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LifeVest Trends Validation Protocol

NCT02149290 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 198

Last updated 2020-08-31

Study results available
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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).

Conditions

Interventions

DEVICE

Trends-equipped LifeVest 4000

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

Sponsors & Collaborators

  • Zoll Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Steven J Szymkiewicz, MD · Zoll Medical Corporation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2017-12-31
Completion
2017-12-31
FDA Device
Yes

Countries

  • United States
  • Austria
  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02149290 on ClinicalTrials.gov