Clinical trial Recruiting at 1 site Observational

Registry for the HeartStart FRx Defibrillator's performance in cardiac arrest cases

Official title: HeartStart FRx Defibrillator Event Registry

Run by Heartstream US LLC · NCT04250857 · Data updated 2026-11-12

This study is collecting information on how well the HeartStart FRx defibrillator works during cardiac arrests to see if it lives up to its promises.

More Sudden Cardiac Arrest trials

Quick facts

Study typeObservational
SexAll
Enrollment1400 (estimated)
SponsorHeartstream US LLC
Industry-sponsored
Locations1 site (Monroeville, Pennsylvania)
StatusRecruiting
StartedNovember 4, 2019
Main results expectedDecember 31, 2030
Study endsDecember 31, 2030
Registry record updatedAugust 11, 2026
Trial IDNCT04250857 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this registry are individuals suspected of experiencing a circulatory arrest who had the HeartStart FRx AED applied.

Probably not a fit

Patients who used a different AED or those who were involved in training scenarios will not benefit from this registry.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry collects post-event data on the performance of the HeartStart FRx Automated External Defibrillator (AED) used during suspected circulatory arrests. It includes participants who had the device applied, regardless of whether a shock was delivered, ensuring a comprehensive evaluation of the device's safety and clinical performance. The study employs safeguards to minimize selection bias by enrolling all eligible subjects who had the AED pads placed. The registry aims to verify the device's claims as outlined in the Device Manual.

Why it matters

Potential benefit: If successful, this registry could enhance the understanding of the HeartStart FRx AED's effectiveness, potentially improving outcomes for patients experiencing sudden cardiac arrest.

How similar studies have gone: While this registry focuses on a specific device, similar observational studies have successfully evaluated AED performance in the past, indicating a precedent for this type of research.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Philips
    Monroeville, Pennsylvania, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.