Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-03-05 @ 12:53 PM
Study NCT ID:
NCT00229827
Status:
TERMINATED
Last Update Posted:
2012-03-16
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Timing for Repair of Left to Right Shunt Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006345', 'term': 'Heart Septal Defects, Ventricular'}, {'id': 'D004694', 'term': 'Endocardial Cushion Defects'}], 'ancestors': [{'id': 'D006343', 'term': 'Heart Septal Defects'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'whyStopped': 'sufficient data was collected', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-14', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-28', 'lastUpdatePostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-30', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['pediatric health', 'cardiac', 'pediatric population', 'congenital heart surgery', 'left to right shunt lesions', 'heart surgery', 'Atrioventricular canal defects'], 'conditions': ['Ventricular Septal Defects', 'Persistent Common Atrioventricular Canal']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the optimal timing for repair of left-to-right shunt lesions such as ventricular septal defects and atrioventricular canals.', 'detailedDescription': 'In the past, children with left-to-right shunt lesions such as ventricular septal defects and atrioventricular canal defects were palliated with a pulmonary artery band. This prevented injury to the pulmonary vasculature while the child grew to a size where complete repair could be undertaken. With the improvements in surgical technique and critical care, there is a push to do a primary complete repair for these defects at younger and younger ages. These operations should be delayed as long as possible to allow for growth but not so long that there is unnecessary heart failure and medication requirements. The primary aim is to determine the optimal timing for repair of left-to-right shunt lesions such as ventricular septal defects and atrioventricular canals. The secondary aim is to define the criteria for failing medical anti-congestive heart failure therapy. This study will be conducted through a retrospective chart review.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in the congenital surgery database\n\n* Patients who have undergone repair of ventricular septal defects\n* Patients who have undergone repair of atrioventricular canal defects', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in the congenital surgery database\n* Patients who have undergone repair of ventricular septal defects\n* Patients who have undergone repair of atrioventricular canal defects'}, 'identificationModule': {'nctId': 'NCT00229827', 'briefTitle': 'Optimal Timing for Repair of Left to Right Shunt Lesions', 'organization': {'class': 'OTHER', 'fullName': "Children's Healthcare of Atlanta"}, 'officialTitle': 'Optimal Timing for Repair of Left-to-Right Shunt Lesions', 'orgStudyIdInfo': {'id': '05-092'}}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta at Egleston", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Brian Kogon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Healthcare of Atlanta", 'class': 'OTHER'}}}}