An observational study in Sudden Cardiac Arrest, sponsored by Heartstream US LLC. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Heartstream US LLC · Observational
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.
314 studies on the registry are indexed under Death, Sudden, Cardiac; 80 are open to participants now.
This study's planned enrollment of 1,400 is above the median of 500 across 172 observational studies indexed under Death, Sudden, Cardiac.
Browse Death, Sudden, Cardiac studies →Heartstream US LLC is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Use of the HeartStart FRx AED is intended for the following populations in addition to adults: newborns, neonates, infant, children, and adolescents. It may also be used on pregnant women. Devices are located in public access spaces and with first responders around the world.
Exclusion Criteria:
All subject with suspected of a circulatory arrest for any cause.
Device: HeartStart FRX
Automated External Defibrillator
Algorithm accuracy
Algorithm performance as determined by adjudication of the wave form data as aligned with the device advisement.
Time frame: Up to 15 minutes after device placement
Shock Delivery
Percentage of events where a shock was delivered when indicated.
Time frame: 1 day
Unexpected adverse events.
Frequency and severity of unexpected adverse events.
Time frame: 1 day
Unanticipated adverse device effects (UADE)
Unanticipated adverse device effects (UADE)
Time frame: 1 day
Time Intervals
Measurements of device performance time intervals.
Time frame: 1 day
Device Preparation
Percentage of events where the device prepared to shock.
Time frame: 1 day
Shock Energy Delivered
The amount of shock energy delivered as measured in joules with each shock.
Time frame: 1 day
Pad Replacement
Frequency of pad replacement.
Time frame: 1 day
User
Frequency of user pressing the shock button.
Time frame: 1 day
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Heartstream US LLC