[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659061":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":19,"interventions":30,"overallOfficials":13,"centralContacts":37,"locations":43,"responsibleParty":59,"collaborators":13,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":13,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":13,"enrollmentInfo":70,"targetDuration":13,"studyType":73,"phases":13,"briefSummary":74,"conditions":75,"keywords":81,"overallStatus":85,"whyStopped":13,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"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 prospectively designed, retrospective non-randomized cohort study to measure the 2-year effectiveness of the PASCAL Precision Transcatheter Valve Repair system (\"PASCAL Precision system\") for the treatment of at least severe tricuspid regurgitation in the real world.\n\nThis study will evaluate patients treated with the PASCAL Precision system who have at least severe Tricuspid Regurgitation as compared to Medicare eligible untreated patients. Analysis will be completed using a large, de-identified, claims and electronic health record (EHR) database and supplemented with registry and other claims data.\n\nThe primary outcome will also be assessed in various pre-defined subgroups.","Medicare eligible real-world patients with severe tricuspid regurgitation",[20,25],{"label":21,"type":13,"description":22,"interventionNames":23},"PASCAL Precision system Treated","Patients 65 years old or older with at least severe Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair with the PASCAL Precision system.",[24],"Device: PASCAL Precision system Treated",{"label":26,"type":13,"description":27,"interventionNames":28},"Medicare Eligible Untreated Patients","Patients 65 years old or older with at least severe Tricuspid Regurgitation who did not receive any transcatheter or surgical tricuspid valve intervention.",[29],"Other: Medicare Eligible Untreated Patients",[31,34],{"type":32,"name":21,"description":22,"armGroupLabels":33,"otherNames":13},"DEVICE",[21],{"type":35,"name":26,"description":27,"armGroupLabels":36,"otherNames":13},"OTHER",[26],[38],{"name":39,"role":40,"phone":41,"phoneExt":13,"email":42},"TMTT GHER","CONTACT","949-250-2500","TMTT_GHER_Evidence@edwards.com",[44],{"facility":5,"status":13,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Irvine","California","92614","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-117.82311,33.66946,{"lat":54,"lon":53},[57],{"name":39,"role":40,"phone":41,"phoneExt":13,"email":58},"TMTT_GHER_EVIDENCE@edwards.com",{"type":60,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100659061","the-clasp-iii-tr-ced-study-100659061",false,"NCT07859709","The CLASP III TR CED Study","Edwards PASCAL Transcatheter Tricuspid Valve Repair System Coverage With Evidence Development Study (The CLASP III TR CED Study)","Inclusion Criteria:\n\n* Medicare eligible patients, 65 years old or older\n* With at least severe Tricuspid Regurgitation who have either received PASCAL Precision system or been managed medically with no transcatheter or surgical tricuspid valve intervention\n\nExclusion Criteria:\n\n* Patients not eligible for Medicare (i.e., under 65 years old)\n* Patients with less than severe Tricuspid Regurgitation\n* Patients who have received a transcatheter or surgical intervention other than PASCAL Precision system","ALL","65 Years",{"count":71,"type":72},2350,"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 Repair procedure using the PASCAL Precision system.",[76,77,78,79,80],"Tricuspid Regurgitation","Heart Valve Diseases","Heart Diseases","Cardiovascular Diseases","Tricuspid Valve Insufficiency",[82,83,84],"PASCAL","Coverage with Evidence Development","CED","NOT_YET_RECRUITING","2026-10-01",{"date":88,"type":89},"2026-10-06","ACTUAL",{"date":91,"type":72},"2026-10-15",{"date":93,"type":72},"2033-10-31",{"name":5,"class":6},1]