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Unsuitable anatomy; inoperable patient History of any cognitive or mental health status; pregnant or planning pregnancy; hypersensitivity/contraindication to aspirin, heparin, or Warfarin; hypersensitivity to nitinol or contrast media that cannot be adequately medicated; EF ≤ 25%; life expectancy < 12 months; prior MV intervention (excluding prior surgical MV repair, annuloplasty, or MitraClip not interfering with AltaValve placement) MV surgery; ac
Significant symptomatic MR; high surgical risk; anatomical eligibility Age ≥ 18 years; NYHA II-IV; severe MR; high surgical risk Age > 65; MR ≥3 +; high surgical risk; Life expectancy > 12 months; not eligible for surgery Age ≥ 18 years; SMR ≥ 3+; NYHA ≥ II, amb. IV; GDMT; high surgical risk; suitable for quality-of-life assessment (KCCQ) Age ≥ 18 years; severe MR; NYHA ≥ II, amb. IV; high surgical risk MR ≥ 3 +; NYHA ≥ II, amb. IV; not a mem
Device or Procedural adverse events at 30 days (December 2024) MACE at 30 days (October 2020) Mortality at 1 year (January 2021) Device or procedural major adverse events, MR reduction, and technical success at 30 days (December 2021) Device or procedural adverse events and device malfunction at 30 days (July 2020) HF hospitalization, mortality, CV hospitalization, stroke, and MV reintervention Mortality, disabling stroke, reinte
Recruiting (58) NCT02718001 Recruiting (15) NCT03997305 Not yet recruiting (122) NCT04195984 Recruiting (20) NCT04464876 Active, not recruiting (350) NCT02321514 Recruiting (958) NCT03433274 Recruiting (1600) NCT03242642
Evoque/ Fortis (TS) AltaValve (TA) Mi-thos (TA) SATURN (TA) Tendyne (TA) Intrepid (TA)

