[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526673":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":34,"responsibleParty":482,"collaborators":484,"id":489,"slug":490,"hasResults":491,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":491,"sex":497,"minAge":498,"maxAge":32,"enrollmentInfo":499,"targetDuration":32,"studyType":502,"phases":503,"briefSummary":505,"conditions":506,"keywords":509,"overallStatus":37,"whyStopped":32,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":520},{"fullName":5,"class":6},"P+F Products + Features USA Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TricValve® Device (Device) Group","EXPERIMENTAL","subjects will undergo TricValve® implantation and will continue to be managed with optimal medical therapies, per physician discretion.",[13],"Device: TricValve® Transcatheter Bicaval Valve System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","TricValve® Transcatheter Bicaval Valve System","The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve® Transcatheter Bicaval Valve for inferior vena cava (IVC). The system is a single use, sterile device compatible with all the valve sizes. The valves are premounted in the TricValve® Delivery System. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. The device is made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system available in sizes 25 and 29 for superior vena cava and 31 and 35 for inferior vena cava. The valve is implanted percutaneously by the transfemoral approach. The valves are supplied already premounted into the TricValve® Delivery System.",[9],[21],"TricValve System",[23],{"name":24,"affiliation":25,"role":26},"Katharina Kiss, MD","Products & Features GmbH","STUDY_CHAIR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Monica Tocchi, MD, PhD","CONTACT","9176841700",null,"m.tocchi@meditrial.net",[35,52,65,78,90,103,115,127,140,152,165,178,191,200,212,225,238,250,263,276,288,301,314,328,341,354,366,378,391,404,412,425,438,450,462,470],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"St. Joseph's Hospital and Medical Center","RECRUITING","Phoenix","Arizona","85013","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-112.07404,33.44838,{"lat":47,"lon":46},[50],{"name":51,"role":30,"phone":32,"phoneExt":32,"email":32},"Hursh Naik",{"facility":53,"status":54,"city":55,"state":39,"zip":56,"country":41,"countryCode":42,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Tucson Medical Center","NOT_YET_RECRUITING","Tucson","85712",{"type":44,"coordinates":58},[59,60],-110.92648,32.22174,{"lat":60,"lon":59},[63],{"name":64,"role":30,"phone":32,"phoneExt":32,"email":32},"Thomas Waggoner",{"facility":66,"status":37,"city":67,"state":68,"zip":69,"country":41,"countryCode":42,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Scripps Memorial Hospital La Jolla","San Diego","California","92037",{"type":44,"coordinates":71},[72,73],-117.16472,32.71571,{"lat":73,"lon":72},[76],{"name":77,"role":30,"phone":32,"phoneExt":32,"email":32},"Matthew J. Price",{"facility":79,"status":54,"city":80,"state":68,"zip":81,"country":41,"countryCode":42,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"UCSF","San Francisco","94143",{"type":44,"coordinates":83},[84,85],-122.41942,37.77493,{"lat":85,"lon":84},[88],{"name":89,"role":30,"phone":32,"phoneExt":32,"email":32},"Sammy Elmariah",{"facility":91,"status":54,"city":92,"state":93,"zip":94,"country":41,"countryCode":42,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Delray Medical Center","Delray Beach","Florida","33484",{"type":44,"coordinates":96},[97,98],-80.07282,26.46146,{"lat":98,"lon":97},[101],{"name":102,"role":30,"phone":32,"phoneExt":32,"email":32},"Tilak Pasala",{"facility":104,"status":37,"city":105,"state":93,"zip":106,"country":41,"countryCode":42,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Largo Medical Center","Largo","33770",{"type":44,"coordinates":108},[109,110],-82.78842,27.90979,{"lat":110,"lon":109},[113],{"name":114,"role":30,"phone":32,"phoneExt":32,"email":32},"Saurabh Sanon",{"facility":116,"status":37,"city":117,"state":93,"zip":118,"country":41,"countryCode":42,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Tampa General Hospital","Tampa","33606",{"type":44,"coordinates":120},[121,122],-82.45843,27.94752,{"lat":122,"lon":121},[125],{"name":126,"role":30,"phone":32,"phoneExt":32,"email":32},"Hiram Bezerra",{"facility":128,"status":37,"city":129,"state":130,"zip":131,"country":41,"countryCode":42,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Endeavor Health, Glenbrook Hospital","Glenview","Illinois","60026",{"type":44,"coordinates":133},[134,135],-87.78784,42.06975,{"lat":135,"lon":134},[138],{"name":139,"role":30,"phone":32,"phoneExt":32,"email":32},"Mark J. Ricciardi",{"facility":141,"status":54,"city":142,"state":130,"zip":143,"country":41,"countryCode":42,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Chicago Advocate Christ","Palos Park","60464",{"type":44,"coordinates":145},[146,147],-87.83033,41.66725,{"lat":147,"lon":146},[150],{"name":151,"role":30,"phone":32,"phoneExt":32,"email":32},"Ravi Ramana",{"facility":153,"status":37,"city":154,"state":155,"zip":156,"country":41,"countryCode":42,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Ascension Medical Group St. Vincent The Heart Center of Indiana","Indianapolis","Indiana","46260",{"type":44,"coordinates":158},[159,160],-86.15804,39.76838,{"lat":160,"lon":159},[163],{"name":164,"role":30,"phone":32,"phoneExt":32,"email":32},"James Hermiller",{"facility":166,"status":37,"city":167,"state":168,"zip":169,"country":41,"countryCode":42,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Cardiovascular Institute of the South","Houma","Louisiana","70360",{"type":44,"coordinates":171},[172,173],-90.71953,29.59577,{"lat":173,"lon":172},[176],{"name":177,"role":30,"phone":32,"phoneExt":32,"email":32},"Peter Fail",{"facility":179,"status":37,"city":180,"state":181,"zip":182,"country":41,"countryCode":42,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":44,"coordinates":184},[185,186],-71.05977,42.35843,{"lat":186,"lon":185},[189],{"name":190,"role":30,"phone":32,"phoneExt":32,"email":32},"Dhaval Kolte",{"facility":192,"status":54,"city":180,"state":181,"zip":193,"country":41,"countryCode":42,"cosmosGeoPoint":194,"geoPoint":196,"contacts":197},"Beth Israel Deaconess Medical Center","02215",{"type":44,"coordinates":195},[185,186],{"lat":186,"lon":185},[198],{"name":199,"role":30,"phone":32,"phoneExt":32,"email":32},"Roger Laham",{"facility":201,"status":37,"city":202,"state":181,"zip":203,"country":41,"countryCode":42,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"Lahey Hospital & Medical Center","Burlington","01805",{"type":44,"coordinates":205},[206,207],-71.19561,42.50482,{"lat":207,"lon":206},[210],{"name":211,"role":30,"phone":32,"phoneExt":32,"email":32},"Gautam Gadey",{"facility":213,"status":37,"city":214,"state":215,"zip":216,"country":41,"countryCode":42,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"Minneapolis Heart Institute Foundation","Minneapolis","Minnesota","55407",{"type":44,"coordinates":218},[219,220],-93.26384,44.97997,{"lat":220,"lon":219},[223],{"name":224,"role":30,"phone":32,"phoneExt":32,"email":32},"Paul Sorajja",{"facility":226,"status":54,"city":227,"state":228,"zip":229,"country":41,"countryCode":42,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"Saint Luke's Mid America Heart Institute","Kansas City","Missouri","64111",{"type":44,"coordinates":231},[232,233],-94.57857,39.09973,{"lat":233,"lon":232},[236],{"name":237,"role":30,"phone":32,"phoneExt":32,"email":32},"Adnon Chhatriwalla",{"facility":239,"status":54,"city":240,"state":228,"zip":241,"country":41,"countryCode":42,"cosmosGeoPoint":242,"geoPoint":246,"contacts":247},"Washington University St Louis","St Louis","63110",{"type":44,"coordinates":243},[244,245],-90.19789,38.62727,{"lat":245,"lon":244},[248],{"name":249,"role":30,"phone":32,"phoneExt":32,"email":32},"Alan Zajarias",{"facility":251,"status":54,"city":252,"state":253,"zip":254,"country":41,"countryCode":42,"cosmosGeoPoint":255,"geoPoint":259,"contacts":260},"Hackensack University Medical Center","Hackensack","New Jersey","07601",{"type":44,"coordinates":256},[257,258],-74.04347,40.88593,{"lat":258,"lon":257},[261],{"name":262,"role":30,"phone":32,"phoneExt":32,"email":32},"Ryan Kaple",{"facility":264,"status":54,"city":265,"state":266,"zip":267,"country":41,"countryCode":42,"cosmosGeoPoint":268,"geoPoint":272,"contacts":273},"North Shore University Hospital","Manhasset","New York","11030",{"type":44,"coordinates":269},[270,271],-73.69957,40.79788,{"lat":271,"lon":270},[274],{"name":275,"role":30,"phone":32,"phoneExt":32,"email":32},"Bruce Rutkin",{"facility":277,"status":37,"city":278,"state":266,"zip":279,"country":41,"countryCode":42,"cosmosGeoPoint":280,"geoPoint":284,"contacts":285},"Montefiore Medical Center","The Bronx","10467",{"type":44,"coordinates":281},[282,283],-73.86641,40.84985,{"lat":283,"lon":282},[286],{"name":287,"role":30,"phone":32,"phoneExt":32,"email":32},"Edwin Ho",{"facility":289,"status":54,"city":290,"state":291,"zip":292,"country":41,"countryCode":42,"cosmosGeoPoint":293,"geoPoint":297,"contacts":298},"Duke Cardiology Clinic","Durham","North Carolina","27710",{"type":44,"coordinates":294},[295,296],-78.89862,35.99403,{"lat":296,"lon":295},[299],{"name":300,"role":30,"phone":32,"phoneExt":32,"email":32},"Marat Fudim",{"facility":302,"status":37,"city":303,"state":304,"zip":305,"country":41,"countryCode":42,"cosmosGeoPoint":306,"geoPoint":310,"contacts":311},"Cleveland Clinic","Cleveland","Ohio","44106",{"type":44,"coordinates":307},[308,309],-81.69541,41.4995,{"lat":309,"lon":308},[312],{"name":313,"role":30,"phone":32,"phoneExt":32,"email":32},"Rishi Puri, MD",{"facility":315,"status":54,"city":316,"state":304,"zip":317,"country":41,"countryCode":42,"cosmosGeoPoint":318,"geoPoint":322,"contacts":323},"Riverside Methodist Hospital","Columbus","43214",{"type":44,"coordinates":319},[320,321],-82.99879,39.96118,{"lat":321,"lon":320},[324,326],{"name":325,"role":30,"phone":32,"phoneExt":32,"email":32},"Carlos Sanchez",{"name":327,"role":30,"phone":32,"phoneExt":32,"email":32},"Steve Yakubuv",{"facility":329,"status":54,"city":330,"state":331,"zip":332,"country":41,"countryCode":42,"cosmosGeoPoint":333,"geoPoint":337,"contacts":338},"Oregon Health Services","Portland","Oregon","97239",{"type":44,"coordinates":334},[335,336],-122.67621,45.52345,{"lat":336,"lon":335},[339],{"name":340,"role":30,"phone":32,"phoneExt":32,"email":32},"Firas Zahr",{"facility":342,"status":37,"city":343,"state":344,"zip":345,"country":41,"countryCode":42,"cosmosGeoPoint":346,"geoPoint":350,"contacts":351},"UPMC Pinnacle","Harrisburg","Pennsylvania","17107",{"type":44,"coordinates":347},[348,349],-76.88442,40.2737,{"lat":349,"lon":348},[352],{"name":353,"role":30,"phone":32,"phoneExt":32,"email":32},"Hemal Gada",{"facility":355,"status":54,"city":356,"state":344,"zip":357,"country":41,"countryCode":42,"cosmosGeoPoint":358,"geoPoint":362,"contacts":363},"UPMC Presbyterian Shadyside","Pittsburgh","15232",{"type":44,"coordinates":359},[360,361],-79.99589,40.44062,{"lat":361,"lon":360},[364],{"name":365,"role":30,"phone":32,"phoneExt":32,"email":32},"Catalin Toma",{"facility":367,"status":54,"city":368,"state":344,"zip":369,"country":41,"countryCode":42,"cosmosGeoPoint":370,"geoPoint":374,"contacts":375},"WellSpan York Hospital","York","17403",{"type":44,"coordinates":371},[372,373],-76.72774,39.9626,{"lat":373,"lon":372},[376],{"name":377,"role":30,"phone":32,"phoneExt":32,"email":32},"James Harvey",{"facility":379,"status":54,"city":380,"state":381,"zip":382,"country":41,"countryCode":42,"cosmosGeoPoint":383,"geoPoint":387,"contacts":388},"MUSC","Charleston","South Carolina","29425",{"type":44,"coordinates":384},[385,386],-79.93275,32.77632,{"lat":386,"lon":385},[389],{"name":390,"role":30,"phone":32,"phoneExt":32,"email":32},"Nicholas Amoroso",{"facility":392,"status":37,"city":393,"state":394,"zip":395,"country":41,"countryCode":42,"cosmosGeoPoint":396,"geoPoint":400,"contacts":401},"Houston Methodist","Houston","Texas","77030",{"type":44,"coordinates":397},[398,399],-95.36327,29.76328,{"lat":399,"lon":398},[402],{"name":403,"role":30,"phone":32,"phoneExt":32,"email":32},"Sachin Goel",{"facility":405,"status":37,"city":393,"state":394,"zip":395,"country":41,"countryCode":42,"cosmosGeoPoint":406,"geoPoint":408,"contacts":409},"University of Texas (Memorial Hermann)",{"type":44,"coordinates":407},[398,399],{"lat":399,"lon":398},[410],{"name":411,"role":30,"phone":32,"phoneExt":32,"email":32},"Biswajit Kar",{"facility":413,"status":37,"city":414,"state":415,"zip":416,"country":41,"countryCode":42,"cosmosGeoPoint":417,"geoPoint":421,"contacts":422},"Intermountain Heart Institute - Intermountain Medical Center","Murray","Utah","84107",{"type":44,"coordinates":418},[419,420],-111.88799,40.66689,{"lat":420,"lon":419},[423],{"name":424,"role":30,"phone":32,"phoneExt":32,"email":32},"Brian Whisenant",{"facility":426,"status":37,"city":427,"state":428,"zip":429,"country":41,"countryCode":42,"cosmosGeoPoint":430,"geoPoint":434,"contacts":435},"UVA School of Medicine","Charlottesville","Virginia","22903",{"type":44,"coordinates":431},[432,433],-78.47668,38.02931,{"lat":433,"lon":432},[436],{"name":437,"role":30,"phone":32,"phoneExt":32,"email":32},"John Saxon",{"facility":439,"status":54,"city":440,"state":428,"zip":441,"country":41,"countryCode":42,"cosmosGeoPoint":442,"geoPoint":446,"contacts":447},"Sentara Healthcare","Norfolk","23507",{"type":44,"coordinates":443},[444,445],-76.28522,36.84681,{"lat":445,"lon":444},[448],{"name":449,"role":30,"phone":32,"phoneExt":32,"email":32},"Matthew Summers",{"facility":451,"status":54,"city":452,"state":428,"zip":453,"country":41,"countryCode":42,"cosmosGeoPoint":454,"geoPoint":458,"contacts":459},"Carilion Clinic","Roanoke","24014",{"type":44,"coordinates":455},[456,457],-79.94143,37.27097,{"lat":457,"lon":456},[460],{"name":461,"role":30,"phone":32,"phoneExt":32,"email":32},"Jason Foerst",{"facility":463,"status":37,"city":464,"state":465,"zip":466,"country":41,"countryCode":42,"cosmosGeoPoint":32,"geoPoint":32,"contacts":467},"MedStar Washington Hospital Center","Multiple Locations","Washington","20010",[468],{"name":469,"role":30,"phone":32,"phoneExt":32,"email":32},"Toby Rogers",{"facility":471,"status":54,"city":472,"state":465,"zip":473,"country":41,"countryCode":42,"cosmosGeoPoint":474,"geoPoint":478,"contacts":479},"Swedish Medical Center","Seattle","98122",{"type":44,"coordinates":475},[476,477],-122.33207,47.60621,{"lat":477,"lon":476},[480],{"name":481,"role":30,"phone":32,"phoneExt":32,"email":32},"Sameer Gafoor",{"type":483,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[485,487],{"name":486,"class":6},"P+F Products + Features GmbH",{"name":488,"class":6},"Meditrial USA Inc.","100526673","tricvalve-bicaval-valve-system-for-severe-tricuspid-regurgitation-tricav-i-100526673",false,"NCT06137807","TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)","A Prospective, Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation - TRICAV-I Trial","TRICAV-I","Inclusion Criteria:\n\n1. Subject must be 18 years or older, at the time of signing the informed consent.\n2. Subjects has severe tricuspid regurgitation (TR), as determined by the qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography Core Lab.\n3. NYHA Class III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months.\n4. Subject is adequately treated with optimal medical therapy (OMT) for heart failure per the local Heart Team for at least 30 days prior to the index procedure, including a diuretic.\n5. The local Heart Team and IEC determine that the patient is eligible for the TricValve procedure.\n6. For females of childbearing potential, negative pregnancy test.\n7. Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n1. Subject had a recent MI, stroke or cardiovascular accident; underwent coronary artery bypass graft surgery, had a percutaneous coronary intervention or other major cardiovascular surgery within 90 days prior to TricValve implantation.\n2. Subject requires another planned major cardiac procedure, including left-sided transcatheter intervention or surgery (e.g. severe aortic stenosis, severe mitral regurgitation), coronary artery bypass or PCI or pulmonary valve correction. Please note that if closure of an ASD, iatrogenic ASD or PFO is performed, TricValve implantation can be performed 30 days after the intervention. Additionally, TricValve implantation can be performed 30 days after any Electrophysiology procedure (pacemaker, ICD, etc.).\n3. LVEF ≤ 30% on echocardiography.\n4. Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.\n5. Tricuspid stenosis. (Per TVARC, echo criteria: TVA at least 1.5 cm2 or TVAi at least 0.9 cm2\u002Fm2 \\[at least 0.75 if BMI \\>30 kg\u002Fm2\\], DVI \\\u003C2.2, mean gradient \\\u003C5mm Hg); reduction of total tricuspid regurgitation to optimal (≤ mild \\[1+\\]) or acceptable (≤ moderate \\[2+\\]).\n6. Severe right ventricular dysfunction.\n7. Cardiac amyloidosis\n8. Pulmonary artery systolic pressure (PASP) \\>65 mmHg assessed with Echo Doppler and \u002For right heart catheterization.\n9. Lower extremity venous thrombosis and\u002For the presence of an IVC filter at the time of or 6 months prior to TricValve procedure.\n10. Hemodynamically significant pericardial effusion.\n11. Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) (ACC\u002F AHA\u002F ESC\u002F EACTS Stage D heart failure)\n12. Any known allergy or hypersensitivity to nitinol, bovine tissue or contrast media that cannot be adequately treated with pre-medication.\n13. Unable to tolerate anticoagulation\u002Fantiplatelet therapy\n14. Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloon pump or acute heart failure within 30 days prior to the TricValve procedure.\n15. Any known life-threatening condition with an estimated life span of at least 12 months.\n16. Platelet count \\\u003C 75,000\u002Fmm3\n17. Child-Pugh Severity Class C (10-15 points).\n18. Severe renal insufficiency with estimated glomerular filtration rate (eGFR) ≤ 25 mL\u002Fmin\u002F1.73 m2 or requiring chronic renal replacement therapy at the time of enrollment.\n19. Endocarditis or active\u002Fongoing infection requiring antibiotics.\n20. Unable to walk at least 60 meters in a 6minute walk test.\n21. Known bleeding or clotting disorders or patient refuses blood transfusion.\n22. Active gastrointestinal (GI) bleeding within 3 months of randomization.\n23. Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.\n24. Use or participation in other investigational device or drug study in which patient has not reached a primary endpoint to treat cardiovascular conditions related to the outcomes of the current study.\n25. Any other condition that would preclude ability to meet study requirements in the opinion of the investigator.\n26. Psychiatric\u002Fbehavioral issues or other medical or social conditions that preclude valid consent and follow-up\n27. Pregnant or breastfeeding subjects and those who plan pregnancy during the clinical investigation follow-up period.","ALL","18 Years",{"count":500,"type":501},50,"ESTIMATED","INTERVENTIONAL",[504],"NA","The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve® Transcatheter Bicaval Valve for inferior vena cava (IVC). The TricValve® Transcatheter Bicaval Valves are pre-mounted into the TricValve® Delivery System which is used for percutaneous access and delivery of the TricValve® Transcatheter Bicaval Valve in the vena cava. The system is a single use, sterile device compatible with all the valve sizes. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. The device is made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system.",[507,508],"Tricuspid Regurgitation","Tricuspid Valve Disease",[507,510],"Heart Failure","2025-06-04",{"date":513,"type":514},"2025-06-08","ACTUAL",{"date":516,"type":514},"2024-07-23",{"date":518,"type":501},"2029-09",{"name":5,"class":6},36]