Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
Age ≥ 18 years
Moderate-severe or severe mitral regurgitation (≥ 3+)
Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
Patient is under guideline directed medical therapy for at least one month, as reviewed and confirmed by the local multidisciplinary Heart Team
Any stroke/TIA within 30 days
Severe symptomatic carotid stenosis (> 70% by non-invasive imaging)
Active infections requiring antibiotic therapy
Active ulcer or gastro-intestinal bleeding in the past 3 months