[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633564":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":35,"centralContacts":43,"locations":29,"responsibleParty":49,"collaborators":29,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":29,"enrollmentInfo":61,"targetDuration":29,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":29,"overallStatus":70,"whyStopped":29,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":29},{"fullName":5,"class":6},"TRiCares","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"TRiCares Topaz TTVR","EXPERIMENTAL","Transcatheter tricuspid valve replacement with TRiCares Topaz TTVR",[13],"Device: TRiCares Topaz TTVR System",{"label":15,"type":16,"description":17,"interventionNames":18},"Edwards EVOQUE TTVR","ACTIVE_COMPARATOR","Transcatheter tricuspid valve replacement with Edwards EVOQUE TTVR",[19],"Device: Edwards EVOQUE TTVR System",{"label":21,"type":10,"description":22,"interventionNames":23},"Single Arm Registry","Patients eligible to receive the TRiCares Topaz TTVR system, but not eligible for the Edwards EVOQUE system will be enrolled in the non-randomized, single-arm registry and treated with Topaz TTVR.",[13],[25,30,33],{"type":26,"name":27,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","TRiCares Topaz TTVR System",[9],null,{"type":26,"name":31,"description":31,"armGroupLabels":32,"otherNames":29},"Edwards EVOQUE TTVR System",[15],{"type":26,"name":27,"description":27,"armGroupLabels":34,"otherNames":29},[21],[36,40],{"name":37,"affiliation":38,"role":39},"Pradeep Yadav, MD","Piedmont Hospital","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":42,"role":39},"Neil Fam, MD","Unity Health Toronto",[44],{"name":45,"role":46,"phone":47,"phoneExt":29,"email":48},"Stephanie Cihlar","CONTACT","763-227-7833","cihlar@tricares.de",{"type":50,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100633564","the-tricure-us-ide-pivotal-study-100633564",false,"NCT07528326","The TRICURE US IDE Pivotal Study","TRiCares Topaz Transcatheter Tricuspid Heart Valve Replacement System IDE Pivotal Study","TRICURE US IDE","Inclusion Criteria:\n\n* Patient is ≥ 18 years of age\n* Patient has severe or greater tricuspid regurgitation with symptoms despite optimal medical therapy\n* Patient is an appropriate candidate to undergo TTVR as determined by the Institution Heart Team\n\nExclusion Criteria:\n\n* Patient has a tricuspid device currently in place\n* Patient has anatomical contraindications\n* Patient is in need of urgent surgery\n* Patient has a left ventricular ejection fraction of \\\u003C 25%\n* Patient has life expectancy of \\\u003C 1 year","ALL","18 Years",{"count":62,"type":63},831,"ESTIMATED","INTERVENTIONAL",[66],"NA","The purpose of the study is to evaluate safety and effectiveness of the TRiCares Topaz TTVR system for treatment of subjects presenting with clinically relevant tricuspid regurgitation who are suitable for valve replacement.",[69],"Tricuspid Regurgitation (TR)","NOT_YET_RECRUITING","2026-04-29",{"date":73,"type":74},"2026-05-05","ACTUAL",{"date":76,"type":63},"2026-10",{"date":78,"type":63},"2035-09",{"name":5,"class":6}]