Congenital Heart Disease (CHD)NCT07830251
AI-Assisted Versus Independent Heart Sound Screening for Congenital Heart Disease in Children
A study testing AI-Assisted Cardiac Auscultation in people with Congenital Heart Disease (CHD) and Artifical Intelligence, run by Kun Sun at 1 site in China.
Trial summary
This is a prospective, school-based, cluster-randomized controlled trial conducted in Qinghai Province, China. The study will evaluate whether artificial intelligence (AI) can help primary care physicians identify congenital heart disease (CHD) during large-scale screening of children and adolescents. Read more about this study
- Who is it for?
- Ages 0 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease (CHD), Artifical Intelligence, Screening
- What is being tested?
- AI-Assisted Cardiac Auscultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children and adolescents aged 0-18 years who are enrolled in a participating school in Qinghai Province and are eligible for the school-based congenital heart disease screening program.
- Written informed consent provided by the parent or legal guardian, or ethics-approved electronic informed consent, with participant assent obtained when applicable.
- Ability to undergo the protocol-specified cardiac auscultation, heart-sound recording, and echocardiographic assessment.
- Participant and/or parent or legal guardian is willing to provide the required medical history and, if referral is recommended, follow-up information.
Who cannot join
- Inability to cooperate with cardiac auscultation, heart-sound recording, or echocardiography, when the required procedure cannot be completed after reasonable attempts.
- Known congenital heart disease previously treated with catheter-based intervention or cardiac surgery, when the primary endpoint is not applicable under the protocol.
- Any condition that prevents completion of the required study procedures or prevents obtaining an interpretable protocol-specified echocardiographic assessment.
- Informed consent or assent is not provided, or consent is withdrawn before completion of the study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, School-Based, Cluster-Randomized Controlled Trial Comparing AI-Assisted Versus Independent Cardiac Auscultation by Primary Care Physicians for Detecting Congenital Heart Disease in Qinghai Province, China
This is a prospective, school-based, cluster-randomized controlled trial conducted in Qinghai Province, China. The study will evaluate whether artificial intelligence (AI) can help primary care physicians identify congenital heart disease (CHD) during large-scale screening of children and adolescents.
Eligible schools, rather than individual participants, will be randomly assigned to one of two screening approaches: independent cardiac auscultation by primary care physicians or AI-assisted cardiac auscultation. In both groups, primary care physicians will perform cardiac auscultation and record heart sounds. In the AI-assisted group, the physicians will also receive AI analysis of the recorded heart sounds to support their final screening decision.
Participants will undergo medical history collection, cardiac auscultation, heart-sound recording, and echocardiography. Echocardiography and expert review will serve as the reference standard. The primary outcome is the sensitivity of each screening approach for detecting CHD that may require clinical intervention or specialist management. The study will also assess detection of all CHD, referral completion, confirmed diagnoses after referral, and related screening outcomes.
- Conditions
- Congenital Heart Disease (CHD), Artifical Intelligence, Screening, Cardiac Auscultation, Primary Care Physician
- Being tested
- AI-Assisted Cardiac Auscultation
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Assisted Cardiac AuscultationOther
During the school-based screening visit, a trained primary care physician will perform standardized cardiac auscultation and record the participant's heart sounds. The recorded heart sounds will be analyzed by an artificial intelligence-assisted auscultation system, which will provide automated analysis and decision-support feedback to the physician. The physician will consider the AI output together with the clinical examination and make the final screening and referral decision. The AI output is not a definitive diagnosis and will not replace echocardiography or specialist evaluation. No medication, surgery, or other therapeutic treatment will be administered as part of this intervention.
| Study group | Role | What they receive |
|---|---|---|
| Primary care physicians | No intervention | Not described |
| AI + Primary care physicians | Experimental | Not described Receives: Other: AI-Assisted Cardiac Auscultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity for Detecting Congenital Heart Disease Requiring Clinical Intervention
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (5)
Specificity for Detecting Congenital Heart Disease Requiring Clinical Intervention
Measured: From enrollment to the end of treatment at 6 months
Sensitivity for Detecting All Congenital Heart Disease
Measured: From enrollment to the end of treatment at 6 months
Positive Predictive Value for Detecting Congenital Heart Disease Requiring Clinical Intervention
Measured: From enrollment to the end of treatment at 6 months
Referral Completion Rate
Measured: From the initial screening visit through completion of the protocol-specified referral follow-up at 9 months
Confirmed Diagnosis Rate After Referral
Measured: From the initial screening visit through completion of the protocol-specified referral follow-up at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start14 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kun Sun
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Women and Children Hospital of Qinghai Province
- Responsible party
- Sponsor-investigator, Kun Sun, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Kun Sun, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of MedicineXiulian Jiang, Principal investigator, Women and Children Hospital of Qinghai Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830251
- Sponsor's protocol ID
- 2026QHFELL K14/W
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, School-Based, Cluster-Randomized Controlled Trial Comparing AI-Assisted Versus Independent Cardiac Auscultation by Primary Care Physicians for Detecting Congenital Heart Disease in Qinghai Province, China
- ClinicalTrials.gov ID
- NCT07830251
- Acronym / sponsor ID
- 2026QHFELL K14/W
- Conditions
- Congenital Heart Disease (CHD), Artifical Intelligence, Screening, Cardiac Auscultation, Primary Care Physician
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Kun SunUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Women and Children Hospital of Qinghai Province
- Study start
- 14 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, school-based, cluster-randomized controlled trial conducted in Qinghai Province, China. The study will evaluate whether artificial intelligence (AI) can help primary care physicians identify congenital heart disease (CHD) during large-scale screening of children and adolescents.
Eligible schools, rather than individual participants, will be randomly assigned to one of two screening approaches: independent cardiac auscultation by primary care physicians or AI-assisted cardiac auscultation. In both groups, primary care physicians will perform cardiac auscultation and record heart sounds. In the AI-assisted group, the physicians will also receive AI analysis of the recorded heart sounds to support their final screening decision.
Participants will undergo medical history collection, cardiac auscultation, heart-sound recording, and echocardiography. Echocardiography and expert review will serve as the reference standard. The primary outcome is the sensitivity of each screening approach for detecting CHD that may require clinical intervention or specialist management. The study will also assess detection of all CHD, referral completion, confirmed diagnoses after referral, and related screening outcomes.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary care physicians | No intervention | – |
| AI + Primary care physicians | Experimental | Other: AI-Assisted Cardiac Auscultation |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children and adolescents aged 0-18 years who are enrolled in a participating school in Qinghai Province and are eligible for the school-based congenital heart disease screening program.
- Written informed consent provided by the parent or legal guardian, or ethics-approved electronic informed consent, with participant assent obtained when applicable.
- Ability to undergo the protocol-specified cardiac auscultation, heart-sound recording, and echocardiographic assessment.
- Participant and/or parent or legal guardian is willing to provide the required medical history and, if referral is recommended, follow-up information.
Key exclusion criteria (4 listed)
- Inability to cooperate with cardiac auscultation, heart-sound recording, or echocardiography, when the required procedure cannot be completed after reasonable attempts.
- Known congenital heart disease previously treated with catheter-based intervention or cardiac surgery, when the primary endpoint is not applicable under the protocol.
- Any condition that prevents completion of the required study procedures or prevents obtaining an interpretable protocol-specified echocardiographic assessment.
- Informed consent or assent is not provided, or consent is withdrawn before completion of the study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Assisted Cardiac AuscultationDuring the school-based screening visit, a trained primary care physician will perform standardized cardiac auscultation and record the participant's heart sounds. The recorded heart sounds will be analyzed by an artificial intelligence-assisted auscultation system, which will provide automated analysis and decision-support feedback to the physician. The physician will consider the AI output together with the clinical examination and make the final screening and referral decision. The AI output is not a definitive diagnosis and will not replace echocardiography or specialist evaluation. No medication, surgery, or other therapeutic treatment will be administered as part of this intervention. | Other | AI + Primary care physicians |
Primary outcome
Sensitivity for Detecting Congenital Heart Disease Requiring Clinical Intervention
Time frame: From enrollment to the end of treatment at 6 months
5 secondary outcomes
Specificity for Detecting Congenital Heart Disease Requiring Clinical Intervention
Time frame: From enrollment to the end of treatment at 6 months
Sensitivity for Detecting All Congenital Heart Disease
Time frame: From enrollment to the end of treatment at 6 months
Positive Predictive Value for Detecting Congenital Heart Disease Requiring Clinical Intervention
Time frame: From enrollment to the end of treatment at 6 months
Referral Completion Rate
Time frame: From the initial screening visit through completion of the protocol-specified referral follow-up at 9 months
Confirmed Diagnosis Rate After Referral
Time frame: From the initial screening visit through completion of the protocol-specified referral follow-up at 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kun Sun principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Xiulian Jiang principal investigator
Women and Children Hospital of Qinghai Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Assisted Cardiac Auscultation in people with Congenital Heart Disease (CHD) and Artifical Intelligence, run by Kun Sun at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liudan Zhao (0086-18368407858, sjdyszld@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity for Detecting Congenital Heart Disease Requiring Clinical Intervention (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.