Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05455489 | RECRUITING | Mitral Valve Regurgitation

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

GISE Onlus Foundation

Brief 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.

Condition or disease

Mitral Valve Regurgitation

Study Type : OBSERVATIONAL
Estimated Enrollment : 264 participants
Official Title : The GIOTTO4 Study: GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4
Actual Study Start Date : 2023-01-25
Estimated Primary Completion Date : 2029-08-01
Estimated Study Completion Date : 2029-08-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4

Location Details

NCT05455489

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Italy, Milano

I.R.C.C.S. San Donato Polyclinic

San Donato Milanese, Milano, Italy, 20097