Brief Title
Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.
Official Title
Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation
Brief Summary
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.
Study Type
Interventional
Primary Outcome
Death from any cause and heart failure hospitalization
Secondary Outcome
Death from any cause
Condition
Aortic Stenosis
Intervention
Mitral Valve Clipping
Study Arms / Comparison Groups
TAVI
Description: Transfemoral transcatheter aortic valve implantation plus optimal standard of care medical therapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
1162
Start Date
December 1, 2019
Completion Date
August 1, 2023
Primary Completion Date
August 1, 2023
Eligibility Criteria
Inclusion criteria - Planned transfemoral TAVI using an Edwards Sapien 3 Transcatheter Heart Valve (or subsequent models) - Moderate to severe mitral regurgitation - Symptom status NYHA II-III - Treatment and compliance with optimal, individually-tailored guideline directed medical therapy for heart failure for at least 30 days before inclusion - Age ≥ 18 and < 90 years - Written informed consent Exclusion criteria - MR mechanism/anatomy precluding MitraClip therapy - Groin blood vessels are not eligible for TAVI procedure - Massive or torrential tricuspid regurgitation - Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen. - Life expectancy < 1 year due to non-cardiac conditions - LVEF ≤ 25% - Hypotension (systolic pressure < 90 mmHg) or requirement of inotropic support or mechanical hemodynamic support - Cardiomyopathy other than dilated cardiomyopathy - Fixed pulmonary artery systolic pressure > 70 mm Hg - Any prior mitral valve surgery or transcatheter mitral valve procedure - Stroke or transient ischemic event within 6 months prior to randomization - Severe symptomatic carotid stenosis - Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter defibrillator within 90 days prior to randomization - Untreated clinically significant coronary artery disease requiring revascularization - Any percutaneous cardiac intervention or carotid surgery within the 30 days prior to randomization, or any cardiac surgery within six months prior to randomization. - Need for any other cardiovascular surgery (other than MV or AV disease) - Echocardiographic evidence of intracardiac mass, thrombus, or vegetation - Active endocarditis or active infections requiring current antibiotic treatment - Any condition making it unlikely that the patient will be able to complete all protocol procedures - Patient unable to provide written informed consent prior to study enrolment - Pregnant or nursing women - Women of child bearing potential - Current participation in any other interventional clinical trial - Patients under legal supervision or guardianship Patients placed in an institution by official or court order
Gender
All
Ages
18 Years - 89 Years
Accepts Healthy Volunteers
No
Contacts
Axel Linke, MD, +49 351 4501704, [email protected]
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT04009434
Organization ID
MITAVI
Responsible Party
Sponsor
Study Sponsor
Technische Universität Dresden
Collaborators
KKS Dresden
Study Sponsor
Axel Linke, MD, Principal Investigator, Technische Universitaet Dresden, HEART CENTER
Verification Date
February 2020