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RECRUITING
NCT05135403

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

Sponsor: Kestra Medical Technologies, Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

5179

Start Date

2021-11-20

Completion Date

2025-10-01

Last Updated

2025-09-02

Healthy Volunteers

Not specified

Interventions

DEVICE

Defibrillation

External defibrillation from a wearable cardioverter defibrillator

Locations (1)

University of Washington Medical Center

Seattle, Washington, United States