LifeVest Trends Validation Protocol

LifeVest Trends Validation Protocol

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