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.
Left Ventricular End-Systolic Dimension <70 mm
Mitral Valve area > 4 cmq
Left ventricular ejection fraction ≥20%
NYHA functional class II, III, ambulatory IV
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
Patients undergoing/undergone to TEER procedure with MitraClip G4 in selected hospitals linked to the GISE network. Patients should meet all the inclusion criteria and none of the exclusion criteria; such criteria will identify a selected all comers ("more-comers") population which includes the vast majority of patients treated with MitraClip in daily practice. Retrospective enrolments are allowed if available data are in line with the study requirements and the patients can give their consent to be enrolled in the study informed consent process. Patients who don't meet one or more of the inclusion criteria or met at least one exclusion criteria are excluded from the study; however, a selected list of baseline/procedural features and follow-up data will be recorded for excluded patients.
Cohort
Prospective
Not listed
percentage of participants with a mitral regurgitation (MR)
grade ≤1+. Two separates subgroups will be identified according to the presence of functional (FMR) or degenerative (DMR) mitral valve disease.
percentage of participants with a mitral regurgitation (MR)
grade ≤1+. Two separates subgroups will be identified according to the presence of functional (FMR) or degenerative (DMR) mitral valve disease.
composite of all-cause death and hospitalization for heart failure (HF),
all-cause death, cardiovascular death and non-cardiovascular death, myocardial infarction, hospitalizations for HF,
composite of all-cause death and hospitalization for heart failure (HF),
all-cause death, cardiovascular death and non-cardiovascular death, myocardial infarction, hospitalizations for HF,
composite of all-cause death and hospitalization for heart failure (HF),
all-cause death, cardiovascular death and non-cardiovascular death, myocardial infarction, hospitalizations for HF,
composite of all-cause death and hospitalization for heart failure (HF),
all-cause death, cardiovascular death and non-cardiovascular death, myocardial infarction, hospitalizations for HF,
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