Study detail
Recruiting
ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)
Kestra Medical Technologies, Inc.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Not specified
Detailed 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
Interventions
- DeviceDefibrillation
External defibrillation from a wearable cardioverter defibrillator
Location
- University of Washington Medical CenterSeattle, Washington