ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)

What this Trial Is About

This observational study focuses on patients at risk for sudden cardiac arrest who have been prescribed the ASSURE wearable cardioverter defibrillator (WCD). It uses real-world data collected through the ASSURE Patient Registry, including data recorded by the WCD and reviewed by clinical electrophysiology experts. The study aims to evaluate outcomes such as shock conversion rates and inappropriate shocks over a period of up to three years. Participants include adults prescribed the ASSURE WCD who have conditions like reduced left ventricular ejection fraction, recent heart attack, recent coronary revascularization, or new onset heart failure. Other participants may include those with implanted cardioverter defibrillators (ICDs) removed due to infection, postponed ICD implantation, or awaiting heart transplant. The study collects data passively from patients using the device as part of their medical care. During the study, researchers will analyze data on how well the WCD detects and treats arrhythmias, including overall and first shock conversion rates, and rates of inappropriate shocks. Participants are monitored through data recorded by the device and entered into the registry. The study duration extends up to three years, with ongoing data collection and evaluation to understand device performance and patient outcomes.

ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)