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

Mitral Valve Regurgitation Clinical Trial

Official title:

The GIOTTO4 Study: GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05455489
• Other study ID #: GISE_GIOTTO4
• Status: Recruiting
• Start date: January 25, 2023
• Est. completion date: August 1, 2029

Study information

• Verified date: March 2024
• Source: Fondazione GISE Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: August 1, 2029
• Est. primary completion date: August 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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)

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Locations

Country	Name	City	State
Italy	I.R.C.C.S. Policlinico San Donato	San Donato Milanese	Milano

Sponsors (3)

Lead Sponsor	Collaborator
Fondazione GISE Onlus	Abbott, University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at 30 days
Primary	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.	at 1 year
Secondary	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,	at 30 days
Secondary	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,	at 1 year
Secondary	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,	at 2 years
Secondary	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,	at 3 years
Secondary	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,	at 4 years
Secondary	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,	at 5 years