Trials / Recruiting
RecruitingNCT05135403
ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 5,179 (estimated)
- Sponsor
- Kestra Medical Technologies, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Defibrillation | External defibrillation from a wearable cardioverter defibrillator |
Timeline
- Start date
- 2021-11-20
- Primary completion
- 2025-10-01
- Completion
- 2025-10-01
- First posted
- 2021-11-26
- Last updated
- 2025-09-02
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05135403. Inclusion in this directory is not an endorsement.