Kestra Medical Technologies, Ltd. announced primary results from the ASSURE®? WCD Clinical Evaluation Post-Approval Study (ACE-PAS), presented as a late-breaking science session at the American Heart Association (AHA) Scientific Sessions 2025 in New Orleans. ACE-PAS, the largest prospective real-world study of wearable defibrillators to date, confirmed the strong safety and effectiveness of the ASSURE WCD in clinical practice.
The study enrolled 21,612 patients across the United States. Key findings demonstrate consistent safety, effectiveness, and compliance in real-world use: Proven effectiveness: The primary effectiveness endpoint was achieved, with 100% successful conversion for ventricular tachycardia and fibrillation (VT/VF) events, surpassing the prespecified performance goal; Validated safety: The study met its primary safety endpoint, with an inappropriate-shock rate of 0.0065 per patient-month, below the prespecified performance goal and confirming a strong safety profile; Minimal false alarms; 94% of patients experienced no false positive shock alarms, ensuring confidence and comfort during wear; Critical protection; 2.6% of patients experienced at least one life-threatening VT/VF event within only a few months, highlighting the importance of protection in this vulnerable population; Additional clinically relevant arrhythmias revealed; The ASSURE system facilitated detection of high-rate atrial fibrillation in 4.2% of patients (35% previously undiagnosed) and severe bradycardia/asystole in 0.3%, enabling the potential of timely intervention; High compliance; Patients wore the device for a median of more than 23 hours per day, and one-third continued use beyond 90 days--highlighting its practicality in real-world, long-term care. The ASSURE WCD Clinical Evaluation Post- Approval Study (ACE- PAS) is a prospective, multicenter registry evaluating the use, safety, and effectiveness of the ASSURE Wearable Cardioverter Defibrillator in the prevention of sudden cardiac death.
The study enrolled 21,12 patients from November 2021 through July 2025 across the U.S. Primary endpoints were overall VT/VF shock conversion and inappropriate-shock rate.
