Transcatheter Mitral Valvuloplasty Pilot Study

Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation Pilot Study

This study is to evaluate the efficacy and safety of Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation

Inclusion Criteria:

• Significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.
• Age 19 and more
• Written informed consent

Exclusion Criteria:

• Patients who cannot tolerate procedural anticoagulation or post-procedural antiplatelet regimen
• Active endocarditis of the mitral valve
• Rheumatic mitral valve disease
• Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus