Clinical Trials in the USA / NCT05135403
Recruiting
Observational
ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)
NCT05135403 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Sudden Cardiac Arrest
Investigational drug(s) / intervention(s)
Defibrillation
Defibrillation: External defibrillation from a wearable cardioverter defibrillator
Study 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.
Eligibility
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
Primary outcome measure(s)
- Overall shock conversion rate — Up 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 month — Up to 3 years
Total inappropriate shocks/cumulative months of WCD use for all patients ≤ 0.0075
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Washington Medical Center | Seattle | Washington | Recruiting |
Other trials for the same condition
HeartStart HS1 Defibrillator* Event Registry
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HeartStart FRx Defibrillator Event Registry
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05135403 on ClinicalTrials.gov ↗ ← All trials in the USA