[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07321899":3,"trial-entities:NCT07321899":182,"trial-summary:NCT07321899":186},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":49,"secondary_outcomes":56,"sex":77,"minimum_age":78,"maximum_age":79,"healthy_volunteers":80,"eligibility_criteria":81,"std_ages":92,"locations":95,"central_contacts":159,"overall_officials":164,"references":180,"see_also_links":181},"NCT07321899","MDT23032TMV006","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","RECRUITING","2041-04","2026-07","2026-07-28","2026-08","Medtronic Cardiovascular","INDUSTRY",true,"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.","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.",[19],"Severe Tricuspid Regurgitation",[21,22,23,24,25,26,27,28,29],"Tricuspid Regurgitation","Symptomatic tricuspid regurgitation","Heart valve disease","Structural heart intervention","Severe valve disease","Randomized controlled trial","tricuspid insufficiency","tricuspid disease","tricuspid valve disease","INTERVENTIONAL","TREATMENT",[33],"NA",{"count":35,"type":36},1186,"ESTIMATED",[38,45],{"type":39,"name":40,"description":41,"armGroupLabels":42},"DEVICE","Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System","Transcatheter Tricuspid Valve Replacement",[43,44],"Medtronic Intrepid™ TTVR","Single Arm Registry",{"type":39,"name":46,"description":41,"armGroupLabels":47},"Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System",[48],"Edwards EVOQUE TTVR",[50,53],{"measure":51,"timeFrame":52},"Rate of Major Adverse Events (MAE)","30-days post-procedure",{"measure":54,"timeFrame":55},"Composite Endpoint: All-cause mortality, Heart failure hospitalization, and tricuspid valve reintervention","1-year post-procedure",[57,61,64,67,69,72,75],{"measure":58,"description":59,"timeFrame":60},"Tricuspid regurgitation (TR) grade reduction","Total number of patients with at least one grade TR reduction","6 months post-procedure",{"measure":62,"description":63,"timeFrame":60},"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":65,"timeFrame":66},"All-cause mortality","12 months post-procedure",{"measure":68,"timeFrame":66},"Heart failure hospitalization",{"measure":70,"timeFrame":71},"New onset conduction disturbance (NOCD)","30 days post-procedure",{"measure":73,"timeFrame":74},"Total procedure time","Procedure",{"measure":76,"timeFrame":66},"Right ventricle (RV) dysfunction","ALL","18 Years",null,false,{"inclusion":82,"exclusion":86,"raw_text":91},[83,84,85],"Age ≥18 years at the time of consent.","Severe symptomatic tricuspid regurgitation (TR) despite optimal medical therapy (OMT).","Local site multidisciplinary heart team experienced in tricuspid valve therapies agrees that the subject is appropriate for TTVR.",[87,88,89,90],"Any tricuspid device currently in place.","Anatomic contraindications.","Need for emergent or urgent surgery.","Left ventricular ejection fraction \\\u003C25%.","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%.",[93,94],"ADULT","OLDER_ADULT",[96,114,129,144],{"facility":97,"status":8,"city":98,"state":99,"zip":100,"country":101,"contacts":102,"geoPoint":111},"Abrazo Arizona Heart Hospital","Phoenix","Arizona","85016","United States",[103,108],{"name":104,"role":105,"phone":106,"email":107},"Jesica Byrne","CONTACT","602-952-0002","jessica.byrne@abrazohealth.com",{"name":109,"role":110},"Timothy Byrne, MD","PRINCIPAL_INVESTIGATOR",{"lat":112,"lon":113},33.44838,-112.07404,{"facility":115,"status":8,"city":116,"state":117,"zip":118,"country":101,"contacts":119,"geoPoint":126},"Los Robles Hospital & Medical Center","Thousand Oaks","California","91360",[120,124],{"name":121,"role":105,"phone":122,"email":123},"Jason Yashar","805-796-5881","jason.yashar@hcahealthcare.com",{"name":125,"role":110},"Saibal Kar, MD",{"lat":127,"lon":128},34.17056,-118.83759,{"facility":130,"status":8,"city":131,"state":132,"zip":133,"country":101,"contacts":134,"geoPoint":141},"Abbott Northwestern Hospital","Minneapolis","Minnesota","55407",[135,139],{"name":136,"role":105,"phone":137,"email":138},"Jennifer Nguyen","612-863-9291","jennifer.nguyen@allina.com",{"name":140,"role":110},"Konstantinos Voudris, MD",{"lat":142,"lon":143},44.97997,-93.26384,{"facility":145,"status":8,"city":146,"state":147,"zip":148,"country":101,"contacts":149,"geoPoint":156},"The Christ Hospital","Cincinnati","Ohio","45219",[150,154],{"name":151,"role":105,"phone":152,"email":153},"Jamie Elkins","513-585-1640","jamie.elkins@thechristhospital.com",{"name":155,"role":110},"Puvi Seshiah, MD",{"lat":157,"lon":158},39.12711,-84.51439,[160],{"name":161,"role":105,"phone":162,"email":163},"Amber St Martin","612-380-5637","rs.pathfinder@medtronic.com",[165,168,171,174,177],{"name":166,"affiliation":167,"role":110},"Vinayak N. Bapat, MD","Minneapolis Heart Institute",{"name":169,"affiliation":170,"role":110},"Anita Asgar, MD","Northwestern Medicine Bluhm Cardiovascular Institute",{"name":172,"affiliation":173,"role":110},"Nicolas Dumonteil, MD","Clinique Pasteur Groupe CardioVasculaire Interventionnel",{"name":175,"affiliation":176,"role":110},"Azeem Latib, MD","Montefiore Medical Center",{"name":178,"affiliation":179,"role":110},"Firas Zahr, MD","Knight Cardiovascular Institute",[],[],{"nct_id":4,"conditions":183,"biomarkers":185},[184],"Tricuspid Valve Insufficiency",[],{"nct_id":4,"found":15,"summary":187,"prompt_version":197},{"design":188,"status":189,"heading":190,"summary":191,"follow_up":192,"word_count":193,"commitments":194,"compensation":195,"drugs_mentioned":196},"This is a large, randomized controlled study comparing two different devices, planning to enroll 1186 participants.","completed","Medtronic Intrepid™ TTVR System for Severe Tricuspid Regurgitation","This study is looking at the safety and effectiveness of two devices, the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System and the Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System, for people with severe tricuspid regurgitation. Tricuspid regurgitation means the heart's tricuspid valve isn't closing properly, causing blood to leak backward. To join, you must be at least 18 years old and have severe symptoms despite other treatments. Your heart care team must also agree that this type of valve replacement is right for you. The study will measure how many major problems occur within 30 days and a combination of outcomes like death, hospital stays for heart failure, or needing another tricuspid valve procedure within one year. The current status of this study is unclear.","Participants will be followed for at least one year after the procedure to assess outcomes.",126,"Not specified in the trial record.","Not stated in the trial record.",[40,46],"v2"]