Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study
Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study
Study to evaluate the safety and performance of the Twelve TMVR System
The study is a prospective, multi-center, non-randomized trial to evaluate the safety and
 performance of the Twelve TMVR System in very high risk patients with severe, symptomatic
 mitral regurgitation.
Key Inclusion Criteria:

 -  Severe mitral regurgitation (MR Grade 3-4+)

 -  Symptomatic mitral regurgitation (NYHA Class II-IV)

 -  Trans-apical access deemed feasible by the treating physician

 -  Native mitral valve geometry and size compatible with the Twelve TMVR

 Key Exclusion Criteria:

 -  Left ventricular ejection fraction (LVEF) < 20

 -  Evidence of intracardiac mass, thrombus, or vegetation

 -  Prior valve surgery or need for other valve surgery

 -  Prior stroke within 4 weeks

 -  Need for coronary revascularization

 -  History of, or active, endocarditis

 -  Renal insufficiency (Creatinine > 2.5 mg/dL)