Congenital Heart Disease (CHD)NCT07662343
Early Warning of Structural Complications in Perimembranous VSD
An observational study of Congenital Heart Disease (CHD) and Ventricular Septal Defects (VSD), run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The goal of this observational study is to develop and test a AI-based prediction model for children with perimembranous ventricular septal defect, also called PMVSD. PMVSD is a type of hole between the lower chambers of the heart. Read more about this study
- Who is it for?
- Ages 0 to 14 years
- Conditions the study is for
- Congenital Heart Disease (CHD), Ventricular Septal Defects (VSD)
- How many people
- 11,683 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2004to 1 Jul 2027
- Phase
- Observational
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients with perimembranous ventricular septal defect evaluated at six tertiary referral centers between 2004 and 2022.
Who may be able to join
- Children aged 14 years or younger at the time of presentation/diagnosis;
- Confirmed diagnosis of perimembranous ventricular septal defect (PMVSD), or PMVSD accompanied by minor cardiac anomalies that do not alter the hemodynamic status of the VSD, including small patent foramen ovale, atrial septal defect, patent ductus arteriosus, or persistent left superior vena cava;
- Availability of at least two consecutive follow-up records, with consistency between the electronic echocardiography reports and the Hospital Information System data.
Who cannot join
- Age older than 14 years at diagnosis;
- Presence of complex congenital heart disease;
- Patients lost to follow-up due to inability to establish contact, resulting in an indeterminate clinical outcome.
Trial locations and contacts
1 site in 1 country.
China1 site
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
About this study
Official title: Early Warning of Structural Complications Related to Perimembranous Ventricular Septal Defect Using Unstructured Echocardiographic Text Mining and Machine Learning
The goal of this observational study is to develop and test a AI-based prediction model for children with perimembranous ventricular septal defect, also called PMVSD. PMVSD is a type of hole between the lower chambers of the heart. Some children with PMVSD may later develop heart structure problems, such as aortic valve prolapse or leakage, subaortic fibrous ridge, left ventricle-to-right atrium shunt, or right ventricular outflow tract obstruction.
This study will use past medical records and echocardiography reports from children who received care at six hospitals in China between 2004 and 2022. The main questions it aims to answer are:
Read more
Can information written in echocardiography reports help predict which children with PMVSD are more likely to develop heart structure problems? Can natural language processing and machine learning improve early risk prediction when used together with routine clinical information? Researchers will review existing, de-identified medical data. They will use natural language processing to turn written descriptions in echocardiography reports into data that a computer model can analyze. These descriptions may include details about the edge of the heart defect, the direction of blood flow, and the relationship between the defect and nearby heart valves.
Participants will not receive any study treatment or extra tests. The study will only use information already collected during routine medical care. The prediction models will be trained and tested using data from different hospitals to see how well they work across medical centers.
- Medical subject headings
- Heart Defects, Congenital, Heart Septal Defects, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Training cohort | Participants from the multicenter retrospective dataset used for model development. Unstructured echocardiographic text and clinical data from this cohort will be used for feature extraction, model training, and internal optimization to establish an early warning model for structural complications related to perimembranous ventricular septal defect. | |
| Validaction cohort | An independent subset of participants from the multicenter retrospective dataset used for model validation. Data from this cohort will be used to evaluate the discrimination, calibration, and generalizability of the developed early warning model for structural complications related to perimembranous ventricular septal defect. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Perimembranous Ventricular Septal Defect Related Structural Complications
Occurrence of at least one structural complication related to perimembranous ventricular septal defect, as identified by echocardiography, including: (1) aortic valve prolapse and/or aortic regurgitation, defined as valvular leaflet displacement into the defect and/or regurgitation detected by color Doppler; (2) subaortic fibrous ridge, defined as abnormal fibrous strand or ridge-like echogenicity in the left ventricular outflow tract; (3) left ventricle-to-right atrium shunt; or (4) right ventricular outflow tract obstruction, defined as abnormal muscular bundle hypertrophy with increased Doppler flow velocity and a peak pressure gradient greater than 20 mmHg.
Measured: From initial diagnosis through 3 years after diagnosis
Secondary outcomes (4)
Area Under the Precision-Recall Curve (AUCPR) for Complication Prediction
The area under the precision-recall curve (AUCPR) of the model for predicting PMVSD-related complication endpoint.
Measured: From initial diagnosis through 3 years after diagnosis
Sensitivity of the Model at a Pre-Specified Risk Threshold
Sensitivity for predicting PMVSD-related complication endpoint at a pre-specified probability (risk) threshold.
Measured: From initial diagnosis through 3 years after diagnosis
Positive Predictive Value (PPV) of the Model at a Pre-Specified Risk Threshold
Positive predictive value (PPV) for predicting PMVSD-related complication endpoint at the same pre-specified probability (risk) threshold.
Measured: From initial diagnosis through 3 years after diagnosis
Negative Predictive Value (NPV) of the Model at a Pre-Specified Risk Threshold
Negative predictive value (NPV) for predicting PMVSD-related complication endpoint at the same pre-specified probability (risk) threshold.
Measured: From initial diagnosis through 3 years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Jan 2004
- Primary completion1 Jan 2022
- Study completion1 Jul 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.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11,683 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun Sun, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662343
- Sponsor's protocol ID
- XHEC-C-2026-099
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Warning of Structural Complications Related to Perimembranous Ventricular Septal Defect Using Unstructured Echocardiographic Text Mining and Machine Learning
- ClinicalTrials.gov ID
- NCT07662343
- Acronym / sponsor ID
- XHEC-C-2026-099
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 11,683 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2004 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 23 Jun 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.
The goal of this observational study is to develop and test a AI-based prediction model for children with perimembranous ventricular septal defect, also called PMVSD. PMVSD is a type of hole between the lower chambers of the heart. Some children with PMVSD may later develop heart structure problems, such as aortic valve prolapse or leakage, subaortic fibrous ridge, left ventricle-to-right atrium shunt, or right ventricular outflow tract obstruction.
This study will use past medical records and echocardiography reports from children who received care at six hospitals in China between 2004 and 2022. The main questions it aims to answer are:
Can information written in echocardiography reports help predict which children with PMVSD are more likely to develop heart structure problems? Can natural language processing and machine learning improve early risk prediction when used together with routine clinical information? Researchers will review existing, de-identified medical data. They will use natural language processing to turn written descriptions in echocardiography reports into data that a computer model can analyze. These descriptions may include details about the edge of the heart defect, the direction of blood flow, and the relationship between the defect and nearby heart valves.
Participants will not receive any study treatment or extra tests. The study will only use information already collected during routine medical care. The prediction models will be trained and tested using data from different hospitals to see how well they work across medical centers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training cohort | – | –Participants from the multicenter retrospective dataset used for model development. Unstructured echocardiographic text and clinical data from this cohort will be used for feature extraction, model training, and internal optimization to establish an early warning model for structural complications related to perimembranous ventricular septal defect. |
| Validaction cohort | – | –An independent subset of participants from the multicenter retrospective dataset used for model validation. Data from this cohort will be used to evaluate the discrimination, calibration, and generalizability of the developed early warning model for structural complications related to perimembranous ventricular septal defect. |
Who may qualify
- Ages
- 0 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients with perimembranous ventricular septal defect evaluated at six tertiary referral centers between 2004 and 2022.
Key inclusion criteria (3 listed)
- Children aged 14 years or younger at the time of presentation/diagnosis;
- Confirmed diagnosis of perimembranous ventricular septal defect (PMVSD), or PMVSD accompanied by minor cardiac anomalies that do not alter the hemodynamic status of the VSD, including small patent foramen ovale, atrial septal defect, patent ductus arteriosus, or persistent left superior vena cava;
- Availability of at least two consecutive follow-up records, with consistency between the electronic echocardiography reports and the Hospital Information System data.
Key exclusion criteria (3 listed)
- Age older than 14 years at diagnosis;
- Presence of complex congenital heart disease;
- Patients lost to follow-up due to inability to establish contact, resulting in an indeterminate clinical outcome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of Perimembranous Ventricular Septal Defect Related Structural Complications
Time frame: From initial diagnosis through 3 years after diagnosis
Occurrence of at least one structural complication related to perimembranous ventricular septal defect, as identified by echocardiography, including: (1) aortic valve prolapse and/or aortic regurgitation, defined as valvular leaflet displacement into the defect and/or regurgitation detected by color Doppler; (2) subaortic fibrous ridge, defined as abnormal fibrous strand or ridge-like echogenicity in the left ventricular outflow tract; (3) left ventricle-to-right atrium shunt; or (4) right ventricular outflow tract obstruction, defined as abnormal muscular bundle hypertrophy with increased Doppler flow velocity and a peak pressure gradient greater than 20 mmHg.
4 secondary outcomes
Area Under the Precision-Recall Curve (AUCPR) for Complication Prediction
Time frame: From initial diagnosis through 3 years after diagnosis
Sensitivity of the Model at a Pre-Specified Risk Threshold
Time frame: From initial diagnosis through 3 years after diagnosis
Positive Predictive Value (PPV) of the Model at a Pre-Specified Risk Threshold
Time frame: From initial diagnosis through 3 years after diagnosis
Negative Predictive Value (NPV) of the Model at a Pre-Specified Risk Threshold
Time frame: From initial diagnosis through 3 years after diagnosis
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 23 Jun 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. 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?
An observational study of Congenital Heart Disease (CHD) and Ventricular Septal Defects (VSD), run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 23 Jun 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?
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?
Occurrence of Perimembranous Ventricular Septal Defect Related Structural Complications (time frame: From initial diagnosis through 3 years after diagnosis). 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 23 Jun 2026.