Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:21 PM
Study NCT ID:
NCT07375602
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-29
First Post:
2026-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multimodal AI Prediction Model for Complications After Transcatheter Closure of Perimembranous VSD in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D006345', 'term': 'Heart Septal Defects, Ventricular'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006343', 'term': 'Heart Septal Defects'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5249}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-21', 'studyFirstSubmitDate': '2026-01-21', 'studyFirstSubmitQcDate': '2026-01-21', 'lastUpdatePostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Procedure-Related Complications After Transcatheter Closure of Perimembranous VSD', 'timeFrame': 'Up to 30 Days After Transcatheter Closure', 'description': 'Occurrence of a composite endpoint of procedure-related complications, including arrhythmia requiring treatment, new-onset or worsened valvular regurgitation, residual shunt requiring reintervention, and device embolization.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Precision-Recall Curve (AUCPR) for Complication Prediction', 'timeFrame': 'Up to 30 Days After Transcatheter Closure', 'description': 'The area under the precision-recall curve (AUCPR) of the model for predicting the primary composite procedure-related complication endpoint.'}, {'measure': 'Sensitivity of the Model at a Pre-Specified Risk Threshold', 'timeFrame': 'Up to 30 Days After Transcatheter Closure', 'description': 'Sensitivity for predicting the primary composite procedure-related complication endpoint at a pre-specified probability (risk) threshold.'}, {'measure': 'Positive Predictive Value (PPV) of the Model at a Pre-Specified Risk Threshold', 'timeFrame': 'Up to 30 Days After Transcatheter Closure', 'description': 'Positive predictive value (PPV) for predicting the primary composite procedure-related complication endpoint at the same pre-specified probability (risk) threshold.'}, {'measure': 'Negative Predictive Value (NPV) of the Model at a Pre-Specified Risk Threshold', 'timeFrame': 'Up to 30 Days After Transcatheter Closure', 'description': 'Negative predictive value (NPV) for predicting the primary composite procedure-related complication endpoint at the same pre-specified probability (risk) threshold.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congenital Heart Disease (CHD)', 'Ventricular Septal Defects (VSD)', 'Cardiac Catheterization', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to develop and validate a multimodal artificial intelligence prediction model for treatment-related complications in children with perimembranous ventricular septal defect (pmVSD) undergoing transcatheter device closure. The main question it aims to answer is: Can an AI model that integrates demographics, laboratory results, electronic health record text, echocardiography reports, chest radiographs, and electrocardiogram accurately predict the risk of complications at the individual patient level? Data will be retrospectively collected from routine clinical care records of pediatric patients who underwent transcatheter closure for pmVSD. Deep learning methods will be used to extract features from text and images to train and validate the prediction model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children (18 years or younger) with echocardiography-confirmed perimembranous ventricular septal defect who underwent transcatheter device closure at Xinhua Hospital between January 1, 2015, and December 31, 2025, identified retrospectively from routine clinical care records.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≤ 18 years at the time of transcatheter procedure.\n* Diagnosis of perimembranous ventricular septal defect confirmed by echocardiography, and underwent transcatheter device closure at the study center.\n* Medical records sufficient to ascertain the primary outcome within the pre-specified follow-up window, and availability of minimum baseline clinical information required for model development/validation.\n\nExclusion Criteria:\n\n* Ventricular septal defects not classified as perimembranous on echocardiography, including muscular, outlet, or inlet VSDs, as well as multiple or complex VSDs involving more than one septal region.\n* Presence of complex congenital heart disease or associated structural abnormalities requiring concomitant surgical repair (e.g., tetralogy of Fallot).\n* Prior surgical VSD repair or prior transcatheter VSD closure.'}, 'identificationModule': {'nctId': 'NCT07375602', 'briefTitle': 'A Multimodal AI Prediction Model for Complications After Transcatheter Closure of Perimembranous VSD in Children', 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Multimodal Clinical Data Integration and Artificial Intelligence Modeling for Predicting Complications Following Pediatric Transcatheter Closure of Perimembranous Ventricular Septal Defect', 'orgStudyIdInfo': {'id': 'XHEC-C-2025-295-1'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kun Sun', 'role': 'CONTACT', 'email': 'drsunkun@xinhuamed.com.cn', 'phone': '021-13601846338'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'De-identified individual participant data will not be made publicly available due to privacy considerations and institutional data governance policies for retrospective electronic health record and imaging data. Aggregated results may be shared in publications and presentations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Department of Pediatric Cardiology', 'investigatorFullName': 'Kun Sun', 'investigatorAffiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}}}}