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Can a Pocket-Sized defibrillator deliver when it counts?

NCT ID NCT04250857

Knowledge-focused Sponsor: Heartstream US LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2019

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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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.

Sudden cardiac arrest

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Philips

    RECRUITING

    Monroeville, Pennsylvania, 15146, United States

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