Tiny valve repair device tested in first human trial for leaky heart

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 19 years 2. Moderate to severe (≥3+) or severe (≥4+) degenerative mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines, depicted in Figure 14) 3. New York Heart Association (NYHA) Functional Class II, III, or Ambulatory (IV) 4. Elevated risk for surgical mitral valve repair: Society of Thoracic Surgery (STS) predicted risk of mortality (PROM) of ≥6% as determined by the STS Risk Calculator for Surgical Repair of Primary Mitral Regurgitation \[1\], as well as patient operative risk assessment by the Heart Team 5. Suitable anatomy for the Vesalius TMVr System as determined by pre-procedure imaging 6. Willing to adhere to study follow-up schedule for up to 5 years 7. Written informed consent provided Exclusion Criteria: 1. Anatomy ideally suitable for other approved transcatheter therapy (i.e. TEER candidate) 2. LV ejection fraction \< 30% 3. Active bacterial endocarditis within 60 days of planned index procedure 4. Dialysis-dependent renal insufficiency 5. Body Mass Index (BMI) ≥ 45 kg/m2 6. Previous valvular surgery 7. Previous atrial septal surgery 8. Previous endovascular structural procedure(s) and/or device(s) within 6 months 9. Severe mitral annular calcification (MAC) prohibiting device implantation 10. Severe annulus or leaflet calcification 11. Leaflet perforation 12. Contraindication to anticoagulation / antiplatelet therapy 13. Patients with sensitivity to nickel or contrast media 14. Concomitant severe tricuspid regurgitation 15. Absence of conventional medial and lateral papillary muscle groups 16. Femoral vein cannot accommodate a 29 F catheter 17. Contraindication to Transoesophageal echocardiography (TEE) 18. Life expectancy \<1 year due to non-cardiac comorbidities. 19. Presence of other anatomic, comorbid conditions, or other medical conditions that could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results, in the opinion of the Heart Team 20. Participation in other clinical investigation 21. Pregnant or planning to become pregnant