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Lead
Zoll Medical Corporation
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
Clareo Health | LifeVest Trends Validation Protocol