LifeVest Trends Validation Protocol

Status:	Completed
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	2/22/2018
Start Date:	February 2014
End Date:	December 2017

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).

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.

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

We found this trial at

sites

Cardiac Arrhythmia Service

1200 North Federal Highway
Boca Raton, Florida 33432

from

Boca Raton, FL