Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-03-09 @ 4:02 PM
Study NCT ID:
NCT03104660
Status:
COMPLETED
Last Update Posted:
2020-04-28
First Post:
2017-04-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coronary and Structural Interventions Ulm - Transcatheter Mitral Valve Repair (CSI-Ulm-TMVR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'CE certified mitral valve repair systems'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 355}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-25', 'studyFirstSubmitDate': '2017-04-03', 'studyFirstSubmitQcDate': '2017-04-03', 'lastUpdatePostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cerebral and cardiac events', 'timeFrame': '10 years', 'description': 'Major adverse cerebral and cardiac events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mitral Valve Regurgitation']}, 'referencesModule': {'references': [{'pmid': '30678801', 'type': 'RESULT', 'citation': 'Seeger J, Markovic S, Kessler M, Rottbauer W, Wohrle J. Apixaban After Percutaneous Edge-to-Edge Mitral Valve Repair in Patients With Maintained Sinus Rhythm. JACC Cardiovasc Interv. 2019 Jan 28;12(2):214-216. doi: 10.1016/j.jcin.2018.11.009. No abstract available.'}, {'pmid': '28368846', 'type': 'RESULT', 'citation': 'Seeger J, Muller P, Gonska B, Scharnbeck D, Markovic S, Walcher D, Rottbauer W, Wohrle J. Percutaneous Mitral Valve Repair With the MitraClip in Primary Compared With Secondary Mitral Valve Regurgitation Using the Mitral Valve Academic Research Consortium Criteria. J Invasive Cardiol. 2017 Apr;29(4):145-150.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the long-term results after transcatheter mitral valve repair', 'detailedDescription': 'Patients with transcatheter mitral valve repair are followed for 10 years to demonstrate efficacy and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mitral valve regurgitation\n* transcatheter mitral valve repair\n\nExclusion Criteria:\n\n* no written informed consent'}, 'identificationModule': {'nctId': 'NCT03104660', 'briefTitle': 'Coronary and Structural Interventions Ulm - Transcatheter Mitral Valve Repair (CSI-Ulm-TMVR)', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Coronary and Structural Interventions Ulm - Transcatheter Mitral Valve Repair (CSI-Ulm-TMVR)', 'orgStudyIdInfo': {'id': 'CSI-Ulm-TMVR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CE certified mitral valve repair systems', 'description': 'CE certified transcatheter mitral valve repair systems', 'interventionNames': ['Device: CE certified mitral valve repair systems']}], 'interventions': [{'name': 'CE certified mitral valve repair systems', 'type': 'DEVICE', 'description': 'Patients receive a transcatheter mitral valve repair with CE certified transcatheter mitral repair systems.', 'armGroupLabels': ['CE certified mitral valve repair systems']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'University Hospital Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Jochen Woehrle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Ulm'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jochen Wohrle', 'investigatorAffiliation': 'University of Ulm'}}}}