Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-24 @ 5:42 PM
Study NCT ID:
NCT06751368
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2024-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Fate of Aortic Valve After SAS Surgery in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D001022', 'term': 'Aortic Valve Insufficiency'}], 'ancestors': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 232}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-24', 'studyFirstSubmitDate': '2024-12-19', 'studyFirstSubmitQcDate': '2024-12-24', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Postoperative significant AR (SAR)', 'timeFrame': 'Through study completion, an average of 4 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Subaortic Stenosis', 'Congenital Heart Disease', 'Aortic Regurgitation']}, 'descriptionModule': {'briefSummary': 'Aortic valve regurgitation (AR) is a common complication following surgery for subaortic stenosis (SAS), yet the long-term outcomes and risk factors for postoperative significant AR (SAR) remain poorly understood. This study aims to investigate the incidence and risk factors of SAR in SAS patients and evaluate the long-term postoperative outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients age from 0-18 underwent SAS surgical repair at Fuwai Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 0-18\n* Clinical diagnosis of subaortic stenosis and underwent surgery\n\nExclusion Criteria:\n\n* Diagnosed with hypertrophic cardiomyopathy\n* Underwent concomitant previous surgical repair for aortic valve or SAS\n* Follow-up time less than 1 year or lack of detailed information.'}, 'identificationModule': {'nctId': 'NCT06751368', 'briefTitle': 'The Fate of Aortic Valve After SAS Surgery in Children', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}, 'officialTitle': 'Aortic Valve Regurgitation After Surgical Repair for Subaortic Stenosis in Children', 'orgStudyIdInfo': {'id': '2022-1727'}}, 'contactsLocationsModule': {'locations': [{'zip': '100069', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pan Xiangbin', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}}}}