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Can AI hear heart defects in children? a large trial puts it to the test

NCT ID NCT04307030

Diagnosis Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This study is testing whether an artificial intelligence system can accurately identify congenital heart disease in children by analyzing heart sounds. It will involve thousands of children, with and without heart conditions, to compare the AI's performance against traditional methods like auscultation by a doctor and echocardiography. The goal is to see if this AI-assisted approach could be a reliable, easy-to-use screening tool for early detection.

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 heart sound recognition system
What this could lead to
If successful, this could provide a quick, non-invasive, and widely accessible screening tool to detect congenital heart disease in children earlier, potentially improving outcomes.
What could go wrong
The AI's accuracy may not be high enough to replace standard methods, and it might miss some heart defects or produce false alarms. Its performance in real-world settings may vary.

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

9,370 people

The number who actually took part.

Started

Jul 2020

Finished

May 2024

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

Pediatric population during outpatient service or hospitalization in ten pediatric medical centers in CHINA

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: 1. 0 \~ 18 years of age, regardless of gender ； 2. Children with or without congenital heart disease confirmed by echocardiography； 3. On the basis of informed consent，willing to cooperate with our group. Exclusion Criteria: 1. ≥ 18 years of age; 2. Children who can not undergo echocardiography or other related tests; 3. Subjects who refuse to join in, or who are unwilling to cooperate with the provision of diagnostic and therapeutic 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.

Congenital heart disease in children

Contacts and locations

Locations

  • Beijing Anzhen Hospital

    Beijing, China

  • Children's Hospital Affiliated to Chongqing Medical University

    Chongqing, China

  • Children's Hospital Affiliated to Zhejiang Medical University

    Hangzhou, China

  • Children's Hospital of Shanghai

    Shanghai, China

  • Children's Hospital of Soochow University

    Suzhou, China

  • Guangzhou Women and Children's Medical Center

    Guangzhou, China

  • Hunan Children's Hospital

    Hunan, China

  • Kunming Children's Hospital

    Kunming, China

  • Lanzhou University Second Hospital

    Lanzhou, China

  • Linyi Hospital for Women and Children

    Linyi, China

  • Shandong Provincial Hospital

    Jinan, China

  • Shanghai Children's Medical Center

    Shanghai, China

  • Shiyan Taihe Hospital

    Shiyan, China

  • The First Affiliated Hospital of Guangxi Medical University

    Guangxi, China

  • The Second Hospital Affiliated to Wenzhou Medical University

    Wenzhou, China

  • Wuhan Children's Hospital

    Wuhan, China

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