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Exclusion Criteria Stroke/TIA (3 months) or Modified Rankin Scale ≥ 4 disability; AMI (30 days); heart valve surgery or TC MV intervention; percutaneous CV intervention, CV surgery, or carotid surgery (30 days); rheumatic heart disease or endocarditis (3 months); hypertrophic/restrictive cardiomyopathy, constrictive pericarditis, or any HF cause other than dilated cardiomyopathy; inferior vena cava filter or atrial septal device; clinically signi

mL/min/1.73 m 2 unsuitable anatomy days) active endocarditis; creatinine > 2.5 mg/dL

Age ≥ 18 years; NYHA II, III or amb. IV; MR 3-4 +; GDMT and/or CRT; high surgical risk; TEE feasible; anatomical eligibility; suitable for femoral access procedure and TS catheterization ≥ 18 years; severe MR; Cardiac Index > 2.0; EF ≥ 30%; NYHA II, III or amb. IV; GDMT (30 days); high surgical risk IV; GDMT; surgical high-risk; anatomical eligibility; DMR: EROA ≥ 40 mm 2 or regurgitant Vol. ≥ 60 mL; SMR: EROA > 30 mm 2 or regurgitan

Table 1. Ongoing active clinical trials investigating transcatheter mitral valve replacement devices*
Inclusion Criteria NCT03813524 and NCT03958773: 85 > age Age ≥ 18 years; MR ≥ 3 +; NYHA II, III, amb. Age ≥ 18 years; severe MR; high surgical risk; risk; anatomical eligibility; NYHA III or IV HF Age ≥ 18 years; severe MR; NYHA II, III, IVa

Primary Outcome (Primary Completion) Mortality, MACE, hospitalization, and device or procedural serious adverse events (15 December 2020) Technical success and major device related adverse events (30 days) (April 2022) Major device related adverse events (30 days) (12 September 2020) MACE at 30 days (July 2021) MACE and device safety at 30 days (April 2021) Major adverse events at 30 days (July 2021) MACE, all-cause mortality,

Status (patients) Recruiting (30) NCT03339115 Recruiting (15) NCT03813524 Recruiting (10) NCT03958773 Recruiting (50) NCT02974881 Not yet recruiting (15) NCT04029337 Recruiting (50) NCT04029363 Active, not recruiting (115) NCT03039855 Active, not recruiting (30) NCT02276547 Active, not recruiting (20) NCT02768402 Active, not recruiting (75) NCT03661398 Active, not recruiting (10) NCT02428010

Device (Access) Cardiovalve (TS) HighLife (TS) Tiara (TA) Caisson (TS) Twelve (TA)