Monitoring Safety and Performance of the HeartStart FRx Automated External Defibrillator in Sudden Cardiac Arrest Cases

What this Trial Is About

This observational registry study focuses on individuals who experienced a sudden cardiac arrest and had the HeartStart FRx Automated External Defibrillator AED used with HeartStart SMART PADS II electrodes. The study aims to monitor the safety and clinical performance of the AED device when used according to the device manual. It is a multi-center, non-randomized, and unblinded registry designed to collect post-event data without directing how the device is used. Participants include all who had the HeartStart FRx AED pads applied during a suspected circulatory arrest, regardless of whether a shock was delivered. The registry collects data related to device performance, including algorithm accuracy up to 15 minutes after device placement, shock delivery, and any unexpected or unanticipated adverse device effects within one day of use. Additional measures include timing intervals, device preparation, energy delivered, pad replacement, and user information. During the study, data are gathered following device use without altering standard care. Researchers record various safety and performance outcomes related to the AEDs use in sudden cardiac arrest cases. The study collects information shortly after the event, mainly within one day, ensuring comprehensive monitoring. The total participation duration varies depending on when the device was applied and the follow-up data collection, with study completion extending through 2030.

HeartStart FRx Defibrillator Event Registry