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LifeVest Wearable Cardioverter Defibrillator WEARIT-III Registry

NCT02700880 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2019-03-28

No results posted yet for this study

Summary

The WEARIT-III registry enrolls subjects with ischemic cardiomyopathy and heart failure (including NYHA II, III, IV and an ejection fraction ≤ 35%) who wear a medically prescribed ZOLL LifeVest Wearable Defibrillator. The primary objective of the WEARIT-III Registry is to prospectively document the clinical course of high-risk cardiac patients with heart failure and ischemic cardiomyopathy prescribed with Wearable Cardioverter Defibrillator (WCD), such as left ventricular function recovery, arrhythmia, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT), Left Ventricular Assist Device (LVAD), heart transplantation, and to assess the benefit of WCD in heart failure patients with ischemic cardiomyopathy.

Conditions

  • Ischemic Heart Failure

Interventions

DEVICE

LifeVest

LifeVest 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.

Sponsors & Collaborators

  • University of Rochester

    collaborator OTHER

  • Zoll Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Valentina Kutyifa, MD,PhD · University of Rochester

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2018-02-28
Completion
2019-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT02700880 on ClinicalTrials.gov