[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646626":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":34,"centralContacts":45,"locations":30,"responsibleParty":51,"collaborators":30,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":30,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":30,"overallStatus":79,"whyStopped":30,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":30},{"fullName":5,"class":6},"Laplace Interventional, Inc","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Laplace TTVR System","EXPERIMENTAL","Transcatheter tricuspid valve replacement with the Laplace TTVR System in patients with severe or greater TR.",[13],"Device: Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System",{"label":15,"type":16,"description":17,"interventionNames":18},"Edwards EVOQUE TTVR","ACTIVE_COMPARATOR","Transcatheter tricuspid valve replacement with the Edwards EVOQUE TTVR in patients with severe or greater TR.",[19],"Device: Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System",{"label":21,"type":10,"description":22,"interventionNames":23},"Laplace TTVR System Single Arm Cohort","Transcatheter tricuspid valve replacement with Laplace TTVR System in patients with severe or greater tricuspid regurgitation who are deemed ineligible to be treated with the Active Comparator EVOQUE TTVR and are suboptimal T-TEER candidates.",[13],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","Transcatheter Tricuspid Valve Replacement (TTVR) with Laplace TTVR System","Transcatheter Tricuspid Valve Replacement",[9,21],null,{"type":26,"name":32,"description":28,"armGroupLabels":33,"otherNames":30},"Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE TTVR System",[15],[35,39,42],{"name":36,"affiliation":37,"role":38},"Kashish Goel, MD","Vanderbilt University Medical Center","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":41,"role":38},"Brandon Jones, MD","Providence St. Vincent Medical Center",{"name":43,"affiliation":44,"role":38},"Charanjit Rihal, MD","Mayo Clinic",[46],{"name":47,"role":48,"phone":49,"phoneExt":30,"email":50},"Ryan Gladney","CONTACT","763-710-3539","clinical@laplaceint.com",{"type":52,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100646626","tricuspid-regurgitation-treatment-with-laplace-transcatheter-tricuspid-valve-replacement-system-100646626",false,"NCT07687485","Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System","TRIUMPH","Inclusion Criteria:\n\n* 18 - 90 years of age at the time of the study procedure.\n* Symptomatic TR despite being adequately treated with OMT by the Local Heart Team for at least 30 days prior to the time of study consent.\n* Severe, massive or torrential tricuspid regurgitation determined by qualifying echocardiogram using the 5-grade classification.\n* Candidate felt suitable for transcatheter tricuspid valve replacement as determined by the local Heart Team and confirmed by the patient selection committee.\n* Subject has provided informed consent and agrees to return for all required post-procedure follow-up visits.\n* Anatomically suitable for the Laplace TTVR system.\n\nExclusion Criteria:\n\n* Estimated life expectancy of less than 12 months.\n* Need for emergent, urgent or planned surgery or intervention within 30 days following the study procedure. Planned or scheduled cardiac surgery within next 12 months.\n* Severe renal insufficiency defined as eGFR \\\u003C25 mL\u002Fmin or requiring chronic renal replacement therapy at the time of screening committee review.\n* Current history (within last 5 years) of illicit drug use.\n* Stroke or other major cerebrovascular event within 90-days prior to index procedure.\n* Current or planned pregnancy within next 12 months for women of childbearing potential.\n* Participation in another pre-market investigational device study or investigational drug study for a cardiac related drug.\n* Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements. Any patient considered to be vulnerable.\n* Anatomically unsuitable for the Laplace TTVR System","ALL","18 Years","90 Years",{"count":64,"type":65},700,"ESTIMATED","INTERVENTIONAL",[68],"NA","The objective of this clinical study is to assess the safety and efficacy of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System for the treatment of symptomatic subjects with at least severe tricuspid regurgitation (TR).",[71,72,73,74,75,76,77,78],"Severe Tricuspid Valve Regurgitation","Tricuspid Valve Regurgitation","Tricuspid Valve Disease","Cardiovascular Diseases (CVD)","Heart Valve Diseases","Tricuspid Valve Insufficiency","Severe Heart Valve Disease","Symptomatic Tricuspid Regurgitation","NOT_YET_RECRUITING","2026-07-21",{"date":82,"type":83},"2026-07-22","ACTUAL",{"date":85,"type":65},"2026-09",{"date":87,"type":65},"2038-09",{"name":5,"class":6}]