HeartStart FRx Defibrillator Event Registry

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04250857
Study type	Observational [Patient Registry]
Source	Philips Clinical & Medical Affairs Global
Contact	Barb Fink
Phone	724-708-7048
Email	barb.fink@philips.com
Status	Recruiting
Phase
Start date	November 4, 2019
Completion date	December 2027

View Details

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