Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 9:46 PM
Study NCT ID:
NCT04395027
Status:
WITHDRAWN
Last Update Posted:
2022-12-08
First Post:
2020-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iatrogenic Atrial Septal Defect Study (iASD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Administratively closed with IRB', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-06', 'studyFirstSubmitDate': '2020-05-15', 'studyFirstSubmitQcDate': '2020-05-15', 'lastUpdatePostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival', 'timeFrame': '6 month', 'description': 'Survival at 6 months'}], 'secondaryOutcomes': [{'measure': 'survival', 'timeFrame': '1 year', 'description': 'survival at 1 year'}, {'measure': 'Freedom from heart failure hospitalization', 'timeFrame': '1 year', 'description': 'Heart failure hospitalizations at 1 year'}, {'measure': 'NYHA Functional Class', 'timeFrame': '1 year', 'description': 'Symptom status at 1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['mitral valve intervention', 'iatrogenic septal defect'], 'conditions': ['Septal Defect, Atrial']}, 'descriptionModule': {'briefSummary': 'This is an open-label, randomized, controlled trial of iatrogenic atrial septal defect closure with the an atrial septal occluder versus usual care observation in patients post-mitral valve intervention requiring large bore transspetal access.', 'detailedDescription': 'This study is an open label, prospective, multicenter, non-randomized single-arm study to evaluate the safety and efficacy of the closing iatrogenic atrial septal defects in patients undergoing transcatheter mitral valve procedures using large sheaths.\n\nA maximum of 5 Clinical Sites (referred to as "Sites" in the remainder of this document) in the U.S. Two hundred and ten patients will be enrolled in this study. The patients will randomized 1:2 device: control. The anticipated accrual rate is approximately 20 Subjects per month for a total accrual period of approximately 12-18 months.\n\nPatients may be enrolled into the study provided all inclusion and no exclusion criteria are met as specified in Section 4. Subjects will be evaluated through hospital discharge and return for follow-up visits at 30 days, 6 months, and 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 at the time of informed consent signature.\n2. Capable of complying with Protocol requirements, including follow-up.\n3. An Informed Consent Form signed by Subject or legal representative.\n4. Patient has had successful reduction of mitral regurgitation to at most moderate regurgitation post-mitral-clip.\n\nExclusion Criteria:\n\n1. Remaining mitral regurgitation of ≥ moderate-severe\n2. Subject unable or unwilling to provide informed consent\n3. Concomitant severe aortic valve disease\n4. Dialysis\n5. Pregnancy or intent to become pregnant\n6. Life expectancy \\< 1 year\n7. Active bleeding\n8. Inability to follow up with 6-month timepoint due logistical concerns'}, 'identificationModule': {'nctId': 'NCT04395027', 'acronym': 'iASD', 'briefTitle': 'Iatrogenic Atrial Septal Defect Study (iASD)', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Iatrogenic Atrial Septal Defect Study', 'orgStudyIdInfo': {'id': '13708'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'These patients will not have their iatrogenic septal defect closed.'}, {'type': 'EXPERIMENTAL', 'label': 'Device', 'description': 'These patients will have their iatrogenic septal defect closed after the mitral intervention is completed.', 'interventionNames': ['Device: atrial septal defect closure']}], 'interventions': [{'name': 'atrial septal defect closure', 'type': 'DEVICE', 'description': 'The iatrogenic septal defect will be closed in the usual manner', 'armGroupLabels': ['Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Marvin Eng', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Marvin Eng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henry Ford Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Staff', 'investigatorFullName': 'Tiberio Frisoli', 'investigatorAffiliation': 'Henry Ford Health System'}}}}