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ASSURE WCD Clinical Evaluation - Conversion Efficacy Study

NCT04132466 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-04-05

Study results available
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Summary

A multicenter single arm open label evaluation of the ASSURE Wearable Cardioverter Defibrillator (WCD) defibrillation waveform in adult cardiac patients

Conditions

  • Death, Sudden, Cardiac

Interventions

DEVICE

Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system

defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator

Sponsors & Collaborators

  • Regulatory and Clinical Research Institute Inc

    collaborator OTHER

  • Kestra Medical Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Marye Gleva, MD · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-25
Primary Completion
2020-03-19
Completion
2020-03-19
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04132466 on ClinicalTrials.gov