Registry for MitraClip treatment of severe mitral valve regurgitation
The GIOTTO4 Study: GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4
This study is testing how well the MitraClip G4 device works and is safe for people with severe mitral valve leakage who are getting a specific type of heart repair.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 264 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione GISE Onlus Academic / other |
| Locations | 1 site (San Donato Milanese, Milano) |
| Trial ID | NCT05455489 on ClinicalTrials.gov |
What this trial studies
The GISE Registry aims to confirm the safety and effectiveness of the MitraClip G4 device in patients with symptomatic severe mitral regurgitation undergoing Transcatheter Edge-to-Edge Repair (TEER). This observational study will include a diverse population of patients, both with functional and degenerative mitral regurgitation, who meet specific clinical criteria. The study will collect data on patient outcomes to enhance understanding of the device's performance in real-world settings.
Who should consider this trial
Good fit: Ideal candidates include adults with symptomatic severe mitral regurgitation who are on optimal medical therapy and meet specific echocardiographic and clinical criteria.
Not a fit: Patients with mild or moderate mitral regurgitation or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with severe mitral valve regurgitation.
How similar studies have performed: Other studies have shown success with similar transcatheter approaches for mitral valve repair, indicating a promising avenue for treatment.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
San Donato Milanese, Milano
- I.R.C.C.S. Policlinico San Donato — San Donato Milanese, Milano, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.