[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474252":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":10,"locations":15,"responsibleParty":41,"collaborators":43,"id":49,"slug":10,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":10,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":10,"enrollmentInfo":57,"targetDuration":60,"studyType":61,"phases":10,"briefSummary":62,"conditions":63,"keywords":10,"overallStatus":18,"whyStopped":10,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Fondazione GISE Onlus","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"FUNCTIONAL MR",null,"Patients with symptomatic severe secondary MR (3-4+, according to the multiparametric study algorithm), both ischemic or non-ischemic etiology, on optimal medical therapy",{"label":13,"type":10,"description":14,"interventionNames":10},"DEGENERATIVE MR","Patients with symptomatic severe primary MR (3-4+, according to the multiparametric study algorithm)",[16],{"facility":17,"status":18,"city":19,"state":20,"zip":21,"country":22,"cosmosGeoPoint":23,"geoPoint":28,"contacts":29},"I.R.C.C.S. Policlinico San Donato","RECRUITING","San Donato Milanese","Milano","20097","Italy",{"type":24,"coordinates":25},"Point",[26,27],9.26838,45.41047,{"lat":27,"lon":26},[30,35,38],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Federica Rossi","CONTACT","+390252774987","Federica.Rossi@grupposandonato.it",{"name":36,"role":37,"phone":10,"phoneExt":10,"email":10},"Antonio Popolo Rubbio, MD","PRINCIPAL_INVESTIGATOR",{"name":39,"role":40,"phone":10,"phoneExt":10,"email":10},"Francesco Bedogni, MD","SUB_INVESTIGATOR",{"type":42,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[44,46],{"name":45,"class":6},"University of Padova",{"name":47,"class":48},"Abbott","INDUSTRY","100474252",false,"NCT05455489","GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4","The GIOTTO4 Study: GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4","Inclusion Criteria:\n\nSUBGROUP 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\n\n* Left Ventricular End-Systolic Dimension \\\u003C70 mm\n* Mitral Valve area \\> 4 cmq\n* Left ventricular ejection fraction ≥20%\n* NYHA functional class II, III, ambulatory IV\n* brain natriuretic peptide BNP ≥300 pg\u002Fml or N-terminal prohormone of brain natriuretic peptide NT-proBNP ≥1500 pg\u002Fml and\u002For at least one hosp for HF (Heart failure) in the 12 months prior to enrollment\n* Age 18 years or older\n* Subject has been adequately treated per applicable standards, including for coronary artery disease, LV (left ventricular) dysfunction, MR Mitral (regurgitation) and HF\n* Local Heart-team decision SUBGROUP B: DEGENERATIVE MR Patients with symptomatic severe primary MR (3-4+, according to the multiparametric study algorithm) AND\n* Mobile mitral valve (MV) length of PL ≥8 mm in case of NT device, ≥10 mm in case of XT device\n* MV area \\> 4 cm2\n* NYHA functional class \\> II\n* Age 18 years or older\n* 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.\n\nTHE 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)\n\nExclusion Criteria:\n\n* Significant right ventricular disfunction (TAPSE\\\u003C15 mm and\u002For S'\\\u003C8cm\u002Fs)\n* Systolic pulmonary artery \\> 70 mmHg with irreversible precapillary pulmonary hypertension\n* Severe TR Tricuspid valve regurgitation\n* Hemodynamic instability\u002FNYHA IV\n* Impaired mobility as a result of neurological or musculoskeletal disease, or advanced dementia\n* Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip\n* Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, infiltrative cardiomyopathies\n* CABG coronary artery bypass graft, PCI percutaneous coronary intervention, TAVR transcatheter aortic valve replacement, CVA cardiovascular accident within the prior 60 days\n* Life expectancy \\\u003C12 months due to non-cardiac conditions\n* Active infections\n* Advanced HF (ESC\u002FHFA Heart Failure Association Criteria) or Bridge tp to HTx\u002FLVAD (left ventricular assist device)","ALL","18 Years",{"count":58,"type":59},264,"ESTIMATED","5 Years","OBSERVATIONAL","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\u002Fundergone Transcatheter Edge-to-Edge Repair (TEER) with MitraClip G4.",[64],"Mitral Valve Regurgitation","2024-03-01",{"date":67,"type":68},"2024-03-04","ACTUAL",{"date":70,"type":68},"2023-01-25",{"date":72,"type":59},"2029-08-01",{"name":5,"class":6},1]