HeartStart FRx Defibrillator Event Registry

This post market clinical follow-up study is a multi-center, non-randomized, unblinded, observational registry of the performance of the FRx Automated external defibrillator (AED) used in conjunction with electrodes with or without use of the infant/child key. The registry is focused only on on post-event data collection and does not prescribe any device usage. This registry has several safeguards in place to prevent against selections bias, including enrollment of all participants who have pads placed. This registry will evaluate the safety and verify the clinical performance of the device in relation to its claims, when used in accordance with the Device Manual.

NCT Number	NCT04250857
Lead Sponsor	Heartstream US LLC
Conditions	Sudden Cardiac Arrest
Enrollment	1,400 participants
Start Date	2019-11-04
Primary Completion	2030-12-31 (estimated)
Study Completion	2030-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-11