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

Inclusion criteria

Patients

• with symptomatic severe Mitral Regurgitation (Carpentier's classification Type I or II P2) or in asymptomatic subjects with preserved Left Ventricle function and new onset of atrial fibrillation or pulmonary hypertension;
• with EuroScore II < 4;
• with Left Ventricle Ejection Fraction ≥ 55%;
• with normal coronary angiogram (no significant lesions);
• in satisfactory condition, based on the physical exam and investigator's experience, with a life expectancy above one year after the intervention;
• willing to sign the informed consent;
• willing to undergo all medical follow-up, echocardiography examinations and laboratory tests planned for the clinical investigation.

Exclusion criteria

Patients

• of age < 18 years;
• who are pregnant;
• nursing mothers;
• who require undergoing MRI examination;
• involved in any other clinical investigation for drugs or devices;
• with previous cardiac surgery or diaphragmatic lesion or previous hepatic surgery;
• needing acute intervention;
• with active endocarditis (or having had active endocarditis in the last three months);
• with active myocarditis;
• with heavily calcified mitral annulus or mitral valve anatomy with a high risk of valve replacement instead of valve repair;
• needing any cardiac surgery other than mitral repair, tricuspid valve annuloplasty, pacemaker implantation (epicardial), exclusion of left appendage (with device or surgically) and Maze (or PVI) procedure;
• with severe pulmonary hypertension (systolic pulmonary artery pressure at rest >65 mmHg);
• with LV Ejection Fraction < 55%;
• with creatinine level > 2.0 mg/100ml;
• with echocardiographic measurements predicting SAM (see specific echocardiography protocol);
• unable to take anticoagulation medications;
• with a known untreatable allergy to contrast media or nickel;
• 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;
• having had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized ≥ 30 days prior to the planned surgical procedure.
• unable to understand and sign the ICF in absence of legal protection
• unable to read and write
• anticipated ring size very small (26mm) or very large (36mm)