Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment.
Age ≥ 18 years
Severe mitral regurgitation
New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
Patient is under maximally tolerated GDMT (incl. CRT) for at least 3 months
Mitral stenosis
Rheumatic valve disease
Severe calcifications of the mitral annulus and/or mitral leaflets
Prior surgical or interventional treatment of the mitral valve