Evaluation of a wearable defibrillator for sudden cardiac arrest
ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)
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 |
|---|---|
| Enrollment | 5179 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kestra Medical Technologies, Inc. Industry-sponsored |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT05135403 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies evaluating wearable defibrillators have shown promising results, indicating that this approach is supported by prior research.
Eligibility criteria
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 this trial is running
Seattle, Washington
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.