Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-28 @ 5:09 PM
Study NCT ID:
NCT04009434
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2019-07-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1162}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-03', 'studyFirstSubmitDate': '2019-07-03', 'studyFirstSubmitQcDate': '2019-07-03', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of patients with AEs, SAEs.', 'timeFrame': '1, 2, 3, 4 years'}], 'primaryOutcomes': [{'measure': 'Death from any cause and heart failure hospitalization', 'timeFrame': '1 year', 'description': 'Composite endpoint of time to heart failure hospitalization or death from any cause'}], 'secondaryOutcomes': [{'measure': 'Death from any cause', 'timeFrame': '1, 2, 3, 4 years', 'description': 'Time from randomization to death from any cause'}, {'measure': 'Need for mitral valve reintervention', 'timeFrame': '1, 2, 3, 4 years', 'description': 'Need for mitral valve reintervention'}, {'measure': 'Mitral regurgitation severity', 'timeFrame': '1 year', 'description': 'Mitral regurgitation severity at 12 months'}, {'measure': '6 Minute Walk Test', 'timeFrame': '1 year', 'description': 'Change in 6 Minute Walk Test at 12 months'}, {'measure': 'New York Heart Association Functional Class', 'timeFrame': '1, 3, 6 months and 1, 2, 3, 4 years', 'description': 'Course of New York Heart Association (NYHA) Functional Class at 1, 3, 6 months and 1, 2, 3, 4 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aortic Stenosis', 'Aortic Disease', 'Transcatheter Aortic Valve Implantation', 'Mitral Regurgitation', 'Mitral Valve Regurgitation', 'Mitral Disease', 'Mitral valve clipping', 'MitraClip', 'Heart Valve Diseases'], 'conditions': ['Aortic Stenosis', 'Mitral Regurgitation']}, 'descriptionModule': {'briefSummary': 'To evaluate whether patients after successful transfemoral transcatheter aortic valve implantation (TAVI), who have concomitant, moderate to severe mitral regurgitation (MR) benefit from an additional treatment of this valve disease as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Planned transfemoral TAVI using an Edwards Sapien 3 Transcatheter Heart Valve (or subsequent models)\n* Moderate to severe mitral regurgitation\n* Symptom status NYHA II-III\n* Treatment and compliance with optimal, individually-tailored guideline directed medical therapy for heart failure for at least 30 days before inclusion\n* Age ≥ 18 and \\< 90 years\n* Written informed consent\n\nExclusion criteria\n\n* MR mechanism/anatomy precluding MitraClip therapy\n* Groin blood vessels are not eligible for TAVI procedure\n* Massive or torrential tricuspid regurgitation\n* Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen.\n* Life expectancy \\< 1 year due to non-cardiac conditions\n* LVEF ≤ 25%\n* Hypotension (systolic pressure \\< 90 mmHg) or requirement of inotropic support or mechanical hemodynamic support\n* Cardiomyopathy other than dilated cardiomyopathy\n* Fixed pulmonary artery systolic pressure \\> 70 mm Hg\n* Any prior mitral valve surgery or transcatheter mitral valve procedure\n* Stroke or transient ischemic event within 6 months prior to randomization\n* Severe symptomatic carotid stenosis\n* Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter defibrillator within 90 days prior to randomization\n* Untreated clinically significant coronary artery disease requiring revascularization\n* Any percutaneous cardiac intervention or carotid surgery within the 30 days prior to randomization, or any cardiac surgery within six months prior to randomization.\n* Need for any other cardiovascular surgery (other than MV or AV disease)\n* Echocardiographic evidence of intracardiac mass, thrombus, or vegetation\n* Active endocarditis or active infections requiring current antibiotic treatment\n* Any condition making it unlikely that the patient will be able to complete all protocol procedures\n* Patient unable to provide written informed consent prior to study enrolment\n* Pregnant or nursing women\n* Women of child bearing potential\n* Current participation in any other interventional clinical trial\n* Patients under legal supervision or guardianship Patients placed in an institution by official or court order'}, 'identificationModule': {'nctId': 'NCT04009434', 'acronym': 'MITAVI', 'briefTitle': 'Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation', 'orgStudyIdInfo': {'id': 'MITAVI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'TAVI', 'description': 'Transfemoral transcatheter aortic valve implantation plus optimal standard of care medical therapy', 'interventionNames': ['Device: TAVI']}, {'type': 'EXPERIMENTAL', 'label': 'TAVI/MitraClip', 'description': 'Transfemoral transcatheter aortic valve implantation, mitral valve clipping plus optimal standard of care medical therapy.', 'interventionNames': ['Device: Mitral Valve Clipping', 'Device: TAVI']}], 'interventions': [{'name': 'Mitral Valve Clipping', 'type': 'DEVICE', 'description': 'Patients receive treatment for mitral regurgitation with mitral valve clipping including standard drug therapy.', 'armGroupLabels': ['TAVI/MitraClip']}, {'name': 'TAVI', 'type': 'DEVICE', 'description': 'Transfemoral transcatheter aortic valve implantation plus optimal standard of care therapy.', 'armGroupLabels': ['TAVI', 'TAVI/MitraClip']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stephan Haussig, MD', 'role': 'CONTACT', 'phone': '+493514501704'}], 'facility': 'Heart-Center Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'centralContacts': [{'name': 'Axel Linke, MD', 'role': 'CONTACT', 'email': 'mitavi@mailbox.tu-dresden.de', 'phone': '+49 351 4501704'}, {'name': 'Stephan Haussig, MD', 'role': 'CONTACT', 'email': 'mitavi@mailbox.tu-dresden.de', 'phone': '+49 351 4501704'}], 'overallOfficials': [{'name': 'Axel Linke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technische Universitaet Dresden, HEART CENTER'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'After publication of the primary objective, the data might be provided to interested scientists on request (e.g. for meta-analyses, health related registers or other scientific questions) in an anonymized way within five years, if the members of the MITAVI-trial group agree.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zentrum für Klinische Studien Leipzig', 'class': 'OTHER'}, {'name': 'University Medical Center Mainz', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}