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AI stethoscope boosts heart defect detection in kids

NCT ID NCT06791096

Diagnosis Sponsor: Kun Sun 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed trial compared how well primary care doctors detect congenital heart disease in children using either their own listening skills or an AI-assisted stethoscope. The AI analyzes heart sounds in real time and gives an immediate result. The study enrolled 212 children and measured sensitivity, specificity, and accuracy of both methods.

What this could mean

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

Active substance
AI-assisted electronic stethoscope
What this could lead to
If successful, this could give primary care doctors a simple, accurate tool to screen for congenital heart disease in children, potentially catching cases earlier.
What could go wrong
The trial is completed but relatively small (212 participants) and was done in specialized hospitals, so results may not apply everywhere. AI may still miss some cases or give false alarms.

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

212 people

The number who actually took part.

Started

Feb 2025

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

Up to 18 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: * Age between 0 to 18 years, with no gender restrictions. * Children who consent to undergo echocardiography to determine the presence or absence of congenital heart disease. * Voluntary participation in this study and signing of an informed consent form. Exclusion Criteria: * Age greater than 18 years. * Children who are unable to undergo echocardiography or who do not cooperate with auscultation. * Participants who cannot provide informed consent or are unwilling to comply with study requirements to provide medical data for further analysis and research.

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Conditions

The condition(s) this trial relates to.

congenital heart disease

As listed by the trial registrant

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

Artifical intelligence Auscultation for clinical evaluation Congenital heart disease (CHD) Randomised controlled trial Screening tool

Contacts and locations

Locations

  • Qinghai Provincial Women and Children's Hospital

    Qinghai, China

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.