HeartStart FRx Defibrillator Event Registry
NCT: NCT04250857 · RECRUITING
Brief Summary
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.
Frequently Asked Questions
What is HeartStart FRx Defibrillator Event Registry?
HeartStart FRx Defibrillator Event Registry is a clinical trial registered under NCT04250857. Current status: RECRUITING.
What is the status of NCT04250857?
The current status of NCT04250857 (HeartStart FRx Defibrillator Event Registry) is: RECRUITING.
When did HeartStart FRx Defibrillator Event Registry start?
HeartStart FRx Defibrillator Event Registry started on 2019-11-04.
Related Devices
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.