Registry for MitraClip treatment of severe mitral valve regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• I.R.C.C.S. Policlinico San Donato
  San Donato Milanese, Milano, Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.