Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-02-03 @ 2:21 AM
Study NCT ID:
NCT01929733
Status:
COMPLETED
Last Update Posted:
2013-08-28
First Post:
2013-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Results of 450 Percutaneous Closures of PDA in a Single Center
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004374', 'term': 'Ductus Arteriosus, Patent'}], 'ancestors': [{'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': {'type': 'ACTUAL', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-21', 'studyFirstSubmitDate': '2013-08-14', 'studyFirstSubmitQcDate': '2013-08-21', 'lastUpdatePostDateStruct': {'date': '2013-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Early and late Adverse effects', 'timeFrame': 'one day, 10 days and a year after PDA closure and then last check-up exam', 'description': 'hemolysis, bleeding, infections ect. due to the fact that the research is retrospective and refers to a period of 15 years (1998-2013)and the fact that some patients had a check-up exam from time to time - the investigators have decided to include in this research the last check-up exam as well.'}], 'primaryOutcomes': [{'measure': 'Success of implantation', 'timeFrame': 'one day, 10 days and a year after PDA closure and then last check-up exam', 'description': 'due to the fact that the research is retrospective and refers to a period of 15 years (1998-2013)and the fact that some patients had a check-up exam from time to time - the investigators have decided to include in this research the last check-up exam as well.'}], 'secondaryOutcomes': [{'measure': 'residual shunt', 'timeFrame': 'one day, 10 days and a year after PDA closure and then last check-up exam', 'description': 'due to the fact that the research is retrospective and refers to a period of 15 years (1998-2013) and the fact that some patients had a check-up exam from time to time - the investigators have decided to include in this research the last check-up exam as well.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Patent Ductus Arteriosus'], 'conditions': ['Patent Ductus Arteriosus']}, 'descriptionModule': {'briefSummary': "Percutaneous closure is one of the methods used to treat, among other congenital heart disorder, Persistent Ductus Arteriosus (PDA) in children and adults. During the years 1998-2013 four hundred and fifty patients were catheterized in the department of pediatric cardiology and congenital heart diseases in Rambam health care campus, using various devices.\n\nIn this retrospective research, the investigators analyze data from patients' medical files, to estimate and define the correlation between the patients' demographic and morphologic data to the type and size of chosen closure device.\n\nAim of study:\n\nTo create an algorithm that can be used to choose the proper device for percutaneous closure of the PDA, based on the characteristics of the patient and the PDA type.", 'detailedDescription': "The investigators analyze the demographic characteristics of patients before the procedure (Age, gender, weight, height, co-morbidities etc.), the type and characteristics of PDA and the chosen device, success and failure rates of the procedure, and adverse effects.\n\nThe data is taken from patients' medical files - based on medical reports regarding physical examination, blood tests and imaging studies including cineangiograms and echo-doppler studies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the patients that underwent percutaneous closure of PDA between January 1998 and august 2013 in the department of pediatric cardiology and congenital heart diseases in Rambam health care campus', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All the patients that underwent percutaneous closure of PDA between January 1998 and august 2013 in the department of pediatric cardiology and congenital heart diseases in Rambam health care campus\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01929733', 'briefTitle': 'Long Term Results of 450 Percutaneous Closures of PDA in a Single Center', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Long Term Results of 450 Percutaneous Closures of PDA in a Single Center', 'orgStudyIdInfo': {'id': '0192-13'}}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'RAMBAM health care center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Moshe Dotan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}, {'name': 'Omer Ephrat', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}