N/A
Completed N=198
LifeVest Trends Validation Protocol
Source: ClinicalTrials.gov NCT02149290 ↗Enrolled (actual)
198
Serious AEs
2.5%
Results posted
Aug 2020
Primary outcomePrimary: Distance Traveled in Six Minute Walk Test — 306; 296 meters
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distance Traveled in Six Minute Walk Test |
306; 296 | — |
| SECONDARY Compliance With Completing 6MWT Through a Wearable Defibrillator. |
79 | — |
| SECONDARY Observe Compliance With Answering Questions Regarding Health Through a Wearable Defibrillator. |
93 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02149290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.