4000


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trends-equipped LifeVest 4000<br>Subjects using the LifeVest 4000 modified to collect Trends data | Device: Trends-equipped LifeVest 4000<br>* LifeVest 4000 monitors patients for VT/VF, notifies the patient if VT/VF occurs, and instructs them to press response buttons. In unresponsive patients, LifeVest delivers defibrillation therapy. Trends modifications for heart failure monitoring include: body position data collection; heart rate measurements, activity data collection; ability to perform a health survey; ability to guide patients through a walk test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Traveled in Six Minute Walk Test | 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. | Three months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Six minute walk test