Congenital Heart Disease (CHD)NCT06791109
"SOUND" Trial: Study of On-site Use of Novel AI-assisted Diagnostics in CHD Screening
A study testing Primary care physicians and AI + Primary care physicians in people with Congenital Heart Disease (CHD) and Screening Tool, run by Kun Sun at 1 site in China.
Trial summary
This study plans to conduct clinical validation of the model in real clinical settings, comparing it with primary care physicians and specialist physicians to ensure the model's practicality. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease (CHD), Screening Tool, Artificial Intelligence (AI)
- What is being tested?
- Primary care physicians and AI + Primary care physicians
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19,697 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2025to 4 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The school is of the type: kindergarten, primary school, junior high school, or senior high school.
- The school has medical screening facilities and conditions that can support AI-assisted screening.
- The area where the school is located has at least one primary healthcare institution willing to participate in this trial.
- The school's management and teaching staff are willing to participate in the study and can cooperate to complete the related screening and data collection work.
- Children aged between 0 and 18 years, regardless of gender.
- Children who agree to undergo echocardiography to determine the presence of congenital heart disease.
- Individuals who voluntarily participate in this study and sign the informed consent form.
Who cannot join
- More than half of the students in the school refuse to participate in the trial.
- Schools that are unable to complete the study due to severe limitations in geographical location and transportation conditions.
- Schools lacking medical screening facilities and conditions necessary for the implementation of screening.
- Areas where there are no primary healthcare institutions willing to participate in this trial.
- Schools whose management and teaching staff refuse to participate in the study or are unable to cooperate in completing the related screening and data collection work.
- Individuals over the age of 18.
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- Children who are unable to complete echocardiography or do not cooperate with auscultation.
- Participants who are unable to provide informed consent or are unwilling to comply with the study requirements to provide medical data for further analysis and research.
- Participants who have received interventional or surgical treatment for CHD.
Trial locations and contacts
1 site in 1 country.
China1 site
Qinghai Provincial Women and Children's Hospital
Xining, Qinghai, 810007
About this study
Official title: Efficacy Comparison Between Independent Auscultation by Primary Care Physicians and AI-Assisted Auscultation in Large-scale Screening for Congenital Heart Disease: A Cluster Randomized Controlled Trial in China
This study plans to conduct clinical validation of the model in real clinical settings, comparing it with primary care physicians and specialist physicians to ensure the model's practicality. Through continuous optimization and practice, the study aims to use AI-assisted heart sound auscultation to empower the auscultation capabilities of primary care obstetricians, pediatricians, and non-cardiovascular specialists nationwide. This will not only reduce the missed diagnosis rate and improve the detection rate of existing CHD screenings, but also expand the coverage of current CHD screening networks, incorporating newborns, infants, preschool children, children, and adolescents aged 0-18 years into the screening scope. The study aims to establish a new benchmark in child health management by providing feasible and cost-effective child health management solutions for other developing countries, contributing to global efforts for the health of children.
- Conditions
- Congenital Heart Disease (CHD), Screening Tool, Artificial Intelligence (AI), Cluster Randomized Trial, Auscultation for Clinical Evaluation
- Being tested
- Primary care physicians, AI + Primary care physicians
- 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.
Primary care physiciansDiagnostic test
For participants in Group A, a nonblinded independent staff member will first collect medical history, followed by sequential auscultation and CHD assessment by a specialist physician and a primary care physician, with an echocardiogram performed last.
AI + Primary care physiciansDiagnostic test
For participants in Group B, after medical history collection, both a specialist physician and a primary care physician will perform auscultation and CHD assessment. Subsequently, the primary care physician will use an electronic stethoscope to collect heart sound data according to the protocol and upload the recordings to a cloud platform. The AI model will analyze the data on the cloud platform and provide a diagnostic result within 5-10 seconds for the primary care physician's reference. The primary care physician may reassess the findings based on the AI model's feedback, and the participant will then undergo an echocardiogram.
| Study group | Role | What they receive |
|---|---|---|
| Primary care physicians | Active comparator | Not described Receives: Diagnostic Test: Primary care physicians |
| AI + Primary care physicians | Experimental | Not described Receives: Diagnostic Test: AI + Primary care physicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of auscultation in identifying CHD between independent auscultation by primary care physicians and AI-assisted auscultation by primary care physicians
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (4)
Sensitivity of Auscultation in CHD Detection: AI model & Experienced Cardiologists' Independent Auscultatio
Measured: From enrollment to the end of treatment at 6 months
Specificity of Auscultation in CHD Detection: Primary Care Physicians' Independent Auscultation & AI-assisted Primary Healthcare Physicians' Auscultation & AI model & Experienced Cardiologists' Independent Auscultation
Measured: From enrollment to the end of treatment at 6 months
Accuracy of Auscultation in CHD Detection: Primary Care Physicians' Independent Auscultation & AI-assisted Primary Care Physicians' Auscultation & AI model & Experienced Cardiologists' Independent Auscultation
Measured: From enrollment to the end of treatment at 6 months
The rate of diagnostic revisions by physicians, the proportions of correct and incorrect changes
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start22 Sep 2025
- Primary completion18 Nov 2025
- Study completion4 Jan 2026
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
- 19,697 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kun Sun
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor-investigator, Kun Sun, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791109
- Sponsor's protocol ID
- XHEC-C-2025-013-1
- Other IDs
- INV-072724
- Status last verified
- Feb 2026
- First submitted
- 18 Jan 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may not be shared or may be unavailable for sharing due to several reasons. Firstly, confidentiality is of utmost importance. IPD contains sensitive personal information, and sharing such data could potentially compromise the privacy of participants, thereby restricting the sharing of such detailed information. Secondly, the data is protected by intellectual property rights. This may limit its sharing without proper agreements or permissions. Thirdly, IPD is large in volume and complex in nature, requiring substantial resources for storage, transmission, and analysis. Detailed discussions and plans need to be formulated to ensure the integrity and security of the data during the sharing process.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Comparison Between Independent Auscultation by Primary Care Physicians and AI-Assisted Auscultation in Large-scale Screening for Congenital Heart Disease: A Cluster Randomized Controlled Trial in China
- ClinicalTrials.gov ID
- NCT06791109
- Acronym / sponsor ID
- XHEC-C-2025-013-1
- Conditions
- Congenital Heart Disease (CHD), Screening Tool, Artificial Intelligence (AI), Cluster Randomized Trial, Auscultation for Clinical Evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19,697 participants (actual)
- Lead sponsor
- Kun SunUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 4 Jan 2026 (actual)
- First posted
- 24 Jan 2025 (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 study plans to conduct clinical validation of the model in real clinical settings, comparing it with primary care physicians and specialist physicians to ensure the model's practicality. Through continuous optimization and practice, the study aims to use AI-assisted heart sound auscultation to empower the auscultation capabilities of primary care obstetricians, pediatricians, and non-cardiovascular specialists nationwide. This will not only reduce the missed diagnosis rate and improve the detection rate of existing CHD screenings, but also expand the coverage of current CHD screening networks, incorporating newborns, infants, preschool children, children, and adolescents aged 0-18 years into the screening scope. The study aims to establish a new benchmark in child health management by providing feasible and cost-effective child health management solutions for other developing countries, contributing to global efforts for the health of children.
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 | Active comparator | Diagnostic Test: Primary care physicians |
| AI + Primary care physicians | Experimental | Diagnostic Test: AI + Primary care physicians |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- The school is of the type: kindergarten, primary school, junior high school, or senior high school.
- The school has medical screening facilities and conditions that can support AI-assisted screening.
- The area where the school is located has at least one primary healthcare institution willing to participate in this trial.
- The school's management and teaching staff are willing to participate in the study and can cooperate to complete the related screening and data collection work.
- Children aged between 0 and 18 years, regardless of gender.
Key exclusion criteria (9 listed)
- More than half of the students in the school refuse to participate in the trial.
- Schools that are unable to complete the study due to severe limitations in geographical location and transportation conditions.
- Schools lacking medical screening facilities and conditions necessary for the implementation of screening.
- Areas where there are no primary healthcare institutions willing to participate in this trial.
- Schools whose management and teaching staff refuse to participate in the study or are unable to cooperate in completing the related screening and data collection work.
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 |
|---|---|---|
| Primary care physiciansFor participants in Group A, a nonblinded independent staff member will first collect medical history, followed by sequential auscultation and CHD assessment by a specialist physician and a primary care physician, with an echocardiogram performed last. | Diagnostic test | Primary care physicians |
| AI + Primary care physiciansFor participants in Group B, after medical history collection, both a specialist physician and a primary care physician will perform auscultation and CHD assessment. Subsequently, the primary care physician will use an electronic stethoscope to collect heart sound data according to the protocol and upload the recordings to a cloud platform. The AI model will analyze the data on the cloud platform and provide a diagnostic result within 5-10 seconds for the primary care physician's reference. The primary care physician may reassess the findings based on the AI model's feedback, and the participant will then undergo an echocardiogram. | Diagnostic test | AI + Primary care physicians |
Primary outcome
Sensitivity of auscultation in identifying CHD between independent auscultation by primary care physicians and AI-assisted auscultation by primary care physicians
Time frame: From enrollment to the end of treatment at 6 months
4 secondary outcomes
Sensitivity of Auscultation in CHD Detection: AI model & Experienced Cardiologists' Independent Auscultatio
Time frame: From enrollment to the end of treatment at 6 months
Specificity of Auscultation in CHD Detection: Primary Care Physicians' Independent Auscultation & AI-assisted Primary Healthcare Physicians' Auscultation & AI model & Experienced Cardiologists' Independent Auscultation
Time frame: From enrollment to the end of treatment at 6 months
Accuracy of Auscultation in CHD Detection: Primary Care Physicians' Independent Auscultation & AI-assisted Primary Care Physicians' Auscultation & AI model & Experienced Cardiologists' Independent Auscultation
Time frame: From enrollment to the end of treatment at 6 months
The rate of diagnostic revisions by physicians, the proportions of correct and incorrect changes
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Undecided. IPD may not be shared or may be unavailable for sharing due to several reasons. Firstly, confidentiality is of utmost importance. IPD contains sensitive personal information, and sharing such data could potentially compromise the privacy of participants, thereby restricting the sharing of such detailed information. Secondly, the data is protected by intellectual property rights. This may limit its sharing without proper agreements or permissions. Thirdly, IPD is large in volume and complex in nature, requiring substantial resources for storage, transmission, and analysis. Detailed discussions and plans need to be formulated to ensure the integrity and security of the data during the sharing process.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary care physicians and AI + Primary care physicians in people with Congenital Heart Disease (CHD) and Screening Tool, 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 7 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of auscultation in identifying CHD between independent auscultation by primary care physicians and AI-assisted auscultation by primary care physicians (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 7 Apr 2026.