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

Inclusion Criteria:

• Patients must meet ALL the following inclusion criteria :

1. with primary or secondary mitral regurgitation recorded by TTE and confirmed duringTEE where surgery for mitral valve repair is required with indications consistent withAHA/ACC and ESC/EACTS guidelines :
2. primary (degenerative) : severe MR grade parameters (R Vol and EROA measured byPISA 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 fromthe primary MR and are based on the prognostic value of these thresholds topredict the poor outcome, or for patients undergoing CABG
3. with LVEF ≥ 30%
4. in satisfactory condition, based on the physical examination and investigator'sexperience, with a life expectancy above one year after the intervention
5. with or without concomitant procedures as: CABG, other valve repair/replacement,pacemaker implantation, exclusion of left appendage (with device or surgically) andMaze (or PVI) procedure
6. willing to sign the informed consent;
7. able and willing to comply with all clinical investigation requirements, including therequired 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
3. LVEDD < 45 mm
4. C-Sd < 25mm (distance from the septum to the mitral valve coaptation point)
5. Basal-IVDd > 15 mm
6. aorto-mitral angle < 120°
7. pre-repair posterior leaflet height > 15 mm
8. with cardiogenic shock;
9. with active endocarditis (or having had active endocarditis in the last threemonths);
10. with active myocarditis;
11. with heavily calcified mitral annulus;
12. with mitral stenosis;
13. unable to take anticoagulation medications;
14. with a known untreatable allergy to contrast media or nickel;
15. with a major or progressive non-cardiac disease that, in the investigator'sexperience, results in a life expectancy shorter than 1 year, or for whom theimplant of the device produces an unacceptable increase of risk;
16. with contraindication to transoesophageal echocardiography;
17. with contraindication to cardiopulmonary bypass;
18. who are pregnant or breast-feeding women;
19. involved in any other clinical investigation for drugs or devices;
20. unable to understand and sign the ICF in absence of legal protection;
21. unable to read and write;