Registry Study Evaluating Safety and Performance of HeartStart HS1 Automated External Defibrillator in Sudden Cardiac Arrest

What this Trial Is About

This research aims to gather and evaluate post-event data on the safety and performance of the HeartStart HS1 Defibrillator device, including the HeartStart OnSite and HeartStart Home models. The study focuses on how the device delivers energy during use and its effectiveness in treating sudden cardiac arrest in the population intended for its commercial use. It also looks at the relationship between device performance and the type of electrode pads used. Participants in this study have suspected circulatory arrest of any cause and have had the HeartStart HS1 Defibrillator applied to their body with specific Philips electrode pads. Data collection occurs during device placement, up to 15 minutes, assessing shock energy delivered in both pediatric and adult populations, shock advisory algorithm performance, detection of shockable rhythms, and defibrillation success. The study also monitors secondary factors such as adverse events, device self-tests, battery status, pad replacement notifications, and CPR guidance and activity. Participants involvement includes being monitored during the use of the defibrillator device, with data gathered from the devices logged information during the event. Researchers measure key outcomes related to shock delivery, device operation, and safety within a short timeframe during device application. The study follows patients until the primary completion date in 2030, focusing on collecting real-world data to confirm device performance and safety in actual use.

HeartStart HS1 Defibrillator* Event Registry