An observational study in Sudden Cardiac Arrest, sponsored by Kestra Medical Technologies, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-02.
Sponsored by Kestra Medical Technologies, Inc. · Observational
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.
314 studies on the registry are indexed under Death, Sudden, Cardiac; 80 are open to participants now.
This study's planned enrollment of 5,179 is above the median of 500 across 172 observational studies indexed under Death, Sudden, Cardiac.
Browse Death, Sudden, Cardiac studies →Kestra Medical Technologies, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The ASSURE Wearable Cardioverter Defibrillator (WCD) system is indicated for adult patients who are at risk or at perceived risk of sudden cardiac arrest (SCA) and are not immediate candidates for, or refuse, an implantable defibrillator.
Exclusion Criteria:
Patient prescribed the ASSURE WCD who have also consented to participate in the ASSURE Patient Registry. Patients include those with reduced left ventricular ejection fraction (LVEF) and recent myocardial infarction, recent coronary revascularization, or new onset heart failure (HF) to allow for optimization of medical therapy and re-evaluation of cardiac function. Additional indications include ICD explant due to infection, postponed ICD implant, and pending heart transplant.
Device: Defibrillation
External defibrillation from a wearable cardioverter defibrillator
Overall shock conversion rate
Percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) successfully converted with one or more shocks ≥ 89.0%
Time frame: Up to 3 years
Inappropriate shocks per patient month
Total inappropriate shocks/cumulative months of WCD use for all patients ≤ 0.0075
Time frame: Up to 3 years
First shock conversion rate
Percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) converted with a single shock. (report only)
Time frame: Up to 3 years
Inappropriate shock rate
Percent of patients who experience at least one inappropriate shock (report only)
Time frame: Up to 3 years
Appropriate shock rate per month
Number of appropriate shocks/cumulative months of WCD use
Time frame: Up to 3 years
Appropriate shock rate
Percent of patients who experience at least one appropriate shock
Time frame: Up to 3 years
Total Shocks delivered
Number of shocks delivered
Time frame: Up to 3 years
Shocks diverted
Number of shocks diverted by patients
Time frame: Up to 3 years
False positive shock alarm rate
Number of false positive shock alarms/cumulative WCD use
Time frame: Up to 3 years
True positive shock alarm rate
Number of true positive shock alarms/cumulative WCD use
Time frame: Up to 3 years
Adverse events
Adverse events related to use of the WCD
Time frame: Up to 3 years
Average daily device use
Average daily use of the WCD in hours per day
Time frame: Up to 3 years
Cumulative device use
Cumulative device use in days
Time frame: Up to 3 years
Plan to share: No
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Kestra Medical Technologies, Inc.