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AI stethoscope screens thousands of kids for heart disease

NCT ID NCT07194785

Diagnosis Sponsor: Heart Health Research Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether an AI-powered smart stethoscope can accurately detect structural heart disease in over 6,600 students aged 10-18 in China. Trained staff used the device to listen to heart sounds, and the AI flagged potential issues. Students with positive results, plus a random sample of those with negative results, received a standard echocardiogram to confirm. The goal was to see if this quick, non-invasive screening could reliably identify children who need further heart evaluation.

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 cardiac auscultation using the HearTech Smart Stethoscope
What this could lead to
If successful, this could provide a quick, low-cost way to screen large numbers of children for hidden heart problems, catching issues early.
What could go wrong
This is a completed diagnostic study, not a treatment trial. The AI stethoscope may miss some cases or give false alarms, and results may not apply to other populations or settings.

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

6,614 people

The number who actually took part.

Started

Oct 2025

Finished

Jan 2026

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.

Who is studied

Participants will be recruited from primary and secondary schools in Ruyang County, Henan Province, China. Screening will be conducted on-site at schools by trained personnel using AI-enabled smart stethoscopes. Students identified as having abnormal findings will be referred to the Cardiology Department of Ruyang County People's Hospital for confirmatory transthoracic echocardiography. A subset of students with normal screening results will also undergo echocardiography to estimate false-negative rates.

Ages

10 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: 1. School students aged 10-18 years. 2. Able to cooperate with cardiac auscultation. 3. Student and parent/guardian provide written informed consent. Exclusion Criteria: 1. Student or parent/guardian declines participation. 2. Inability or unwillingness to follow screening procedures or cooperate with cardiac auscultation. 3. Refusal to undergo standard transthoracic echocardiography or cardiology evaluation. 4. Previously diagnosed structural heart disease. 5. Chest wall deformities or skin conditions that may interfere with auscultation. 6. Fever ≥37.5 °C on the day of examination, or severe developmental delay or other conditions preventing cooperation with the examination.

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Conditions

The condition(s) this trial relates to.

heart disorder

As listed by the trial registrant

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

Structural heart disease

Contacts and locations

Locations

  • Ruyang County People's Hospital

    Luoyang, Henan, China

More trials for these conditions

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