CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 198 enrolled
Drug / intervention
Trends-equipped LifeVest 4000device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02149290
NCT02149290N/ACompleted
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LifeVest Trends Validation Protocol

Zoll Medical Corporation·observational·Posted May 29, 2014·Updated Aug 31, 2020

In Brief

An observational study evaluating Trends-equipped LifeVest 4000 for Heart Failure. Completed, enrolled 198 participants across 21 sites in 3 countries.

Detailed 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).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesAustria, Germany, United States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 29, 2014
Enrollment StartFeb 1, 2014
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 12.1 years ago

Interventions

Trends-equipped LifeVest 4000device

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