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Recruiting NCT05135403
ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)
Trial Parameters
Condition Sudden Cardiac Arrest
Sponsor Kestra Medical Technologies, Inc.
Study Type OBSERVATIONAL
Phase N/A
Enrollment 5,179
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-11-20
Completion 2025-10-01
Interventions
Defibrillation
Brief 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
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