Evaluation of a wearable defibrillator for sudden cardiac arrest
Official title: ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)
Run by Kestra Medical Technologies, Inc. · NCT05135403 · Data updated 2026-11-12
This study is testing how well a wearable defibrillator works for people at risk of sudden cardiac arrest by looking at real-life data from patients using the device.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 5179 (estimated) |
| Sponsor | Kestra Medical Technologies, Inc. Industry-sponsored |
| Locations | 1 site (Seattle, Washington) |
| Status | Recruiting |
| Started | November 20, 2021 |
| Main results expected | October 1, 2025 |
| Study ends | October 1, 2025 |
| Registry record updated | September 2, 2025 |
| Trial ID | NCT05135403 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adult patients who have been prescribed the ASSURE wearable cardioverter defibrillator and have consented to participate in the registry.
✕Probably not a fit
Patients who do not meet the inclusion criteria, such as those not prescribed the ASSURE device, will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates the effectiveness of the ASSURE wearable cardioverter defibrillator through active surveillance of real-world data collected in the ASSURE Patient Registry. It focuses on analyzing outcomes based on data recorded by the device and annotated by clinical experts in electrophysiology. The study aims to gather insights into the device's performance and its impact on patient safety and health outcomes.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of wearable defibrillators and improve patient outcomes in sudden cardiac arrest situations.
How similar studies have gone: Other studies evaluating wearable defibrillators have shown promising results, indicating that this approach is supported by prior research.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of Washington Medical Center
Seattle, Washington, United States Recruiting
Study contacts
- Principal investigator: Jeanne Poole, M.D. — University of Washington
- Study coordinator: Kristin Eis, BSChE, MBA
- Email: kristin.eis@kestramedical.com
- Phone: 14256547596
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Registry for HeartStart HS1 Defibrillator performance and safety
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.