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

Overview

The aim of the GISE study is to confirm the MitraClip safety and improve the device effectiveness in a selected all comers ("more-comers") population with symptomatic severe mitral regurgitation undergoing/undergone Transcatheter Edge-to-Edge Repair (TEER) with MitraClip G4.

Eligibility

Inclusion Criteria:

        SUBGROUP A: FUNCTIONAL MR Patients with symptomatic severe secondary MR (3-4+, according to
        the multiparametric study algorithm), both ischemic or non-ischemic etiology, on optimal
        medical 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 natriuretic
             peptide 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 coronary
             artery disease, LV (left ventricular) dysfunction, MR Mitral (regurgitation) and HF
          -  Local Heart-team decision SUBGROUP B: DEGENERATIVE MR Patients with symptomatic severe
             primary 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 XT
             device
          -  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 will
             be assigned to a subgroup based on the prevailing mechanism.
        THE MULTIPARAMETRIC ALGORITHM FOR MR GRADING The multiparametric algorithm, adapted from
        the criteria recommended by the American Society of Echocardiography 2003 Guidelines and
        based on 3 tiers of evaluation, will be used for qualification purposes to determine if MR
        was 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 the
        integrative evaluation of multiple parameters recommended by the The American Society of
        Echocardiography (ASE)
        Exclusion Criteria:
          -  Significant right ventricular disfunction (TAPSE<15 mm and/or S'<8cm/s)
          -  Systolic pulmonary artery > 70 mmHg with irreversible precapillary pulmonary
             hypertension
          -  Severe TR Tricuspid valve regurgitation
          -  Hemodynamic instability/NYHA IV
          -  Impaired mobility as a result of neurological or musculoskeletal disease, or advanced
             dementia
          -  Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip
             positioning 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, TAVR
             transcatheter 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)