An interventional study of AI-Assisted Cardiac Auscultation in Congenital Heart Disease (CHD), Artifical Intelligence and Screening, sponsored by Kun Sun. Not yet recruiting at 1 site in China. Open to participants aged 0 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Kun Sun · Not applicable, Interventional, and Screening
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Among 79 studies in Heart Defects, Congenital with a site in China — 27 open to participants now, 30 under way, none of them phase 3. Heart Defects, Congenital · China.
Among the 79 studies in Heart Defects, Congenital with a site in China, this one is the 2nd largest by planned enrollment of the 41 interventional ones that give a count, is one of 8 that started in 2026, is one of 31 with no phase, reaches primary completion later than 20 of the 29 other live ones, and was the 78th registered.
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
Browse Heart Defects, Congenital studies →27 of the 79 studies in Heart Defects, Congenital with a site in China are open now. Recruiting first, the newest first:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Sites in China
Ages up to 18
Children's Hospital of Fudan University · Sites in China
Ages 0 mo–6 mo
Yan Fuxia · Sites in China
Ages 1 days–3 yrs
Yan Fuxia · Sites in China
Ages 6–12
China National Center for Cardiovascular Diseases · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 154 Heart Defects, Congenital studies recruiting now, 67 (44%) set no upper age limit and 79 (51%) stop at 75 or younger; 110 take children under 18; 25 take healthy volunteers.
This study: 0 Years to 18 Years · all sexes · healthy volunteers too.
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79 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 3 · Phase 3 5 · Phase 4 2
First in 2000; this study’s year is marked. 8 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 10,000 is above the median of 60 across 507 interventional studies indexed under Heart Defects, Congenital.
Median enrollment 160 across the 41 interventional studies, 1,554 across the 38 observational. Of the 30 that completed or were terminated, 3 (10%) have results posted.
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3 of 79 have an industry lead sponsor. The 10 most frequent:
Kun Sun is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Kun Sun has 3 studies filed under Heart Defects, Congenital — fewer than ten, so there is no comparison to draw.
6 of the studies in Heart Defects, Congenital with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06747546Children's Hospital of Fudan UniversityResearch on Circulation Management Strategy Based on Oxygen Metabolism Balance After CHD Surgery | 2026-12-31 |
| NCT06542120Xinhua Hospital, Shanghai Jiao Tong University School of MedicineResearch on Body Voice AI Recognition System for Children's Health Management | 2026-12-31 |
| NCT07115108Children's Hospital of Fudan UniversityEffectiveness of High-Energy Density Enteral Nutrition for Enhancing Physical Growth and Cognitive Brain Development in Infants With Congenital Heart Disease | 2026-12-31 |
| NCT07854145Shanghai Jiao Tong University School of MedicineStarry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery | 2027-03-31 |
| NCT07375602Xinhua Hospital, Shanghai Jiao Tong University School of MedicineA Multimodal AI Prediction Model for Complications After Transcatheter Closure of Perimembranous VSD in Children | 2027-06-01 |
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Among the 79 studies in Heart Defects, Congenital with a site in China, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: AI-Assisted Cardiac Auscultation
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.
Sensitivity for Detecting Congenital Heart Disease Requiring Clinical Intervention
Time frame: From enrollment to the end of treatment at 6 months
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2027, 15 months later.
Of 205 non-industry interventional studies with no phase under Heart Defects, Congenital, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 15 months is below that.
Counting every sponsor, half of 223 studies reached it within 34 months; a quarter within 17 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Kun Sun