NCT05135403Recruiting

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

Kestra Medical Technologies, Inc.

Start Date

11/20/2021

Completion Date

10/1/2025

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Adult patient prescribed the ASSURE wearable cardioverter defibrillator * Provided written informed consent to participate in the ASSURE Patient Registry Exclusion Criteria: * Patients who do not meet the Inclusion criteria

Interventions

DEVICE

Defibrillation

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Conditions

Sudden Cardiac Arrest

Locations

University of Washington Medical Center

Seattle, Washington 98033

United States

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