[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580144":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":19,"interventions":28,"overallOfficials":13,"centralContacts":34,"locations":40,"responsibleParty":56,"collaborators":13,"id":58,"slug":13,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":13,"enrollmentInfo":67,"targetDuration":13,"studyType":70,"phases":13,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":42,"whyStopped":13,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Edwards Lifesciences","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Composite (All-Cause Death or Heart Failure Hospitalization)","Time to death or heart failure hospitalization after time zero","2 years",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","RETROSPECTIVE","This is a retrospective, non-randomized cohort study measuring 2-year effectiveness of the EVOQUE Transcatheter Tricuspid Valve Replacement (TTVR) system in the real-world.\n\nThis study will retrospectively evaluate EVOQUE treated patients in the STS\u002FACC TVT Registry who have at least severe Tricuspid Regurgitation and can be deterministically linked with Medicare data.\n\nThis group will be compared to Medicare eligible and EVOQUE eligible patients evaluated in a standard of care setting from a commercial claims database linked with electronic health records.\n\nWe will evaluate the primary outcome measure in various subgroups.\n\nThere will be continued access enrollment after the primary completion date.","Medicare eligible real-world patients with severe, symptomatic tricuspid regurgitation",[20,25],{"label":21,"type":13,"description":22,"interventionNames":23},"EVOQUE treated","Medicare patients with at least severe Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Replacement with the EVOQUE device and is identified in the TVT Registry",[24],"Other: EVOQUE",{"label":26,"type":13,"description":27,"interventionNames":13},"EVOQUE eligible","Medicare eligible patients with severe, symptomatic Tricuspid Regurgitation that are identifiable in a commercial claims database linked with electronic health records.",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":13},"OTHER","EVOQUE","This is a retrospective, non-randomized study. The decision to intervene by TTVR with the EVOQUE device is made by the heart team.",[21],[35],{"name":36,"role":37,"phone":38,"phoneExt":13,"email":39},"TMTT GHER","CONTACT","949-250-3849","TMTT_GHER_EVIDENCE@edwards.com",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Irvine","California","92614","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-117.82311,33.66946,{"lat":52,"lon":51},[55],{"name":36,"role":37,"phone":13,"phoneExt":13,"email":39},{"type":57,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100580144",false,"NCT06833476","TTVR STRONG Under Coverage With Evidence Development (CED) Study","Transcatheter Tricuspid Valve Replacement (TTVR) in Patients With Severe TR ONgoing Evidence Generation (STRONG) Under Coverage With Evidence Development (CED)","STRONG","Inclusion Criteria:\n\nMedicare eligible patients who have received an EVOQUE device or are EVOQUE eligible and have at least severe Tricuspid Regurgitation\n\nExclusion Criteria:\n\nCommercially insured patients who have received an EVOQUE device or are EVOQUE eligible or Medicare eligible patients with less than severe Tricuspid Regurgitation","ALL","65 Years",{"count":68,"type":69},2044,"ESTIMATED","OBSERVATIONAL","This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Replacement procedure using the EVOQUE system.",[73],"Tricuspid Regurgitation",[31,75,76,77],"Coverage with Evidence Development","CED","TVT Registry","2025-03-27",{"date":80,"type":81},"2025-03-28","ACTUAL",{"date":83,"type":81},"2025-03-19",{"date":85,"type":69},"2032-12-31",{"name":5,"class":6},1]