Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-27 @ 2:38 AM
Study NCT ID:
NCT07132593
Status:
COMPLETED
Last Update Posted:
2025-08-20
First Post:
2025-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective, Observational, and Descriptive Study of Pediatric Cardiac Fibroma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006338', 'term': 'Heart Neoplasms'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-17', 'studyFirstSubmitDate': '2025-08-08', 'studyFirstSubmitQcDate': '2025-08-17', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'composite endpoint', 'timeFrame': 'up to 5 years', 'description': 'all-cause mortality or cardiac reoperation'}], 'secondaryOutcomes': [{'measure': 'ventricular failure', 'timeFrame': 'up to 5 years', 'description': 'left ventricular ejection fraction (LVEF) \\< 55% or right ventricular fractional area change (RVFAC) \\< 45% by echocardiography'}, {'measure': 'ventricular aneurysm', 'timeFrame': 'up to 5 years', 'description': 'newly formed segmental dyskinesia with localized dilation'}, {'measure': 'malignant arrhythmia', 'timeFrame': 'up to 5 years', 'description': 'sustained ventricular tachycardia, ventricular fibrillation, or frequent polymorphic premature ventricular contractions requiring medical intervention'}, {'measure': 'Heart block', 'timeFrame': 'up to 5 years', 'description': 'any new onset of high-degree atrioventricular block (Mobitz II or complete AVB), as well as complete left bundle branch block (CLBBB) by ECG'}, {'measure': 'severe perioperative complications', 'timeFrame': 'before discharge', 'description': 'including low cardiac output syndrome \\[cardiac index \\< 2.0 L/(min·m2)\\], delayed sternal closure, prolonged invasive mechanical ventilation (≥ 7 days) and need for extra-corporeal membrane oxygenation (ECMO)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['congenital heart disease', 'cardiac tumor', 'surgical technique'], 'conditions': ['Cardiac Tumor']}, 'descriptionModule': {'briefSummary': 'This study was a retrospective descriptive case series analyzing outcomes of a novel surgical approach This study aimed to evaluate a modified surgical technique-called the Sandwich Procedure-for reconstructing the heart after resection of cardiac fibromas in children. Cardiac fibroma is a rare benign tumor that can compress vital cardiac structures and cause serious symptoms such as arrhythmia, heart failure, or obstruction of blood flow. Surgical removal is often required, but large tumors may leave defects in the heart wall that are challenging to repair, especially in young children.\n\nThe Sandwich Procedure was developed at our institution to improve the strength and stability of heart wall reconstruction after tumor removal. It involves suturing two layers of treated biological tissue-both inside and outside the heart wall-to restore normal shape and function, while minimizing the risk of complications like aneurysm or bleeding. This retrospective, observational study includes pediatric patients who underwent this procedure between 2018 and 2023. We report on its surgical feasibility, short- and mid-term outcomes, and potential benefits in preserving cardiac function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients underwent cardiac fibroma resection followed by ventricular reconstruction with the Sandwich Procedure at our institution', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* underwent cardiac tumor resection\n* underwent ventricular reconstruction with the Sandwich Procedure\n\nExclusion Criteria:\n\n* the final pathological diagnosis indicated other than cardiac fibroma\n* the final pathological diagnosis indicated metastatic tumors\n* incomplete clinical or follow-up data'}, 'identificationModule': {'nctId': 'NCT07132593', 'briefTitle': 'A Retrospective, Observational, and Descriptive Study of Pediatric Cardiac Fibroma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'A Retrospective, Observational, and Descriptive Study of Pediatric Cardiac Fibroma', 'orgStudyIdInfo': {'id': 'T2024-ZX007-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgical group', 'description': 'Patients underwent cardiac fibroma resection and following ventricular reconstruction with the Sandwich Procedure.', 'interventionNames': ['Procedure: ventricular reconstruction']}], 'interventions': [{'name': 'ventricular reconstruction', 'type': 'PROCEDURE', 'description': 'The Sandwich Procedure was developed at our institution to improve the strength and stability of heart wall reconstruction after tumor removal. It involves suturing two layers of treated biological tissue-both inside and outside the heart wall-to restore normal shape and function, while minimizing the risk of complications like aneurysm or bleeding.', 'armGroupLabels': ['Surgical group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Pediatric Cardiac Surgery Center, Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data underlying this article cannot be shared publicly for the privacy of individuals that participated in the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}