OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety and Effectiveness Evaluation

This is an interventional treatment trial for Mitral Valve Regurgitation focused on measuring Mitral Regurgitation, Mitral valve repair, Mitral annuloplasty, Adjustable annuloplasty Read More

Inclusion Criteria:

- Patients must meet ALL the following inclusion criteria :

1. with primary or secondary mitral regurgitation recorded by TTE and confirmed during TEE where surgery for mitral valve repair is required with indications consistent with AHA/ACC and ESC/EACTS guidelines :

   1. primary (degenerative) : severe MR grade parameters (R Vol and EROA measured by PISA methods):

      • EROA regurgitant >60 ml and
      • Vena contracta width > 7mm and
      • Regurgitant fraction >50%
   2. Secondary (functional) : severe MR (EROA ≥30 mm²; R Vol > 30ml) may differ from the primary MR and are based on the prognostic value of these thresholds to predict the poor outcome, or for patients undergoing CABG
2. with LVEF ≥ 30%
3. in satisfactory condition, based on the physical examination and investigator's experience, with a life expectancy above one year after the intervention
4. with or without concomitant procedures as: CABG, other valve repair/replacement, pacemaker implantation, exclusion of left appendage (with device or surgically) and Maze (or PVI) procedure
5. willing to sign the informed consent;
6. able and willing to comply with all clinical investigation requirements, including the required study follow-up visits

Exclusion Criteria:

• Patients will be excluded if ANY of the following conditions are present:

  1. of age < 21 years;

  2. with echocardiographic measurements predicting SAM

     1. LVEDD < 45 mm
     2. C-Sd < 25mm (distance from the septum to the mitral valve coaptation point)
     3. Basal-IVDd > 15 mm
     4. aorto-mitral angle < 120°
     5. pre-repair posterior leaflet height > 15 mm
  3. with cardiogenic shock;
  4. with active endocarditis (or having had active endocarditis in the last three months);
  5. with active myocarditis;
  6. with heavily calcified mitral annulus;
  7. with mitral stenosis;
  8. unable to take anticoagulation medications;
  9. with a known untreatable allergy to contrast media or nickel;
  10. with a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy shorter than 1 year, or for whom the implant of the device produces an unacceptable increase of risk;
  11. with contraindication to transoesophageal echocardiography;
  12. with contraindication to cardiopulmonary bypass;
  13. who are pregnant or breast-feeding women;
  14. involved in any other clinical investigation for drugs or devices;
  15. unable to understand and sign the ICF in absence of legal protection;
  16. unable to read and write;