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ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)

NCT05135403 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5179

Last updated 2025-09-02

No results posted yet for this study

Summary

Active surveillance study using real-world data collected in the ASSURE Patient Registry. Outcome measures are based on analysis of ASSURE Registry data including data recorded by the WCD then annotated by clinical experts in electrophysiology.

Conditions

  • Sudden Cardiac Arrest

Interventions

DEVICE

Defibrillation

External defibrillation from a wearable cardioverter defibrillator

Sponsors & Collaborators

  • Kestra Medical Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeanne Poole, M.D. · University of Washington

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-20
Primary Completion
2025-10-01
Completion
2025-10-01
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 NCT05135403 on ClinicalTrials.gov