HeartStart FRx Defibrillator Event Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPhilips Clinical & Medical Affairs Global

About this trial

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.

Eligibility criteria

Qualifiers

Subjects accepted into the study must: have been suspected of a circulatory arrest for any cause

Have had HeartStart FRx AED with electrodes: HeartStart SMART PADS II applied to their body and powered up, regardless of whether a defibrillation shock was delivered

Disqualifiers

AED or pad use other than the HeartStart FRx AED with electrodes : HeartStart SMART PADS II

AED used for training purposes.

Trial design

Treatments tested in this trial

  • HeartStart FRX

Treatment groups

1,400 Participants
are divided into 1 treatment group