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Can a software update make heart monitors read ECGs more clearly?

NCT ID NCT05636332

Diagnosis 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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing a software update for the Philips HeartStart Intrepid monitor, a device that records 12-lead electrocardiograms (ECGs) to check heart rhythms. The study enrolls people from 29 days to 89 years old who are willing to have ECG tracings taken. The goal is to see whether the updated software can reliably capture diagnostic-quality 12-lead ECG readings and whether any unexpected device effects occur.

What this could mean

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

Active substance
12-lead electrocardiogram monitoring with the Philips HeartStart Intrepid monitor/defibrillator
What this could lead to
If the software update works as intended, the monitor could deliver clearer 12-lead ECG readings, which may help clinicians assess heart rhythms more reliably.
What could go wrong
This is a small validation study of a device software update, not a treatment trial. The software may fail to produce diagnostic-quality tracings in some participants, and the study does not test whether better tracings improve patient outcomes.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Oct 2022

Finished

Nov 2022

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.

Ages

29 days to 89 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Able to read, write, speak, and understand English * Age: 29 days to 89 years * Willing and able to provide informed consent and complete study procedures * Willing to have Philips representatives present during study procedures. Exclusion Criteria: * Known allergy to medical adhesives, silicone, or latex (per self-report) * Any limitation or medical condition, including but not limited to physical or cognitive disability, that would affect the participant's ability to complete study activities (per investigator) * At the time of enrollment, current enrollment in any other interventional research study * An employee, or residing family member of an employee, of a company that designs, sells, or manufactures monitor/defibrillator technology or related products (including Philips)

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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

Contacts and locations

Locations

  • Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates)

    Lehigh Acres, Florida, 33971, United States

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