RecruitingNCT05135403
ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)
Sponsor
Kestra Medical Technologies, Inc.
Enrollment
5,179 participants
Start Date
Nov 20, 2021
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria2
- Adult patient prescribed the ASSURE wearable cardioverter defibrillator
- Provided written informed consent to participate in the ASSURE Patient Registry
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Interventions
DEVICEDefibrillation
External defibrillation from a wearable cardioverter defibrillator
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05135403
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