Can a Pocket-Sized defibrillator deliver when it counts?

NCT ID NCT04250857

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This study is a registry that tracks what happens when the HeartStart FRx, an automated external defibrillator (AED), is used on people suspected of having a cardiac arrest. The goal is to verify the device's safety and performance in real-world situations, such as whether it accurately analyzes heart rhythms and delivers a shock when needed. The registry includes about 1,400 people who had the device's pads placed on them, regardless of whether a shock was given. By collecting this event data, researchers hope to confirm the device works as intended when used according to the manual.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
HeartStart FRx automated external defibrillator (AED) with SMART PADS II electrodes
What this could lead to
If the device performs as intended, this could reinforce confidence in using the HeartStart FRx to treat sudden cardiac arrest in real-world settings.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results depend on how the device is used and the quality of event data collected.

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Conditions

The condition(s) this trial relates to.

Death, Sudden, Cardiac sudden cardiac arrest

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Philips

    RECRUITING

    Monroeville, Pennsylvania, 15146, United States

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