[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560770":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":33,"responsibleParty":133,"collaborators":31,"id":135,"slug":136,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":137,"sex":143,"minAge":144,"maxAge":31,"enrollmentInfo":145,"targetDuration":31,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":31,"overallStatus":36,"whyStopped":31,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"TRiCares","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Transcatheter Tricuspid Valve Replacement","EXPERIMENTAL","Treatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System",[13],"Device: Transcatheter Tricuspid Valve Replacement",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Replacement of the tricuspid valve through a transcatheter approach",[9],[20],"TRiCares Topaz Tricuspid Valve Replacement System",[22],{"name":23,"affiliation":24,"role":25},"Jörg Hausleiter, MD","LMU Munich","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Esther Gerteis","CONTACT","+41796015318",null,"gerteis@tricares.de",[34,53,64,76,84,96,108,122],{"facility":35,"status":36,"city":37,"state":31,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Algemeen Stedelijk Ziekenhuis","RECRUITING","Aalst","9300","Belgium","BE",{"type":42,"coordinates":43},"Point",[44,45],4.0355,50.93604,{"lat":45,"lon":44},[48,52],{"name":49,"role":29,"phone":50,"phoneExt":31,"email":51},"Liesbeth Rosseel, MD","003253766730","liesbeth.rosseel@asz.be",{"name":49,"role":25,"phone":31,"phoneExt":31,"email":31},{"facility":54,"status":36,"city":55,"state":31,"zip":31,"country":39,"countryCode":40,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"ZNA Middelheim","Antwerp",{"type":42,"coordinates":57},[58,59],4.40026,51.22047,{"lat":59,"lon":58},[62],{"name":63,"role":29,"phone":31,"phoneExt":31,"email":31},"Stefan Verheye, MD",{"facility":65,"status":36,"city":66,"state":31,"zip":67,"country":39,"countryCode":40,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"UZ Brussel","Brussels","1090",{"type":42,"coordinates":69},[70,71],4.34878,50.85045,{"lat":71,"lon":70},[74],{"name":75,"role":29,"phone":31,"phoneExt":31,"email":31},"Stijn Lochy, MD",{"facility":77,"status":36,"city":66,"state":31,"zip":31,"country":39,"countryCode":40,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"Cliniques Universitaires Saint-Luc UCL",{"type":42,"coordinates":79},[70,71],{"lat":71,"lon":70},[82],{"name":83,"role":29,"phone":31,"phoneExt":31,"email":31},"Joelle Kefer, MD",{"facility":85,"status":86,"city":87,"state":31,"zip":31,"country":39,"countryCode":40,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Centre hospitalier universitaire CHU de Liège","NOT_YET_RECRUITING","Liège",{"type":42,"coordinates":89},[90,91],5.56749,50.63373,{"lat":91,"lon":90},[94],{"name":95,"role":29,"phone":31,"phoneExt":31,"email":31},"Patrizio Lancellotti, MD",{"facility":97,"status":36,"city":98,"state":31,"zip":99,"country":39,"countryCode":40,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"AZ Delta","Roeselare","8800",{"type":42,"coordinates":101},[102,103],3.12269,50.94653,{"lat":103,"lon":102},[106],{"name":107,"role":29,"phone":31,"phoneExt":31,"email":31},"Maarten Vanhaverbeke, MD",{"facility":109,"status":86,"city":110,"state":31,"zip":111,"country":112,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"University Medical Center of the Johannes Gutenberg University Mainz","Mainz","55131","Germany","DE",{"type":42,"coordinates":115},[116,117],8.28008,49.98185,{"lat":117,"lon":116},[120],{"name":121,"role":29,"phone":31,"phoneExt":31,"email":31},"Phiipp Lurz, MD",{"facility":123,"status":36,"city":124,"state":31,"zip":125,"country":112,"countryCode":113,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Ludwig Maximilian University Hospital","Munich","81377",{"type":42,"coordinates":127},[128,129],11.57549,48.13743,{"lat":129,"lon":128},[132],{"name":23,"role":29,"phone":31,"phoneExt":31,"email":31},{"type":134,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100560770","the-tricure-eu-pivotal-study-100560770",false,"NCT06581471","The TRICURE EU Pivotal Study","The TRICURE EU PIVOTAL TRiCares Topaz Transcatheter TRICUspid Heart Valve REplacement System EUropean PIVOTAL Study","TRICURE EU","Inclusion Criteria:\n\n* Adult patients\n* Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)\n* Institutional Heart Team evaluates patient as being at increased operative risk\n\nExclusion Criteria:\n\n* Patient in need of emergent intervention\n* Patient who is hemodynamically unstable\n* Anatomical contraindications for implantation with study device\n* Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet","ALL","18 Years",{"count":146,"type":147},80,"ESTIMATED","INTERVENTIONAL",[150],"NA","Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System",[153,154,155],"Tricuspid Valve Regurgitation","Heart Valve Disease","Cardiovascular Diseases","2026-04-10",{"date":158,"type":159},"2026-04-15","ACTUAL",{"date":161,"type":159},"2024-08-29",{"date":163,"type":147},"2030-12-30",{"name":5,"class":6},8]