Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.

Study Overview
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Brief Summary
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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.

Official Title
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Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation

Conditions
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Aortic Stenosis, Mitral Regurgitation

Intervention / Treatment
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* Device: Mitral Valve Clipping
* Device: TAVI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TAVI<br>Transfemoral transcatheter aortic valve implantation plus optimal standard of care medical therapy | Device: TAVI<br>* Transfemoral transcatheter aortic valve implantation plus optimal standard of care therapy.<br>|
| Experimental: TAVI/MitraClip<br>Transfemoral transcatheter aortic valve implantation, mitral valve clipping plus optimal standard of care medical therapy. | Device: Mitral Valve Clipping<br>* Patients receive treatment for mitral regurgitation with mitral valve clipping including standard drug therapy.<br>Device: TAVI<br>* Transfemoral transcatheter aortic valve implantation plus optimal standard of care therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death from any cause and heart failure hospitalization | Composite endpoint of time to heart failure hospitalization or death from any cause | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death from any cause | Time from randomization to death from any cause | 1, 2, 3, 4 years | 
| Need for mitral valve reintervention | Need for mitral valve reintervention | 1, 2, 3, 4 years | 
| Mitral regurgitation severity | Mitral regurgitation severity at 12 months | 1 year | 
| 6 Minute Walk Test | Change in 6 Minute Walk Test at 12 months | 1 year | 
| New York Heart Association Functional Class | Course of New York Heart Association (NYHA) Functional Class at 1, 3, 6 months and 1, 2, 3, 4 years | 1, 3, 6 months and 1, 2, 3, 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Stenosis, Aortic Disease, Transcatheter Aortic Valve Implantation, Mitral Regurgitation, Mitral Valve Regurgitation, Mitral Disease, Mitral valve clipping, MitraClip, Heart Valve Diseases