Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT06655935
Status:
COMPLETED
Last Update Posted:
2024-10-29
First Post:
2024-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Novel Modified Technique for Transcatheter Closure of Secundum Atrial Septal Defect: A Single Center Experience
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006344', 'term': 'Heart Septal Defects, Atrial'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-26', 'studyFirstSubmitDate': '2024-10-16', 'studyFirstSubmitQcDate': '2024-10-22', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recording any complication during transcatheter secundum atrial septal defect closure', 'timeFrame': 'during the procedure', 'description': 'stiff wire can cause perforation or arrhythmias'}], 'secondaryOutcomes': [{'measure': 'assess the duration of the procedure and if this affects the cost of the procedure by any means', 'timeFrame': 'during the procedure'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['atrial septal defects', 'transcatheter closure', 'modified technique'], 'conditions': ['Atrial Septal Defect (ASD)']}, 'descriptionModule': {'briefSummary': 'Transcatheter closure of secundum atrial septal defects is widely approved worldwide, yet it still has multiple risks like perforation and radiation exposure. In this study, we proposed a modified rapid method for closure of secundum atrial septal defects, to avoid material manipulation inside your heart and decrease complication rate.', 'detailedDescription': 'Delivery sheath can be advanced over multipurpose catheter instead of stiff wire'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient with ostium secundum ASD \\& RV volume overload\n\nExclusion Criteria:\n\n* Any other type of atrial septal defects Any other associated congenital anomaly'}, 'identificationModule': {'nctId': 'NCT06655935', 'briefTitle': 'Novel Modified Technique for Transcatheter Closure of Secundum Atrial Septal Defect: A Single Center Experience', 'organization': {'class': 'NETWORK', 'fullName': 'Egyptian Biomedical Research Network'}, 'officialTitle': 'Novel Modified Technique for Transcatheter Closure of Secundum Atrial Septal Defect: A Single Center Experience', 'orgStudyIdInfo': {'id': '36264PR84/2/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '44 patients with ASD who underwent the ordinary transcatheter closure technique using ASO.', 'description': 'The dilator of the Amplatzer delivery sheath of the Amplatzer™ Septal Occluders ASO is advanced over stiff wire into the pulmonary veins', 'interventionNames': ['Procedure: Ordinary Transcatheter ASD closure']}, {'type': 'EXPERIMENTAL', 'label': '36 patients with ASD who underwent the modified transcatheter closure technique using ASO', 'description': 'Amplatzer delivery sheath of the Amplatzer™ Septal Occluders ASO is advanced over the multipurpose catheter to the left atrial cavity', 'interventionNames': ['Procedure: modified transcatheter ASD closure']}], 'interventions': [{'name': 'Ordinary Transcatheter ASD closure', 'type': 'PROCEDURE', 'description': 'deploying the Amplatzer delivery system of the Amplatzer™ Septal Occluders ASO inside the left atrial cavity over stiff wire into the pulmonary veins', 'armGroupLabels': ['44 patients with ASD who underwent the ordinary transcatheter closure technique using ASO.']}, {'name': 'modified transcatheter ASD closure', 'type': 'PROCEDURE', 'description': 'deploying the Amplatzer delivery system of the Amplatzer™ Septal Occluders ASO over the multipurpose catheter inside the left atrial cavity which might help in the shortage of the duration \\& the cost of the procedure with less complication rate', 'armGroupLabels': ['36 patients with ASD who underwent the modified transcatheter closure technique using ASO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82005', 'city': 'Tanta', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Raghda El sheikh, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cardiology departement-Tanta University hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'because of the confidentiality of the patients data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Egyptian Biomedical Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Tanta University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'dr', 'investigatorFullName': 'Nouran Mostafa Mansour', 'investigatorAffiliation': 'Egyptian Biomedical Research Network'}}}}