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.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Philips
RECRUITINGMonroeville, Pennsylvania, 15146, United States
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