[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06458907":3,"trial-entities:NCT06458907":416,"trial-summary:NCT06458907":419},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":24,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":49,"secondary_outcomes":67,"sex":118,"minimum_age":119,"maximum_age":120,"healthy_volunteers":121,"eligibility_criteria":122,"std_ages":126,"locations":129,"central_contacts":394,"overall_officials":399,"references":400,"see_also_links":409},"NCT06458907","CTP-TRIC-005-II","A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.","NOT_YET_RECRUITING","2032-11","2026-07","2026-08-03","2026-08","P+F Products + Features USA Inc.","INDUSTRY",true,"Pivotal trial to evaluate the safety and effectiveness of the P\\&F TricValve® Transcatheter Bicaval Valve System.","The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the TricValve System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with severe tricuspid regurgitation and unsuitable for approved transcatheter therapies. Subjects will be followed at discharge, 1 month, 30 days, 3 months, 6 months 12 months, and annually up to 5 years.",[18,19,20,21,22,23],"Tricuspid Valve Disease","Heart Valve Diseases","Cardiovascular Diseases","Heart Failure","Tricuspid Valve Regurgitation","Tricuspid Valve Insufficiency",[],"INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},780,"ESTIMATED",[33,42],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":40},"DEVICE","TricValve System","• Heterotopic Transcatheter Valve Replacement (TVR) with the TricValve System in conjunction with optimal medical therapy",[38,39],"TricValve Single Arm Registry","TricValve System + Optimal medical therapy (OMT)",[41],"Heterotopic caval valve implantation (CAVI)",{"type":43,"name":44,"description":44,"armGroupLabels":45,"otherNames":47},"DRUG","Optimal medical therapy",[46,38,39],"Optimal medical therapy (OMT) Alone",[48],"OMT",[50,54,57,61,64],{"measure":51,"description":52,"timeFrame":53},"Randomized Cohort: Caval Reflux (CR) grade reduction","Reduction in Caval Reflux (CR) assessed by the echocardiography core laboratory. The CR will be assessed using the 3-grade scale: Grade 1 (no reflux, reflux extending for less than 1 cm below the diaphragm), Grade 2 ( reflux extending for less than 3 cm), Grade 3 (reflux of 3 cm or more). Lower grades of CR are better.","6 months",{"measure":55,"description":56,"timeFrame":53},"Randomized Cohort: Hierarchical composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement","Comparison of clinical outcomes using a single hierarchical analysis. Treatment effect will be summarized using Win Ratio statistics, where a value greater than 1 indicates improved outcomes in the experimental group compared with the comparator arm.",{"measure":58,"description":59,"timeFrame":60},"Randomized Cohort: Rate of Major Adverse Events (MAE)","Rate of Major Adverse Events (MAE) in experimental arm (TricValve + OMT)","30 days",{"measure":62,"description":56,"timeFrame":63},"Randomized Cohort: Hierarchical composite endpoint: all-cause mortality, RVAD implantation or heart transplant, tricuspid valve surgery or percutaneous tricuspid intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improv","1 year",{"measure":65,"description":66,"timeFrame":60},"Registry Cohort: Rate of Major Adverse Events (MAE)","Rate of Major Adverse Events (MAE) in single arm registry",[68,71,75,78,81,84,87,90,93,96,99,101,103,106,108,110,113,116],{"measure":69,"description":70,"timeFrame":63},"Randomized Cohort: Percentage of Device- and\u002For Procedure-related MAEs","Rate of Major Adverse Events",{"measure":72,"description":73,"timeFrame":74},"Randomized Cohort: All-Cause mortality and Cardiovascular Mortality","Number of deaths from any cause as well as cardiovascular events","6 months and 1 year",{"measure":76,"description":77,"timeFrame":74},"Randomized Cohort: Heart Failure Hospitalizations (HFH)","Number of Heart Failure Hospitalizations and worsening HF events without hospitilization",{"measure":79,"description":80,"timeFrame":74},"Randomized Cohort: RVAD Implantation or Heart Transplant","Number of patients requiring RVAD Implantation or Heart Transplant",{"measure":82,"description":83,"timeFrame":63},"Randomized Cohort: Atrial Fibrillation","New onset of atrial fibrillation",{"measure":85,"description":86,"timeFrame":74},"Randomized Cohort: Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) .","Improvement of at least 10 points from baseline. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better Quality of Life (QOL)",{"measure":88,"description":89,"timeFrame":74},"Randomized Cohort: Changes in symptom status New York Heart Association (NYHA class)","Reduction of at least 1 class from baseline. The NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest).",{"measure":91,"description":92,"timeFrame":74},"Randomized Cohort: Changes in functional capacity (6-minute walk test, 6MWT).","Improvement of 6-minute walk distance of at least 30 meters from baseline.",{"measure":94,"description":95,"timeFrame":63},"Registry Cohort: Heart Failure Hospitalization","Comparison of the 12-month post-procedure HFH rate with the 12-month pre-procedure rate",{"measure":97,"description":98,"timeFrame":63},"Registry Cohort: Changes in Quality of life (by Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score).","Change from baseline to 12 months. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better Quality of Life (QOL)",{"measure":100,"description":70,"timeFrame":63},"Roll-In Cohort: Percentage of Device- and\u002For Procedure-related MAEs",{"measure":102,"description":73,"timeFrame":74},"Roll-In Cohort: All-Cause mortality and Cardiovascular Mortality",{"measure":104,"description":105,"timeFrame":74},"Roll-In Cohort: Heart Failure Hospitalizations (HFH)","Number of Heart Failure Hospitalizations and worsening HF events without hospitalization",{"measure":107,"description":80,"timeFrame":74},"Roll-In Cohort: RVAD Implantation or Heart Transplant",{"measure":109,"description":83,"timeFrame":63},"Roll-In Cohort: Atrial Fibrillation",{"measure":111,"description":112,"timeFrame":74},"Roll-In Cohort: Quality of life as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ).","Improvement of at least 10 points from baseline. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better Quality of Life",{"measure":114,"description":115,"timeFrame":74},"Roll-In Cohort: New York Heart Association (NYHA) functional class","Reduction of at least 1 class from baseline. NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest).",{"measure":117,"description":92,"timeFrame":74},"Roll-In Cohort: 6-minute walk test (6MWT).","ALL","18 Years","85 Years",false,{"inclusion":123,"exclusion":124,"raw_text":125},[],[],"Eligibility Criteria for Randomized Cohort:\n\nInclusion Criteria:\n\n1. Age between 18 years and 85 years old, at the time of signing the informed consent.\n2. Severe tricuspid regurgitation (TR) and Caval Reflux (CR), as determined by the qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography Core Lab. TVARC criteria will be used for the definition of TR severity.\n3. NYHA Class II-III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months.\n4. Adequately treated with optimal medical therapy (OMT) for heart failure per the local Heart Team at the time of TR assessment for eligibility (TTE). OMT includes stable oral diuretic medications.\n5. High risk for open surgery and is appropriate for transcatheter tricuspid therapies according to the local heart team.\n6. Patient is unsuitable for approved transcatheter therapies and is eligible for the TricValve procedure, based on review of screening\u002Fbaseline data and imaging core lab measurements by Central Screening Committee.\n7. For females of childbearing potential, negative pregnancy test.\n8. Capable and willing to provide signed informed consent\n\nExclusion Criteria:\n\nCONCOMITANT PROCEDURES\n\n1. Patient 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. Patient 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.\n\n   CARDIOVASCULAR CONDITIONS\n3. LVEF ≤ 30% on echocardiography.\n4. Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.\n5. Severe right ventricular dysfunction.\n6. Cardiac amyloidosis.\n7. Pulmonary artery systolic pressure (PASP) \\>65 mmHg assessed with Echo Doppler and \u002For right heart catheterization.\n8. Lower extremity venous thrombosis and\u002For the presence of an IVC filter at the time of or 6 months prior to the TricValve procedure.\n9. Hemodynamically significant pericardial effusion.\n10. Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloon pump or acute heart failure within 30 days prior to the TricValve procedure.\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. Presence of significant congenital or acquired heart disease such as RV dysplasia, arrhythmogenic RV or other conditions that could interfere with the TricValve procedure.\n\n    ALLERGIES \u002F INTOLERANCE\n13. Any known allergy or hypersensitivity to nitinol, bovine tissue, or contrast media that cannot be adequately treated with pre-medication.\n14. Unable to tolerate anticoagulation\u002Fantiplatelet therapy\n\n    COMORBIDITIES\n15. Any known life-threatening condition with an estimated life span of less than 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) ≤ 30 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 100 meters in a 6-minute walk test.\n21. Known bleeding or clotting disorders or patient refuses blood transfusion.\n22. Active gastrointestinal (GI) bleeding within 3 months of TricValve procedure.\n23. Prior Malignancy: this study excludes participants at material risk of near-term cancer-related morbidity\u002Fmortality that could confound 12-month outcomes. This study allows the inclusion of fully treated, remote malignancies with documented No Evidence of Disease (NED)\" criteria\n\n    a. History of any malignancy within 5 years prior to randomization or any active malignancy, except: i. Adequately treated non-melanoma skin cancer (basal or squamous cell) with no evidence of disease, or ii. Carcinoma in situ (e.g., cervical, breast DCIS) treated with curative intent and no evidence of disease.\n\n    b. Participants with a prior malignancy diagnosed \\>5 years before randomization are eligible if they meet all of the \"No Evidence of Disease (NED)\" criteria as specified below: i. No signs\u002Fsymptoms of cancer on history and physical exam per standard of care; ii. No radiologic evidence of disease on surveillance imaging if such imaging is routinely indicated for that tumor type (not protocol-mandated); iii. Tumor markers (if applicable for that cancer) not suggestive of recurrence (e.g., stable\u002Fundetectable within site's lab reference and oncologist's judgment); iv. No active anti-cancer therapy (cytotoxic chemotherapy, immunotherapy, targeted therapy, radiotherapy) and none planned; v. Treating oncologist's attestation (or primary physician if oncology follow-up is complete) that the participant is disease-free and appropriate for participation.\n\n    GENERAL EXCLUSIONS\n24. Use or participation in other investigational device or drug study in which the 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 the 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.\n\nEligibility Criteria for Single Arm Cohort:\n\nInclusion Criteria:\n\n1. Age \\> 85 years.\n2. NYHA Class III-IV, on intravenous inotropes, IABP or LVAD.\n3. LVEF ≤ 30% on echocardiography.\n4. Severe RV dysfunction.\n5. Severe pulmonary hypertension (PH), defined as Pulmonary artery systolic pressure (PASP) \\>65 mmHg assessed with Echo Doppler and \u002For mean Pulmonary Artery Pressure (mPAP \\>35) by right heart catheterization.\n6. Renal insufficiency: eGFR between 25 and 30 mL\u002Fmin\u002F 1.73 m² or on chronic renal replacement therapy.\n7. Patient unable to walk a minimum distance of 100 mt during 6 minute walk test.\n8. Prior malignancy not meeting the requirements applied for the Randomized Cohort, specified in Exclusion Criterion #23.\n9. Comorbidities precluding inclusion in the Randomized Cohort (exclusion criteria #15 to #24).",[127,128],"ADULT","OLDER_ADULT",[130,139,147,155,162,169,176,191,199,209,216,224,232,240,248,256,260,267,275,282,289,297,305,312,323,330,338,346,354,357,364,372,380,387],{"facility":131,"city":132,"state":133,"zip":134,"country":135,"geoPoint":136},"University of Alabama","Birmingham","Alabama","35233","United States",{"lat":137,"lon":138},33.52066,-86.80249,{"facility":140,"city":141,"state":142,"zip":143,"country":135,"geoPoint":144},"St. Joseph's Hospital and Medical Center","Phoenix","Arizona","85013",{"lat":145,"lon":146},33.44838,-112.07404,{"facility":148,"city":149,"state":150,"zip":151,"country":135,"geoPoint":152},"UC Davis Health","Sacramento","California","95817",{"lat":153,"lon":154},38.58157,-121.4944,{"facility":156,"city":157,"state":150,"zip":158,"country":135,"geoPoint":159},"Scripps Memorial Hospital La Jolla","San Diego","92037",{"lat":160,"lon":161},32.71571,-117.16472,{"facility":163,"city":164,"state":150,"zip":165,"country":135,"geoPoint":166},"UCSF","San Francisco","94143",{"lat":167,"lon":168},37.77493,-122.41942,{"facility":170,"city":171,"state":150,"zip":172,"country":135,"geoPoint":173},"Kaiser Permanente","San Jose","94118",{"lat":174,"lon":175},37.33939,-121.89496,{"facility":177,"city":178,"state":179,"zip":180,"country":135,"contacts":181,"geoPoint":188},"MedStar Washington Hospital Center (MWHC)","Washington D.C.","District of Columbia","20010",[182,185],{"name":183,"role":184},"Erin Collins","CONTACT",{"name":186,"role":187},"Toby Rogers, MD","PRINCIPAL_INVESTIGATOR",{"lat":189,"lon":190},38.89511,-77.03637,{"facility":192,"city":193,"state":194,"zip":195,"country":135,"geoPoint":196},"Delray Medical Center","Delray Beach","Florida","33484",{"lat":197,"lon":198},26.46146,-80.07282,{"facility":200,"city":201,"state":194,"zip":202,"country":135,"contacts":203,"geoPoint":206},"HCA Florida Largo Hospital","Largo","33770",[204],{"name":205,"role":187},"Saurabh Sanon, MD",{"lat":207,"lon":208},27.90979,-82.78842,{"facility":210,"city":211,"state":194,"zip":212,"country":135,"geoPoint":213},"Tampa General Hospital","Tampa","33606",{"lat":214,"lon":215},27.94752,-82.45843,{"facility":217,"city":218,"state":219,"zip":220,"country":135,"geoPoint":221},"Endeavor Health","Glenview","Illinois","60026",{"lat":222,"lon":223},42.06975,-87.78784,{"facility":225,"city":226,"state":227,"zip":228,"country":135,"geoPoint":229},"Ascension Medical Group St. Vincent The Heart Center of Indiana","Indianapolis","Indiana","46260",{"lat":230,"lon":231},39.76838,-86.15804,{"facility":233,"city":234,"state":235,"zip":236,"country":135,"geoPoint":237},"University of Kansas Medical Center","Kansas City","Kansas","66103",{"lat":238,"lon":239},39.11417,-94.62746,{"facility":241,"city":242,"state":243,"zip":244,"country":135,"geoPoint":245},"Cardiovascular Institute of the South","Houma","Louisiana","70360",{"lat":246,"lon":247},29.59577,-90.71953,{"facility":249,"city":250,"state":251,"zip":252,"country":135,"geoPoint":253},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"lat":254,"lon":255},42.35843,-71.05977,{"facility":257,"city":250,"state":251,"zip":258,"country":135,"geoPoint":259},"Beth Israel Deaconess Medical Center","02215",{"lat":254,"lon":255},{"facility":261,"city":262,"state":251,"zip":263,"country":135,"geoPoint":264},"Lahey Hospital & Medical Center","Burlington","01805",{"lat":265,"lon":266},42.50482,-71.19561,{"facility":268,"city":269,"state":270,"zip":271,"country":135,"geoPoint":272},"Minneapolis Heart Institute Foundation","Minneapolis","Minnesota","55407",{"lat":273,"lon":274},44.97997,-93.26384,{"facility":276,"city":234,"state":277,"zip":278,"country":135,"geoPoint":279},"Saint Luke's Mid America Heart Institute","Missouri","64111",{"lat":280,"lon":281},39.09973,-94.57857,{"facility":283,"city":284,"state":277,"zip":285,"country":135,"geoPoint":286},"Washington University of St Louis","St Louis","63110",{"lat":287,"lon":288},38.62727,-90.19789,{"facility":290,"city":291,"state":292,"zip":293,"country":135,"geoPoint":294},"Hackensack University Medical Center","Hackensack","New Jersey","07601",{"lat":295,"lon":296},40.88593,-74.04347,{"facility":298,"city":299,"state":300,"zip":301,"country":135,"geoPoint":302},"Northwell Hospital","Manhasset","New York","11030",{"lat":303,"lon":304},40.79788,-73.69957,{"facility":306,"city":307,"state":300,"zip":308,"country":135,"geoPoint":309},"Montefiore Medical Center","The Bronx","10467",{"lat":310,"lon":311},40.84985,-73.86641,{"facility":313,"city":314,"state":315,"zip":316,"country":135,"contacts":317,"geoPoint":320},"Cleveland Clinic","Cleveland","Ohio","44106",[318],{"name":319,"role":187},"Rishi Puri, MD",{"lat":321,"lon":322},41.4995,-81.69541,{"facility":324,"city":325,"state":315,"zip":326,"country":135,"geoPoint":327},"Riverside Methodist Hospital","Columbus","43214",{"lat":328,"lon":329},39.96118,-82.99879,{"facility":331,"city":332,"state":333,"zip":334,"country":135,"geoPoint":335},"Oregon Health","Portland","Oregon","97239",{"lat":336,"lon":337},45.52345,-122.67621,{"facility":339,"city":340,"state":341,"zip":342,"country":135,"geoPoint":343},"MUSC","Charleston","South Carolina","29425",{"lat":344,"lon":345},32.77632,-79.93275,{"facility":347,"city":348,"state":349,"zip":350,"country":135,"geoPoint":351},"Houston Methodist","Houston","Texas","77030",{"lat":352,"lon":353},29.76328,-95.36327,{"facility":355,"city":348,"state":349,"zip":350,"country":135,"geoPoint":356},"University of Texas (Memorial Hermann)",{"lat":352,"lon":353},{"facility":358,"city":359,"state":349,"zip":360,"country":135,"geoPoint":361},"Baylor Scott & White Medical","Plano","75093",{"lat":362,"lon":363},33.01984,-96.69889,{"facility":365,"city":366,"state":367,"zip":368,"country":135,"geoPoint":369},"Intermountain Heart Institute - Intermountain Medical Center","Murray","Utah","84107",{"lat":370,"lon":371},40.66689,-111.88799,{"facility":373,"city":374,"state":375,"zip":376,"country":135,"geoPoint":377},"UVA School of Medicine","Charlottesville","Virginia","22903",{"lat":378,"lon":379},38.02931,-78.47668,{"facility":381,"city":382,"state":375,"zip":383,"country":135,"geoPoint":384},"Sentara Healthcare","Norfolk","23507",{"lat":385,"lon":386},36.84681,-76.28522,{"facility":388,"city":389,"state":375,"zip":390,"country":135,"geoPoint":391},"Carilion Clinic","Roanoke","24014",{"lat":392,"lon":393},37.27097,-79.94143,[395],{"name":396,"role":184,"phone":397,"email":398},"Thuy Olender","+1 408-839-3809","tolender@productsandfeatures.com",[],[401,405],{"pmid":402,"type":403,"citation":404},"37083622","BACKGROUND","Amat-Santos IJ, Estevez-Loureiro R, Sanchez-Recalde A, Cruz-Gonzalez I, Pascual I, Mascherbauer J, Abdul-Jawad Altisent O, Nombela-Franco L, Pan M, Trillo R, Moreno R, Delle Karth G, Blasco-Turrion S, Sanchez-Luna JP, Revilla-Orodoea A, Redondo A, Zamorano JL, Puri R, Iniguez-Romo A, San Roman A. Right heart remodelling after bicaval TricValve implantation in patients with severe tricuspid regurgitation. EuroIntervention. 2023 Aug 7;19(5):e450-e452. doi: 10.4244\u002FEIJ-D-23-00077. No abstract available.",{"pmid":406,"type":407,"citation":408},"38069986","RESULT","Blasco-Turrion S, Briedis K, Estevez-Loureiro R, Sanchez-Recalde A, Cruz-Gonzalez I, Pascual I, Mascherbauer J, Abdul-Jawad Altisent O, Nombela-Franco L, Pan M, Trillo R, Moreno R, Delle Karth G, Sanchez-Luna JP, Gonzalez-Gutierrez JC, Revilla-Orodoea A, Zamorano JL, Gomez-Salvador I, Puri R, San Roman JA, Amat-Santos IJ. Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: 1-Year Follow-Up Outcomes. JACC Cardiovasc Interv. 2024 Jan 8;17(1):60-72. doi: 10.1016\u002Fj.jcin.2023.10.043. Epub 2023 Dec 6.",[410,413],{"label":411,"url":412},"Products \\& Features, manufacturer of TricValve® Transcatheter Bicaval Valve System","https:\u002F\u002Fproductsandfeatures.com\u002F",{"label":414,"url":415},"Meditrial Clinical Research Organization","http:\u002F\u002Fwww.meditrial.net",{"nct_id":4,"conditions":417,"biomarkers":418},[21,23],[],{"nct_id":4,"found":14,"summary":420,"prompt_version":430},{"design":421,"status":422,"heading":423,"summary":424,"follow_up":425,"word_count":426,"commitments":427,"compensation":428,"drugs_mentioned":429},"This is a randomized study, meaning participants are assigned by chance to receive either the TricValve System plus medical therapy or medical therapy alone. The study plans to enroll 780 participants.","completed","TricValve System for Severe Tricuspid Regurgitation","This study is testing a new device called the TricValve System for people with severe tricuspid regurgitation (a heart condition where a valve doesn't close properly, causing blood to flow backward). The study will compare the TricValve System along with standard medical care to standard medical care alone. Researchers want to see if the TricValve System can improve how well your heart works, your quality of life, and your ability to walk. They will also track any major side effects. You might be able to join if you are between 18 and 85 years old and have severe tricuspid regurgitation and caval reflux (blood flowing backward into the large veins leading to the heart). The study is currently recruiting participants.","Participants will be followed for up to 5 years after treatment to monitor their health and the effectiveness of the intervention.",120,"Participants will have follow-up visits at discharge, 1 month, 30 days, 3 months, 6 months, 12 months, and annually for up to 5 years.","Not stated in the trial record.",[35],"v2"]