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HeartStart FRx Defibrillator Event Registry

Who can join

All ages · All sexes

Inclusion Criteria:

* 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

Exclusion Criteria:

* AED or pad use other than the HeartStart FRx AED with electrodes : HeartStart SMART PADS II
* AED used for training purposes.

About the study

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.

What is being tested

• HeartStart FRX (device)

Sponsor: Heartstream US LLC · Participants: 1,400 · Started: Nov 4, 2019

Contact the study team

• Barb Fink · Phone: 724-708-7048

Official record on ClinicalTrials.gov — NCT04250857

Locations in the U.S.

Conditions

• Cardiac Sudden Death

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.