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HeartStart FRx Defibrillator Event Registry for Sudden Cardiac Arrest

This study is an observational registry looking at the HeartStart FRx Automated External Defibrillator (AED) when used for sudden cardiac arrest. It aims to check how well the device works and its safety in real-world situations. You could be included if you experienced a suspected circulatory arrest and had the HeartStart FRx AED with SMART PADS II applied. The study will look at how accurate the device's algorithm is, if a shock was delivered, and any unexpected side effects within one day of use. This registry collects information after the event and does not tell you how to use the device.

Study design
This is a multi-center, non-randomized, unblinded, observational registry. It plans to enroll 1400 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Information will be collected for up to 15 minutes after device placement for algorithm accuracy, and for 1 day regarding shock delivery and adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04250857

HeartStart FRx Defibrillator Event Registry

Recruiting
Not specifiedAll AgesObservational
Heartstream US LLC
~1,400 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:HeartStart FRX

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Algorithm accuracy
Measured over Up to 15 minutes after device placement
+3 more outcomes measured

Conditions

Sudden Cardiac Arrest

Explore related trials

Sudden Cardiac Arrest

Where it's being run

1 sites across 1 states
Pennsylvania1

Who to contact

Barb Fink
[email protected]
724-708-7048
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Algorithm accuracyUp to 15 minutes after device placement

    Algorithm performance as determined by adjudication of the wave form data as aligned with the device advisement.

  • Shock Delivery1 day

    Percentage of events where a shock was delivered when indicated.

  • Unexpected adverse events.1 day

    Frequency and severity of unexpected adverse events.

  • Unanticipated adverse device effects (UADE)1 day

    Unanticipated adverse device effects (UADE)