Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-04-25 @ 10:59 AM
Study NCT ID:
NCT02097758
Status:
RECRUITING
Last Update Posted:
2025-02-07
First Post:
2014-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Three Dimensional Transesophageal Echocardiography for Percutaneous Device Closure in Atrial Septal Defect
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2014-03-25', 'studyFirstSubmitQcDate': '2014-03-26', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Complications from device', 'timeFrame': '1 year', 'description': 'migration or dehiscence of device erosion cardiac rupture'}], 'primaryOutcomes': [{'measure': 'Successful device implantation', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Procedure time', 'timeFrame': 'during procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Septal Defect', 'Successful Device Closure']}, 'referencesModule': {'references': [{'pmid': '28633478', 'type': 'DERIVED', 'citation': 'Jang JY, Heo R, Cho MS, Bae J, Hong JA, Lee S, Ahn JM, Park DW, Kim DH, Kang DH, Song JK, Song JM. Efficacy of 3D transoesophageal echocardiography for transcatheter device closure of atrial septal defect without balloon sizing. Eur Heart J Cardiovasc Imaging. 2018 Jun 1;19(6):684-689. doi: 10.1093/ehjci/jex153.'}]}, 'descriptionModule': {'briefSummary': 'Background: Three-dimensional echocardiographic image for atrial septal defect (ASD) is useful for evaluation of defect size and shape. The investigators suggested optimal device size using three-dimensional transesophageal echocardiographic image and our formula in previous study.\n\nPurpose: In this study, the investigators seek to predict the correct device size and confirm the accuracy of the formula that we made before device closure in ASD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 year-old\n* Susceptible indication for atrial septal defect closure\n* Potential candidate for device closure\n\nExclusion Criteria:\n\n* Poor candidate for device closure: multiple ASDs, ect\n* Other heart disease requiring open heart surgery'}, 'identificationModule': {'nctId': 'NCT02097758', 'acronym': 'ASD', 'briefTitle': 'Efficacy of Three Dimensional Transesophageal Echocardiography for Percutaneous Device Closure in Atrial Septal Defect', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'orgStudyIdInfo': {'id': 'ASD_3D_device size'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'transcatheter device closure', 'description': 'Choosing device size using three dimensional image and the formula without sizing balloon', 'interventionNames': ['Device: Transcatheter device closure']}], 'interventions': [{'name': 'Transcatheter device closure', 'type': 'DEVICE', 'description': 'Closure of atrial septal defect with device\n\n* choosing device size with 3D image and the formula\n* we do not use sizing balloon for choosing of the device size', 'armGroupLabels': ['transcatheter device closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jong-Min Song, MD,PhD', 'role': 'CONTACT', 'email': 'jmsong@amc.seoul.kr', 'phone': '+82-2-3010-3168'}, {'name': 'Jeong Yoon Jang, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jong-Min Song, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jong-Min Song, MD,PhD', 'role': 'CONTACT', 'email': 'jmsong@amc.seoul.kr', 'phone': '+82-2-3010-3168'}], 'overallOfficials': [{'name': 'Jong-Min Song, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jong-Min Song', 'investigatorAffiliation': 'Asan Medical Center'}}}}