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

Launched by FONDAZIONE GISE ONLUS · Jul 8, 2022

Keywords

ClinConnect Summary

The GISE Registry study is investigating the safety and effectiveness of a device called the MitraClip G4 for treating a heart condition known as mitral valve regurgitation, where the heart's mitral valve doesn't close properly, causing blood to flow backward. This study is open to adults aged 18 and older who have severe symptoms from this condition. Two main groups of patients are being considered: those with secondary mitral regurgitation due to heart failure and those with primary mitral regurgitation due to problems with the valve itself. Participants will be closely evaluated to ensure they meet specific health criteria, including heart function and the severity of their condition.

If you decide to participate in this trial, you'll receive the MitraClip treatment, which is done through a minimally invasive procedure, meaning it doesn't require open-heart surgery. The goal is to help improve your heart function and relieve symptoms. Before joining, you'll need to go through a thorough assessment to confirm your eligibility. Throughout the study, your health will be monitored, helping researchers gather valuable information about the MitraClip's performance in a diverse group of patients.

Gender

ALL

Eligibility criteria

• 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)