Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT03488732
Status:
RECRUITING
Last Update Posted:
2019-04-10
First Post:
2018-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Valvular Heart Disease Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012092', 'term': 'Replantation'}], 'ancestors': [{'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-09', 'studyFirstSubmitDate': '2018-03-27', 'studyFirstSubmitQcDate': '2018-04-04', 'lastUpdatePostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '10 years'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular mortality', 'timeFrame': '10 years'}, {'measure': 'NYHA status', 'timeFrame': '10 years'}, {'measure': 'Grade of mitral regurgitation', 'timeFrame': '10 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Valvular Heart Disease']}, 'descriptionModule': {'briefSummary': 'Patients undergoing transcatheter valvular interventions will be prospectively included into the present registry. Baseline, procedural and follow-up data will be collected and analyzed to adress various issues in the field of percutaneous valvular interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing transcatheter valvular interventions', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Severe valvular defect planned for valvular intervention\n\nExclusion Criteria:\n\n\\- No informed consent'}, 'identificationModule': {'nctId': 'NCT03488732', 'briefTitle': 'Valvular Heart Disease Registry', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Valvular Heart Disease Registry - Observational Study of Percutaneous Valvular Interventions', 'orgStudyIdInfo': {'id': 'V1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergonig transcatheter valvular interventions', 'interventionNames': ['Device: Transcatheter valvular repair or replacement']}], 'interventions': [{'name': 'Transcatheter valvular repair or replacement', 'type': 'DEVICE', 'description': 'Transcatheter valvular repair (predominantly MitraClip for mitral regurgitation) or replacement (predominantly transcatheter aortic valve implantation for aortic stenosis)', 'armGroupLabels': ['Patients undergonig transcatheter valvular interventions']}]}, 'contactsLocationsModule': {'locations': [{'city': 'München', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jakob Ledwoch, Dr', 'role': 'CONTACT', 'email': 'jakob.ledwoch@mri.tum.de', 'phone': '+4941402350'}], 'facility': 'Klinik für Innere Medizin I', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}