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Can a smart device spot a hidden heart problem?

NCT ID NCT06351761

Diagnosis Sponsor: Withings 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a Withings device (BeamO with ECG app) can accurately detect atrial fibrillation, a common heart rhythm problem. Over 370 adults each had a 30-second ECG with the device and a standard 12-lead ECG for comparison. The goal was to see how well the device identifies AFib versus normal rhythm.

What this could mean

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

Active substance
Withings SCT02 device with ECG app
What this could lead to
If successful, this could provide a convenient way for people to check for atrial fibrillation at home using a simple device.
What could go wrong
This is a completed validation study, not a treatment trial. The device may not be as accurate as a standard ECG, and results may not apply to everyone.

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

373 people

The number who actually took part.

Started

Jun 2024

Finished

Nov 2025

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

22 years and older

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: * Male or female who are 22 years of age or older * Subject able to read, understand, and provide written informed consent * Subject willing and able to participate in the study procedures as described in the consent form * Subject able to communicate effectively with and willing to follow instructions from the study staff Exclusion Criteria: * Subject with an implanted electrical device (i.e. pacemaker, ICD …), whether active or inactive * Pathologic disorders that may affect motricity resulting in significant hands tremor that prevents subject from being able to hold still (e.g. Parkinson disease) * Myocardial Infarction (MI) within 90 days prior to the enrollment * Pulmonary embolism or pulmonary infarction within 90 days prior to the enrollment * Stroke or Transient Ischemic Attack (TIA) within 90 days prior to the enrollment * Active or history of life-threatening rhythms as determined by investigators (e.g. ventricular tachycardia, ventricular fibrillation, 3rd degree heart block) * Any cardiovascular disease that investigators would consider as a risk to subject or renders data uninterpretable (e.g. recent or ongoing unstable angina, decompensated heart failure, active myocarditis or pericarditis) * Active or symptomatic skin disease on Schiller electrode attachment sites or fingertips which would be in contact with BeamO electrodes (e.g. eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis) * Known sensitivity to medical adhesives, isopropyl alcohol,, electrocardiogram (ECG) electrodes, including known allergy or sensitivity to stainless steel (used in BeamO electrodes).

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation

Contacts and locations

Locations

  • Centre Cardiopole Trubert

    Paris, France

  • Diverse Clinical Research

    Miami, Florida, 33175, United States

  • FWD Clinical Research

    Boca Raton, Florida, 33486, United States

  • Henri Mondor University Hospital

    Créteil, Val de Marne, 94000, France

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