[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617690":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":45,"studyPopulation":11,"armGroups":46,"interventions":63,"overallOfficials":72,"centralContacts":89,"locations":11,"responsibleParty":95,"collaborators":11,"id":97,"slug":11,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":11,"enrollmentInfo":106,"targetDuration":11,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":125,"whyStopped":11,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":11},{"fullName":5,"class":6},"Medtronic Cardiovascular","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Rate of Major Adverse Events (MAE)",null,"30-days post-procedure",{"measure":14,"description":11,"timeFrame":15},"Composite Endpoint: All-cause mortality, Heart failure hospitalization, and tricuspid valve reintervention","1-year post-procedure",[17,21,24,27,29,32,35],{"measure":18,"description":19,"timeFrame":20},"Tricuspid regurgitation (TR) grade reduction","Total number of patients with at least one grade TR reduction","6 months post-procedure",{"measure":22,"description":23,"timeFrame":20},"Change in quality of life (QoL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline","KCCQ overall summary score is a patient-reported measure of health status. Scores range from 0 to 100 where higher scores reflect better quality of life",{"measure":25,"description":11,"timeFrame":26},"All-cause mortality","12 months post-procedure",{"measure":28,"description":11,"timeFrame":26},"Heart failure hospitalization",{"measure":30,"description":11,"timeFrame":31},"New onset conduction disturbance (NOCD)","30 days post-procedure",{"measure":33,"description":11,"timeFrame":34},"Total procedure time","Procedure",{"measure":36,"description":11,"timeFrame":26},"Right ventricle (RV) dysfunction",{"allocation":38,"interventionModel":39,"interventionModelDescription":11,"primaryPurpose":40,"observationalModel":11,"timePerspective":11,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":11,"whoMasked":43},"SINGLE",[44],"OUTCOMES_ASSESSOR","Prospective, global, pre-market, interventional, multi-center, randomized controlled pivotal trial to evaluate the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System compared to Edwards EVOQUE TTVR System in symptomatic patients with severe or greater tricuspid regurgitation.",[47,53,59],{"label":48,"type":49,"description":50,"interventionNames":51},"Medtronic Intrepid™ TTVR","EXPERIMENTAL","Transcatheter tricuspid valve replacement with Medtronic Intrepid™ TTVR System in patients with severe or greater tricuspid regurgitation.",[52],"Device: Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System",{"label":54,"type":55,"description":56,"interventionNames":57},"Edwards EVOQUE TTVR","ACTIVE_COMPARATOR","Transcatheter tricuspid valve replacement with Edwards EVOQUE TTVR in patients with severe or greater tricuspid regurgitation.",[58],"Device: Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System",{"label":60,"type":49,"description":61,"interventionNames":62},"Single Arm Registry","Transcatheter tricuspid valve replacement with Medtronic Intrepid™ TTVR System in patients with severe or greater tricuspid regurgitation who are not eligible for randomization.",[52],[64,69],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":11},"DEVICE","Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System","Transcatheter Tricuspid Valve Replacement",[48,60],{"type":65,"name":70,"description":67,"armGroupLabels":71,"otherNames":11},"Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System",[54],[73,77,80,83,86],{"name":74,"affiliation":75,"role":76},"Vinayak N. Bapat, MD","Minneapolis Heart Institute","PRINCIPAL_INVESTIGATOR",{"name":78,"affiliation":79,"role":76},"Anita Asgar, MD","Northwestern Medicine Bluhm Cardiovascular Institute",{"name":81,"affiliation":82,"role":76},"Nicolas Dumonteil, MD","Clinique Pasteur Groupe CardioVasculaire Interventionnel",{"name":84,"affiliation":85,"role":76},"Azeem Latib, MD","Montefiore Medical Center",{"name":87,"affiliation":88,"role":76},"Firas Zahr, MD","Knight Cardiovascular Institute",[90],{"name":91,"role":92,"phone":93,"phoneExt":11,"email":94},"Amber St Martin","CONTACT","612-380-5637","rs.pathfinder@medtronic.com",{"type":96,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100617690",false,"NCT07321899","Transcatheter Tricuspid Valve Replacement With the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation","Transcatheter Tricuspid Valve Replacement Using the Medtronic Intrepid™ TTVR System in Patients With Severe Symptomatic Tricuspid Regurgitation - PATHFINDER","PATHFINDER","Inclusion Criteria:\n\n* Age ≥18 years at the time of consent.\n* Severe symptomatic tricuspid regurgitation (TR) despite optimal medical therapy (OMT).\n* Local site multidisciplinary heart team experienced in tricuspid valve therapies agrees that the subject is appropriate for TTVR.\n\nExclusion Criteria:\n\n* Any tricuspid device currently in place.\n* Anatomic contraindications.\n* Need for emergent or urgent surgery.\n* Left ventricular ejection fraction \\\u003C25%.","ALL","18 Years",{"count":107,"type":108},1186,"ESTIMATED","INTERVENTIONAL",[111],"NA","This clinical trial evaluates the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in symptomatic patients with severe or greater tricuspid regurgitation.",[114],"Severe Tricuspid Regurgitation",[116,117,118,119,120,121,122,123,124],"Tricuspid Regurgitation","Symptomatic tricuspid regurgitation","Heart valve disease","Structural heart intervention","Severe valve disease","Randomized controlled trial","tricuspid insufficiency","tricuspid disease","tricuspid valve disease","NOT_YET_RECRUITING","2026-01-06",{"date":128,"type":129},"2026-01-08","ACTUAL",{"date":131,"type":108},"2026-06",{"date":133,"type":108},"2041-04",{"name":5,"class":6}]