Clinical trial Recruiting at 1 site Observational Ages 18 and up

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.

More Sudden Cardiac Arrest trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment5179 (estimated)
SponsorKestra Medical Technologies, Inc.
Industry-sponsored
Locations1 site (Seattle, Washington)
StatusRecruiting
StartedNovember 20, 2021
Main results expectedOctober 1, 2025
Study endsOctober 1, 2025
Registry record updatedSeptember 2, 2025
Trial IDNCT05135403 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.