Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT04303793
Status:
UNKNOWN
Last Update Posted:
2020-03-11
First Post:
2020-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Procedural Outcomes of Percutaneous PDA Closure: Comparative Study Between Different Devices.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2020-03-07', 'studyFirstSubmitQcDate': '2020-03-09', 'lastUpdatePostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedural safety', 'timeFrame': 'one month', 'description': 'studying the occurrence of catheter related complications including\n\n1. Occurrence of vascular access hematoma(Yes/No )\n2. Occurrence of contrast induced nephropathy (Yes/No)\n3. PDA closure Device embolization (Yes/No)\n4. Cardiac tamponade (Yes/No)'}, {'measure': 'Procedural efficacy', 'timeFrame': 'one month', 'description': 'timing of complete closure of the PDA with no residual shunts\n\n1. Residual left to right shunt (Yes/No)\n2. Degree of the residual shunt (Trace, Mild , Moderate, severe)\n3. Timing of closure of the shunt( immediately postprocedural, 24 hours post procedural , 1 month post procedural )'}, {'measure': 'Procedural outcomes', 'timeFrame': 'one month', 'description': 'comparison of echocardiography data that will be done pre catheter closure, one day post procedure and one month later ( left ventricular and atrial dimensions-left ventricular ejection fraction-pulmonary artery systolic pressure- degree of tricuspid regurge)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congenital Heart Disease']}, 'descriptionModule': {'briefSummary': 'To compare safety, efficacy and procedural outcome of percutaneous PDA closure using different approaches for better characterization of device selection criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* all patients who are candidate for transcatheter PDA closure\n\nExclusion Criteria:\n\n1. Patients with PDA dependent pulmonary circulation.\n2. Patients with small sized PDA which is silent by auscultation\n3. Patients with large sized PDA which is unsuitable for Trans-catheter closure\n4. Patients with PDA and severe irreversible pulmonary hypertension (Eisenmenger's syndrome) (7).\n5. Patients with active infection or active infective endarteritis.\n6. Patients refusing the study."}, 'identificationModule': {'nctId': 'NCT04303793', 'briefTitle': 'Procedural Outcomes of Percutaneous PDA Closure: Comparative Study Between Different Devices.', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Procedural Outcomes of Percutaneous PDA Closure: Comparative Study Between Different Devices.', 'orgStudyIdInfo': {'id': 'congenital heart disease'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Percutaneous PDA closure', 'type': 'DEVICE', 'description': 'transcatheter patent ductus arteriosus closure'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed Mohamed Moheb El-Din', 'role': 'CONTACT', 'email': 'ahmedmoheb34567@gmail.com', 'phone': '01060964666'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of cardiovascular medicine', 'investigatorFullName': 'Ahmed Mohamed Moheb El-Din', 'investigatorAffiliation': 'Assiut University'}}}}