Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-04-14 @ 10:53 AM
Study NCT ID:
NCT06526403
Status:
COMPLETED
Last Update Posted:
2024-07-29
First Post:
2024-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Echocardiography-guided Oval-shaped ASD Closure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Zero-fluoroscopy oval-shaped secundum ASD closure'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-26', 'studyFirstSubmitDate': '2024-07-23', 'studyFirstSubmitQcDate': '2024-07-26', 'lastUpdatePostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate', 'timeFrame': 'five years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ASD II', 'Percutaneous Closure', 'Zero-fluoroscopy']}, 'descriptionModule': {'briefSummary': 'Background: An atrial septal defect (ASD) is considered oval-shaped when its shortest diameter is less than 75% of its longest diameter. Research on the percutaneous closure of oval-shaped ASDs is limited, and to our knowledge, there are no reports of non-fluoroscopic closure for this specific population.\n\nObjective: To assess the effectiveness of non-fluoroscopic percutaneous closure for oval-shaped ASDs.\n\nMethods: This single-center, retrospective study examines patients undergoing percutaneous closure of oval-shaped ASDs using a non-fluoroscopy technique for initial decision-making. The device was selected to be approximately 0-4 mm larger than the longest diameter of the defect, based on measurements from transthoracic and transesophageal ultrasound.', 'detailedDescription': 'Background: An atrial septal defect (ASD) is considered oval-shaped when its shortest diameter is less than 75% of its longest diameter. Research on the percutaneous closure of oval-shaped ASDs is limited, and to our knowledge, there are no reports of non-fluoroscopic closure for this specific population.\n\nObjective: To assess the effectiveness of non-fluoroscopic percutaneous closure for oval-shaped ASDs.\n\nMethods: This single-center, retrospective study examines patients undergoing percutaneous closure of oval-shaped ASDs using a non-fluoroscopy technique for initial decision-making. The device was selected to be approximately 0-4 mm larger than the longest diameter of the defect, based on measurements from transthoracic and transesophageal ultrasound.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Oval-shaped secundum ASD with evidence of right ventricular overload, no significant and irreversible pulmonary arterial hypertension, no significant arrhythmia, no serious problems in other organs, and presumption of appropriate rims for device implantation\n\nExclusion Criteria:\n\n* Other than stated in inclusion criteria'}, 'identificationModule': {'nctId': 'NCT06526403', 'briefTitle': 'Echocardiography-guided Oval-shaped ASD Closure', 'organization': {'class': 'OTHER', 'fullName': 'National Cardiovascular Center Harapan Kita Hospital Indonesia'}, 'officialTitle': 'Echocardiography-Guided Percutaneous Closure of Oval-Shaped Secundum Atrial Septal Defects', 'orgStudyIdInfo': {'id': 'LB.02.01/VII/020/KEP020/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zero fluoroscopy oval-shaped secundum ASD closure', 'interventionNames': ['Device: Zero-fluoroscopy ASD closure']}], 'interventions': [{'name': 'Zero-fluoroscopy ASD closure', 'type': 'DEVICE', 'description': 'Percutaneous ASD closure without fluoroscopy was performed in secundum-type oval-shaped ASD', 'armGroupLabels': ['Zero fluoroscopy oval-shaped secundum ASD closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11420', 'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'National Cardiovascular Center Harapan Kita', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cardiovascular Center Harapan Kita Hospital Indonesia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}