ASSURE WCD Clinical Evaluation for Sudden Cardiac Arrest
This study, called ACE-PAS, is looking at how well the ASSURE wearable cardioverter defibrillator (WCD) works in real-world settings for people at risk of sudden cardiac arrest. The WCD is a device worn on the body that can deliver an electrical shock (defibrillation) to restart the heart if it stops suddenly. Researchers want to see how often the device successfully delivers a shock when needed (overall shock conversion rate) and how often it delivers a shock when it's not needed (inappropriate shocks). You can join if you are an adult who has been prescribed the ASSURE WCD and agree to participate in the ASSURE Patient Registry. The study is currently collecting information from over 5,000 participants, but its current recruitment status is unclear.
- Study design
- This is an observational study collecting real-world data from over 5,000 participants using the ASSURE wearable cardioverter defibrillator.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 3 years to measure the study's main outcomes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jeanne Poole, M.D. · PRINCIPAL_INVESTIGATOR · University of Washington
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Overall shock conversion rateUp to 3 years
Percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) successfully converted with one or more shocks ≥ 89.0%
- Inappropriate shocks per patient monthUp to 3 years
Total inappropriate shocks/cumulative months of WCD use for all patients ≤ 0.0075