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.
Study Type
OBSERVATIONAL
Enrollment
264
I.R.C.C.S. Policlinico San Donato
San Donato Milanese, Milano, Italy
RECRUITINGpercentage 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.
Time frame: at 30 days
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.
Time frame: at 1 year
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,
Time frame: at 30 days
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,
Time frame: at 1 year
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,
Time frame: at 2 years
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,
Time frame: at 3 years
composite of all-cause death and hospitalization for heart failure (HF),
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all-cause death, cardiovascular death and non-cardiovascular death, myocardial infarction, hospitalizations for HF,
Time frame: at 4 years
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,
Time frame: at 5 years