GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4

Inclusion Criteria: SUBGROUP A: FUNCTIONAL MR Patients with symptomatic severe secondary MR (3-4+, according tothe multiparametric study algorithm), both ischemic or non-ischemic etiology, on optimalmedical therapy AND

• Left Ventricular End-Systolic Dimension <70 mm
• Mitral Valve area > 4 cmq
• Left ventricular ejection fraction ≥20%
• NYHA functional class II, III, ambulatory IV
• brain natriuretic peptide BNP ≥300 pg/ml or N-terminal prohormone of brain natriureticpeptide NT-proBNP ≥1500 pg/ml and/or at least one hosp for HF (Heart failure) in the 12 months prior to enrollment
• Age 18 years or older
• Subject has been adequately treated per applicable standards, including for coronaryartery disease, LV (left ventricular) dysfunction, MR Mitral (regurgitation) and HF
• Local Heart-team decision SUBGROUP B: DEGENERATIVE MR Patients with symptomatic severeprimary MR (3-4+, according to the multiparametric study algorithm) AND
• Mobile mitral valve (MV) length of PL ≥8 mm in case of NT device, ≥10 mm in case of XTdevice
• MV area > 4 cm2
• NYHA functional class > II
• Age 18 years or older
• Local HT decision In case of patients with a coexistence of both etiologies, they willbe assigned to a subgroup based on the prevailing mechanism. THE MULTIPARAMETRIC ALGORITHM FOR MR GRADING The multiparametric algorithm, adapted fromthe criteria recommended by the American Society of Echocardiography 2003 Guidelines andbased on 3 tiers of evaluation, will be used for qualification purposes to determine if MRwas 3+ or higher. The 3 tiers of evaluation are applied in a hierarchical manner (from tier 1 to 3) and patients qualified for TEER by meeting the criteria of at least one of them.For MR grading purposes, MR severity was subsequently graded as 3+ or 4+ based on theintegrative evaluation of multiple parameters recommended by the The American Society ofEchocardiography (ASE)

Exclusion Criteria:

• Significant right ventricular disfunction (TAPSE<15 mm and/or S'<8cm/s)
• Systolic pulmonary artery > 70 mmHg with irreversible precapillary pulmonaryhypertension
• Severe TR Tricuspid valve regurgitation
• Hemodynamic instability/NYHA IV
• Impaired mobility as a result of neurological or musculoskeletal disease, or advanceddementia
• Leaflet anatomy which may preclude MitraClip implantation, proper MitraClippositioning on the leaflets or sufficient reduction in MR by the MitraClip
• Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis,infiltrative cardiomyopathies
• CABG coronary artery bypass graft, PCI percutaneous coronary intervention, TAVRtranscatheter aortic valve replacement, CVA cardiovascular accident within the prior 60 days
• Life expectancy <12 months due to non-cardiac conditions
• Active infections
• Advanced HF (ESC/HFA Heart Failure Association Criteria) or Bridge tp to HTx/LVAD (left ventricular assist device)