[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100285508":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":104,"collaborators":107,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":112,"sex":118,"minAge":119,"maxAge":25,"enrollmentInfo":120,"targetDuration":25,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":130,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Ospedale San Raffaele","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"M & T Repair Group","EXPERIMENTAL","Both mitral and tricuspid valves repair",[13],"Procedure: M & T Repair Group",{"label":15,"type":16,"description":17,"interventionNames":18},"Mitral-Only Group","ACTIVE_COMPARATOR","Only mitral valve repair",[19],"Procedure: Mitral-Only Group",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","After the mitral valve repair a device for tricuspid annuloplasty will be implanted.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Mitral valve repair alone; after the mitral valve repair no device for tricuspid annuloplasty will be implanted.",[15],[30],{"name":31,"affiliation":32,"role":33},"Michele De Bonis, MD,FESC,FAHA","IRCCS Ospedale San Raffale Milano","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","00390226437118","debonis.michele@hsr.it",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Cinzia Trumello, MD","00390226437127","trumello.cinzia@hsr.it",[44,67,87],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Istituto Clinico Humanitas","RECRUITING","Rozzano","Milano","20089","Italy","IT",{"type":53,"coordinates":54},"Point",[55,56],9.1559,45.38193,{"lat":56,"lon":55},[59,63,64],{"name":60,"role":36,"phone":61,"phoneExt":25,"email":62},"Lucia Torracca, MD","00390282244330","lucia.torracca@humanitas.it",{"name":60,"role":33,"phone":25,"phoneExt":25,"email":25},{"name":65,"role":66,"phone":25,"phoneExt":25,"email":25},"Andrea Fumero, MD","SUB_INVESTIGATOR",{"facility":68,"status":46,"city":69,"state":25,"zip":70,"country":50,"countryCode":51,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"IRCCS Ospedale San Raffaele","Milan","20132",{"type":53,"coordinates":72},[73,74],9.18951,45.46427,{"lat":74,"lon":73},[77,79,80,81,83,85],{"name":78,"role":36,"phone":37,"phoneExt":25,"email":38},"Michele De Bonis, MD",{"name":31,"role":33,"phone":25,"phoneExt":25,"email":25},{"name":40,"role":66,"phone":25,"phoneExt":25,"email":25},{"name":82,"role":66,"phone":25,"phoneExt":25,"email":25},"Teodora Nisi, MD",{"name":84,"role":66,"phone":25,"phoneExt":25,"email":25},"Elisabetta Lapenna, MD",{"name":86,"role":66,"phone":25,"phoneExt":25,"email":25},"Ottavio Alfieri, MD",{"facility":88,"status":46,"city":89,"state":25,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland","Warsaw","02-507","Poland","PL",{"type":53,"coordinates":94},[95,96],21.01178,52.22977,{"lat":96,"lon":95},[99,103],{"name":100,"role":36,"phone":101,"phoneExt":25,"email":102},"Piotr Suwalski, MD","0048225081260","suwalski.piotr@gmail.com",{"name":100,"role":33,"phone":25,"phoneExt":25,"email":25},{"type":33,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Michele De Bonis","Associate Professor",[108,109],{"name":45,"class":6},{"name":88,"class":6},"100285508","annuloplasty-for-not-severe-tr-in-patients-undergoing-mv-repair-versus-mitral-repair-only-nostrum-100285508",false,"NCT02996552","Annuloplasty for Not-Severe TR in Patients Undergoing MV Repair Versus Mitral Repair Only (NOSTRUM)","Annuloplasty for the Treatment of Not-Severe Tricuspid Regurgitation in Patients Undergoing Surgery for Mitral Valve Disease: a Prospective, Spontaneous, Multicentre, Randomized Study","NOSTRUM","Inclusion Criteria:\n\n* age \\> 18 years;\n* ability to provide informed consent;\n* patients scheduled for mitral valve regurgitation\n* TR ≤ 2+ with annular dilation\n* Tricuspid diastolic diameter ≥ 40 mm or 21 mm\u002Fm2\n\nExclusion Criteria:\n\n* patient's refusal\n* non-elective cardiac surgery;\n* organic disease of tricuspid valve\n* TR≥3","ALL","18 Years",{"count":121,"type":122},142,"ESTIMATED","INTERVENTIONAL",[125],"NA","The surgical treatment of less than severe (≤2+\u002F4+) functional tricuspid regurgitation (TR) in patient undergoing mitral valve surgery, is still controversial: some observational studies have suggested that performing tricuspid annuloplasty in patients undergoing mitral valve surgery with a dilated tricuspid annulus, and TR≤2+ may provide a clinical benefit, while in other observational studies such benefit has not been documented.\n\nThe ESC Guidelines assign the class IIa recommendation for surgical treatment in patients with tricuspid regurgitation ≤2+ and a dilated annulus, if surgery is concomitant to the repair or replacement of the mitral valve. However the level of evidence C (expert opinion) confirms the absence of clear scientific evidence to support this recommendation.\n\nIt is therefore very important to carry out randomized trials designed to really prove the supposed efficacy of prophylactic tricuspid annuloplasty, especially in patients with degenerative etiology where the data are particularly controversial.\n\nThe aim of the study will be to establish the effectiveness of the tricuspid annuloplasty in the early stage of TR. The investigators enrolled patients with TR≤2+ and annular dilation undergoing mitral valve repair.\n\nPrimary end-point will be the freedom from recurrence of TR≥3+ and from progression of 2 degrees of TR compared to pre-operative, at discharge and 12 months after surgery, assessment by transthoracic echocardiography. Secondary endpoints are to demonstrate the superiority of combined treatment (M \\& T Repair Group) compared to single treatment (Mitral-Only Group) at 5 and 10 years after surgery.\n\nThis will be an experimental superiority, prospective, spontaneous, multicenter, randomized trial.\n\nPatients will be randomly assigned to two parallel arms with an allocation ratio 1:1 stratified by center, to receive mitral repair only (Mitral-Only group) or both mitral and tricuspid repair (M \\& T Repair group).",[128,129],"Tricuspid Disease","Mitral Regurgitation",[131,132],"Tricuspid annulus dilation","mitral valve regurgitation","2020-07-20",{"date":135,"type":136},"2020-07-21","ACTUAL",{"date":138,"type":136},"2011-06-08",{"date":140,"type":122},"2030-12",{"name":5,"class":6},3]