[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646864":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":19,"locations":25,"responsibleParty":43,"collaborators":10,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":10,"enrollmentInfo":55,"targetDuration":10,"studyType":58,"phases":10,"briefSummary":59,"conditions":60,"keywords":10,"overallStatus":65,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Edwards Lifesciences","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Edwards TRIFORMIS RESILIA heart valve",null,"Subjects who were treated with the Edwards TRIFORMIS RESILIA heart valve",[13],"Device: Edwards TRIFORMIS RESILIA heart valve",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":10},"DEVICE","Surgical replacement of the tricuspid valve with the Edwards TRIFORMIS RESILIA heart valve",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Aya Westbrook, PhD","CONTACT","949-250-2500","Aya_Westbrook@edwards.com",[26],{"facility":27,"status":10,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Ascension St. Vincent's Hospital","Carmel","Indiana","46260","United States","US",{"type":34,"coordinates":35},"Point",[36,37],-86.11804,39.97837,{"lat":37,"lon":36},[40],{"name":41,"role":42,"phone":10,"phoneExt":10,"email":10},"David Heimansohn, MD","PRINCIPAL_INVESTIGATOR",{"type":44,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100646864","triformis-resilia-real-world-study-assessing-safety-and-performance-triblaze-study-100646864",false,"NCT07684313","TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)","Multi-center, Single-arm, Observational Study Assessing Real-world Safety and Performance of the TRIFORMIS RESILIA Tricuspid Valve for Surgical Tricuspid Valve Replacement (TRIBLAZE Study)","TRIBLAZE","Inclusion Criteria:\n\n* 18 years or older\n* Indication for TRIFORMIS valve implant for native or prosthetic valve dysfunction\n* Provide written informed consent prior to the 30-day imaging follow-up\n* Willing and able to return for scheduled follow-up visits\n\nExclusion Criteria:\n\n• Untreatable hypersensitivity to nitinol alloys (nickel and titanium)","ALL","18 Years",{"count":56,"type":57},75,"ESTIMATED","OBSERVATIONAL","TRIBLAZE is a prospective, observational, single-arm, multicenter study designed to collect real-world clinical outcomes in a minimum of 75 participants who will receive the Edwards Lifesciences TRIFORMIS RESILIA surgical tricuspid heart valve, Model 11300T.",[61,62,63,64],"Heart Valve Diseases","Heart Diseases","Cardiovascular Diseases","Tricuspid Valve Disease","NOT_YET_RECRUITING","2026-06-29",{"date":68,"type":69},"2026-07-06","ACTUAL",{"date":71,"type":57},"2026-08",{"date":73,"type":57},"2034-12",{"name":5,"class":6},1]