[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tricuspid-valve-insufficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tricuspid-valve-insufficiency":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,49,72,100,129,154,179,205,236,262,283,308],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":20},"100509475","efs-of-the-duo-system-for-tricuspid-regurgitation-100509475",false,"NCT05913908","EFS of the DUO System for Tricuspid Regurgitation","Early Feasibility Study of the DUO Transcatheter Tricuspid Coaptation Valve System in Patients With Tricuspid Regurgitation","TANDEM II","Inclusion Criteria:\n\n1. Presence of severe or greater tricuspid regurgitation as determined by the Echo Core Lab.\n2. Patient is symptomatic despite medical therapy.\n3. The local Site Heart Team determines the Patient is appropriate for transcatheter valve intervention.\n4. The Patient's anatomy is suitable in the judgment of the Patient Selection Committee.\n5. Age ≥18 years\n6. The Patient has been informed of the nature of the study and agrees to its provisions and has provided written Informed Consent.\n\nExclusion Criteria:\n\n1. Patient is currently participating in another clinical investigation that could affect the outcome of this trial.\n2. Any previous tricuspid valve intervention that would interfere with the placement of the investigational device.\n3. Moderate or greater tricuspid valve stenosis.\n4. Severe aortic, mitral and\u002For pulmonic valve stenosis and\u002For regurgitation\n5. Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of the investigational device.\n6. Need for concomitant surgical or interventional procedure, known at the time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair).\n7. Ejection Fraction (EF) \\\u003C25%\n8. Echocardiographic evidence of unstable intracardiac mass, thrombus or vegetation\n9. Patient has Systolic Pulmonary Pressure (sPAP) \\>60 mm Hg\n10. Severe hemodynamic instability: cardiogenic shock or the need for inotropic support or Intra-Aortic Balloon Pump (IABP) or other percutaneous ventricular assist devices\n11. Severe respiratory instability with continuous use of home oxygen\n12. Severe right ventricular dysfunction\n13. Untreated clinically significant coronary or carotid artery disease requiring revascularization surgical or interventional PCI.\n14. Stroke or transient ischemic event within 90 days prior to the index procedure\n15. Acute myocardial infarction within 30 days before the index procedure\n16. Renal insufficiency (eGFR \\\u003C25 ml\u002Fmin) or currently on chronic dialysis\n17. Active endocarditis within 6 months of the index procedure\n18. Pulmonary embolism or deep vein thrombosis within the last 6 months\n19. Any surgical, interventional, or transcatheter procedure within 30 days prior to the index procedure\n20. Hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis\n21. Life expectancy \\\u003C1 year\n22. Active infections requiring current antibiotic therapy\n23. Known severe liver disease\n24. Is on the waiting list for a transplant or has had a prior heart or lung transplant\n25. Known active peptic ulcer or active GI bleed\n26. Unable to take anticoagulant therapy\n27. Any known major coagulation abnormalities, thrombocytopenia, platelets \\\u003C 50,000\u002Fml or severe anemia Hb \\\u003C8 g\u002Fdl\n28. Known patient is actively abusing drugs\n29. Any known sensitivities or allergies to contrast (that cannot be adequately premedicated) and\u002For the device materials, including nickel and titanium\n30. Patients who are pregnant or intend to become pregnant\n31. Any condition making it unlikely the Patient will be able to complete all protocol procedures (including compliance with optimal medical therapy and immobility that would prevent completion of 6MWT), follow-up visits, or impact the scientific soundness of the clinical investigation result","ALL","18 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"NA","The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).",[27,28,29,30],"Tricuspid Regurgitation","Tricuspid Valve Insufficiency","Tricuspid Valve Disease","Heart Valve Diseases",[32,33,34,35,36],"Transcatheter","Coaptation Valve","TR","SVC","Tricuspid","RECRUITING","2026-05-28",{"date":40,"type":41},"2026-06-01","ACTUAL",{"date":43,"type":41},"2024-08-13",{"date":45,"type":21},"2029-10",{"name":47,"class":48},"CroiValve Limited","INDUSTRY",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100369961","edwards-pascal-transcatheter-valve-repair-system-pivotal-clinical-trial-100369961","NCT04097145","Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial","A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation","CLASP II TR","Inclusion Criteria:\n\n* Eighteen (18) years of age or older\n* Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.\n* Severe or greater tricuspid regurgitation\n* New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months\n* Patient is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon with concurrence by the local Heart Team\n* Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements\n\nExclusion Criteria:\n\n* Tricuspid valve anatomy not evaluable by TTE or TEE\n* Tricuspid valve anatomy precludes proper device deployment and function\n* Patient with refractory heart failure requiring, advanced intervention (i.e. patient has or will need left ventricular assist device, or transplantation) (ACC\u002FAHA Stage D heart failure)\n* Presence of trans-tricuspid pacemaker or defibrillator leads which meet one of the following:\n\n  1. Would prevent proper TR reduction due to interaction of the lead with the leaflets\n  2. Were implanted in the RV within the last 90 days prior to the point of enrollment\n* Primary non-degenerative tricuspid disease\n* Previous tricuspid valve repair or replacement that would interfere with placement of PASCAL\n* Clinically significant, untreated coronary artery disease requiring revascularization, unstable angina, evidence of acute coronary syndrome, recent myocardial infarction\n* Significant intra-cardiac mass, thrombus, or vegetation per echo core lab assessment\n* Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 90 days\n* Recent Stroke\n* Active gastrointestinal (GI) bleeding\n* Presence of infiltrative cardiomyopathy or valvulopathy (including carcinoid, amyloidosis, sarcoidosis, hemochromatosis) or significant congenital heart disease, including but not limited to atrial septal defect, RV dysplasia, and arrhythmogenic RV\n* Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous cardiac procedure within the next 90 days\n* Any of the following cardiovascular procedures:\n\n  1. Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days prior to the point of enrollment\n  2. Carotid surgery within 30 days prior to the point of enrollment\n  3. Direct current cardioversion within the last 30 days prior to the point of enrollment\n  4. Leadless RV pacemaker implant within the last 30 days prior to the point of enrollment\n  5. Cardiac surgery within 90 days prior to the point of enrollment\n* Severe aortic, mitral and\u002For pulmonic valve stenosis and\u002For regurgitation\n* Known history of untreated severe symptomatic carotid stenosis or asymptomatic carotid stenosis\n* Active endocarditis within the last 90 days or infection requiring antibiotic therapy within the last 14 days\n* Patient is oxygen-dependent or requires continuous home oxygen\n* Pregnant, breastfeeding, or planning pregnancy within the next 12 months (365 days)\n* Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator\n* Patient is currently participating in another investigational biologic, drug, or device clinical study\n* Patient has other medical, social, or psychological conditions that preclude appropriate consent and follow-up, or the patient is under guardianship\n* Any patient considered to be vulnerable",{"count":58,"type":21},1270,[24],"To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team",[27,28,29],"2026-05-27",{"date":64,"type":41},"2026-05-29",{"date":66,"type":41},"2019-12-11",{"date":68,"type":21},"2031-12-31",{"name":70,"class":48},"Edwards Lifesciences",79,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100551347","pivotal-trial-to-evaluate-the-safety-and-effectiveness-of-the-pf-tricvalve-transcatheter-bicaval-valve-system-100551347","NCT06458907","Pivotal Trial to Evaluate the Safety and Effectiveness of the P&F TricValve® Transcatheter Bicaval Valve System","A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.","TRICAV-II","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).","85 Years",{"count":82,"type":21},780,[24],"Pivotal trial to evaluate the safety and effectiveness of the P\\&F TricValve® Transcatheter Bicaval Valve System.",[29,30,86,87,88,28],"Cardiovascular Diseases","Heart Failure","Tricuspid Valve Regurgitation","NOT_YET_RECRUITING","2026-05-19",{"date":92,"type":41},"2026-05-22",{"date":94,"type":21},"2026-04",{"date":96,"type":21},"2032-11",{"name":98,"class":48},"P+F Products + Features USA Inc.",35,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":117,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":4},"100632650","vdyne-transcatheter-tricuspid-valve-replacement-study-to-evaluate-safety-and-clinical-efficacy-in-patients-with-symptomatic-severe-tricuspid-valve-regurgitation-trivita-pivotal-trial-100632650","NCT07516444","VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)","VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation","TRIVITA","Inclusion Criteria:\n\n* Age ≥18 years old\n* Subject is willing and able to comply with all study evaluations and provide consent\n* Subject must agree not to participate in any other clinical trial for a period of one year following index procedure\n* New York Heart Association (NYHA) Functional Class II, III, or IV and ambulatory\n* At least severe symptomatic tricuspid regurgitation.\n* Despite adequate and Optimized Medical Therapy (OMT), subject has signs and symptoms from TR, or prior heart failure hospitalization from TR\n* Heart team determines that the subject is appropriate for transcatheter tricuspid valve replacement\n* Functional and\u002For degenerative TR graded as at least severe\n\nExclusion Criteria:\n\n* Subject unable or unwilling to comply with study required testing and follow-up visits\n* Subject is currently participating in another clinical trial (drug, biologic, or device) that has not yet completed its primary endpoint or is likely to interfere with this study\n* Pregnant, lactating subjects, and \u002For those who plan pregnancy in the period up to one year following index procedure.\n* Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anticoagulation, etc.) which cannot be adequately managed medically\n* Life expectancy ≤12 months due to non-cardiac comorbidities\n* Current IV Drug user (must be free from drug abuse for ≥1 year)\n* Subject unable or unwilling to provide written, informed consent before study enrollment\n* Tricuspid valve anatomy (cardiac and vascular) that is not suitable for the VDyne System\n* Hypersensitivity to metals (such as nickel or titanium)\n* Prior tricuspid valve surgery or catheter-based therapy with permanent residual device(s) implanted that would preclude delivery or implantation of the VDyne valve (e.g., valve replacement, edge to edge repair, etc.)\n* Severe valvular heart disease using established echocardiographic criteria requiring intervention other than the tricuspid valve\n* Known significant intracardiac shunt (e.g., septal defect).\n* Cerebrovascular accident (stroke, TIA) within 90 days of treatment procedure\n* Severe lung disease (severe COPD) or continuous use of home oxygen or oral steroids\n* Acute myocardial infarction (AMI) within 30 days of SSC determination of eligibility\n* Leukopenia, chronic anemia (Hgb \\\u003C 9 g\u002FdL), current thrombocytopenia (platelets \\\u003C70\u002FmcL), history of bleeding diathesis, or coagulopathy\n* Unwilling to receive blood products\n* Deep vein thrombosis and\u002For pulmonary embolism in the last 6-months",{"count":109,"type":21},730,[24],"Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.",[88,29,113,30,28,114,115,116],"Cardiovascular Diseases (CVD)","Severe Heart Valve Disease","Randomized Controlled Trial (RCT)","Symptomatic Tricuspid Regurgitation",[118,106,119,27],"VDyne","TRIVITA Pivotal","2026-03-31",{"date":122,"type":41},"2026-04-08",{"date":124,"type":21},"2026-06",{"date":126,"type":21},"2036-06",{"name":128,"class":48},"VDyne, Inc.",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":153},"100628627","evaluation-of-the-impact-of-interventional-treatments-for-symptomatic-severe-tricuspid-valve-insufficiency-on-renal-integrity-and-function-as-well-as-on-physical-function-and-activity-in-older-adults-100628627","NCT07464106","Evaluation of the Impact of Interventional Treatments for Symptomatic, Severe Tricuspid Valve Insufficiency on Renal Integrity and Function, as Well as on Physical Function and Activity in Older Adults.","TriRenGe","Inclusion Criteria:\n\n* Severe symptomatic tricuspid valve insufficiency and referral for TriClip\u002FTricValve screening\n* Completed 18th year of life\n* Ability to consent\n* Able to walk short distances with aids\n\nExclusion Criteria:\n\n* Dialysis-dependent\u002Fterminal kidney disease\n* Inability to comply with study-associated assessments (e.g., existing dementia)\n* Severe anemia (Hb \\\u003C7 g\u002Fdl)\n* Tricuspid valve intervention with palliative intent and likely imminent death\n* Lack of consent",{"count":137,"type":21},100,"OBSERVATIONAL","The hypothesis is that renal function will improve following tricuspid valve intervention. A reduction in renal biomarkers is also expected. Furthermore, based on previous assessments, it is anticipated that there will be an improvement in volume status (reduced edema), symptom burden, and physical capacity in patients. Additionally, the study will assess the impact of the intervention on functional parameters such as motor capacity, physical activity, performance of activities of daily living, and ultimately, participation and quality of life.",[27,28,141,142],"Cardio-Renal Syndrome","Frailty","2026-03-09",{"date":145,"type":41},"2026-03-11",{"date":147,"type":41},"2025-02-01",{"date":149,"type":21},"2027-12",{"name":151,"class":152},"Robert Bosch Medical Center","OTHER",1,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":164,"conditions":165,"keywords":166,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"100496336","cormatrix-cor-tricuspid-ecm-valve-replacement---pivotal-study-100496336","NCT05742906","CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study","CorMatrix® Cor™ TRICUSPID ECM® Valve Replacement Study","Inclusion Criteria:\n\n1. Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures\n2. Patient\u002Fauthorized legal guardian understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent and the pediatric patient (if applicable) provides written assent (if able) prior to procedure\n3. Patient\u002Fpatient's authorized legal guardian is geographically stable (or willing to return for required study follow-up) and understands and is willing to fulfill all of the expected requirements of this clinical protocol\n4. Patients where the Cor TRICUSPID ECM Valve will be the physiological right-sided atrioventricular (AV) valve\n\nExclusion Criteria:\n\n1. Tricuspid annulus too small (\\\u003C 10mm) to accommodate the Cor TRICUSPID ECM Valve\n2. Left ventricular ejection fraction (LVEF) \\\u003C 25%\n3. Mean pulmonary pressure ≥ 50mmHg or pulmonary vascular resistance greater than 6 Woods Units\n4. Emergency cardiac procedure. An example would be a person requiring resuscitation and in cardiogenic shock. An unscheduled or unplanned emergency surgery\n5. Cardiac transplant patient\n6. Acute transmural myocardial infarction (MI) within 7 days of enrollment that results in cardiogenic shock\n7. Patients with a single ventricle where the Cor TRICUSPID ECM Valve would be the systemic AV valve\n8. Documented primary coagulopathy or uncorrected platelet disorder, including thrombocytopenia (absolute platelet count \\\u003C 30k). Patient can be enrolled regardless of these parameters if in the opinion of the Investigating Surgeon the coagulopathy can be adequately reversed by transfusions. An example would be the reversal of thrombocytopenia by transfusion of platelets\n9. Documented evidence of intrinsic hepatic disease (defined as liver enzyme values (aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin) that are \\> 5 times the upper limit of reference range within 30 days of enrollment, except in association with acute\u002Freversible decompensation as determined by the Investigator)\n10. Documented evidence of significant renal dysfunction (serum creatinine \\> 4.0mg\u002Fdl or GFR\\\u003C 30 on the modified Schwartz formula)\n11. Stroke within 30 days prior to enrollment\n12. Major or progressive non-cardiac disease (liver failure, renal failure, cancer (CA)) that has a life expectancy of less than one year\n13. Known cancer (cancer-free ≤ 1 year; does not include non-metastatic basal cell carcinoma or cervical carcinoma) and\u002For undergoing treatment including chemotherapy and radiotherapy\n14. Hematological disorders (e.g., aplastic anemia) or patients taking bone marrow suppressant drugs\n15. Known sensitivity to porcine materials\n16. Contraindication to anticoagulation\u002Fantiplatelet therapy (aspirin (ASA) and\u002For Plavix)\n17. Patients who are pregnant (method of assessment Investigator's discretion)\n18. Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study, without CorMatrix written approval",{"count":162,"type":21},92,[24],"The goal of this pivotal study is to demonstrate the safety and performance of the Cor TRICUSPID ECM (extracellular matrix) Valve (or Cor PEDIATRIC Tricuspid ECM Valve) for the surgical management of tricuspid valve disease and dysfunction in adult and pediatric patients. The main question(s) it aims to answer are:\n\n* whether the device may be implanted successfully and safely, and\n* whether the device effectively treats tricuspid valve disease and dysfunction through 12 months\n\nParticipants will undergo:\n\n* preoperative evaluation\n* tricuspid valve replacement with the Cor TRICUSPID ECM Valve\n* postoperative evaluation, including at hospital discharge, 30 days, 6 months, and 12 months, and then annually thereafter through 5 years",[29,28],[29,167,88,168],"Tricuspid Valve Dysfunction","Tricuspid Valve Replacement","2025-08-26",{"date":171,"type":41},"2025-09-02",{"date":173,"type":41},"2022-08-10",{"date":175,"type":21},"2026-12",{"name":177,"class":48},"Corvivo Cardiovascular, Inc.",2,{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":17,"minAge":185,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":153},"100598218","korea-vhd-echo-study-surveillance-of-aortic-mitral--tricuspid-patients---insights-from-real-world-practice-100598218","NCT07068633","Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice","Inclusion Criteria:\n\n* Period: 2010.1.1\\~2020.12.31\n* Age \\> 18 years\n* Moderate or severe native VHD (AS, AR, MR and TR)\n* Perform echocardiography more than twice\n\nExclusion Criteria:\n\n* Poor image of echocardiography\n* Follow up loss","19 Years",{"count":187,"type":21},30000,"Valvular heart disease (VHD) is a growing public health concern globally, with increasing disease burden and rising interest in advanced treatment strategies such as transcatheter interventions. However, there remains a significant lack of real-world data regarding echocardiography practices, disease prevalence and progression, referral patterns, and treatment pathways. Addressing these gaps is critical for improving patient care and informing clinical decision-making.\n\nSouth Korea provides a unique opportunity to conduct a nationwide retrospective echocardiographic study due to its advanced healthcare infrastructure, high patient volume, and strong tradition in clinical research. The current study aims to evaluate the real-world burden and clinical journey of patients with moderate or severe valvular disease over a 10-year period, based on echocardiographic and electronic medical record (EMR) data collected from multiple tertiary centers across the country.",[30,190,191,192,193,28,194,195],"Aortic Valve Stenosis","Aortic Valve Insufficiency","Mitral Valve Insufficiency","Mitral Valve Prolapse","Rheumatic Heart Disease","Aortic Diseases","2025-07-07",{"date":198,"type":41},"2025-07-16",{"date":200,"type":21},"2025-08",{"date":202,"type":21},"2027-12-31",{"name":204,"class":152},"Yonsei University",{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":214,"conditions":215,"keywords":224,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":153},"100534173","european-association-of-cardiovascular-imaging-multiple-and-mixed-valvular-disease-study-100534173","NCT06235385","European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study","EACVI-MMVD","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patient referred to the cardiovascular imaging department.\n3. Diagnosis of MMVD confirmed by transthoracic echocardiography, defined as:\n\n   1. Multiple VHD: at least 2 moderates to severe VHD involving ≥ 2 different valves, using the current ESC guidelines.\n\n      and\u002For\n   2. Mixed VHD: at least moderate stenosis and at least moderate regurgitation of a single valve, using the current ESC guidelines.\n4. Patient not refusing to have their data involved in the protocol after information.\n\nExclusion Criteria (patients fulfilling any of the following criteria are not eligible for inclusion in this study):\n\n1. History of prior valve surgery or percutaneous valve intervention (concerning a valve other than those involved in the definition of MMVD).\n2. Acute infective endocarditis at the time of evaluation for inclusion (confirmed according to modified Duke criteria) or history of endocarditis ≤ 6 months.\n3. Complex congenital heart diseases.",{"count":213,"type":21},1500,"This study aims to investigate the prevalence and characteristics of multiple and mixed valvular heart disease (MMVD), which includes combinations of stenotic or regurgitant lesions on cardiac valves. The research will be conducted as a multicenter observational study, involving several centers worldwide, and will have a one-year follow-up period (with a possible extension to 5 years). The primary aim is to determine the proportion of MMVD among patients evaluated for valvular heart disease. Secondary aims include the evaluation of the epidemiologic distribution of clinical, biological, and cardiovascular imaging characteristics at baseline, management strategies, and their impact on prognosis. The study will also evaluate clinical outcomes such as mortality, hospitalization for heart failure, and changes in echocardiographic parameters. This research aims to provide valuable insights into the diagnosis, management, and prognosis of MMVD, addressing an important knowledge gap in this area.",[30,216,217,190,191,218,219,220,192,221,222,28,29,223],"Multiple Valve Disease, Unspecified","Aortic Valve Disease","Mitral Valve Disease","Mitral Valve Stenosis","Mitral Valve Insufficiency and Aortic Valve Insufficiency","Aortic Valve Stenosis With Insufficiency","Mitral Valve Disease Mixed","Tricuspid Stenosis",[225,226],"Multiple Valvular Heart Disease","Mixed Valvular Heart Disease","2024-05-31",{"date":229,"type":41},"2024-06-03",{"date":231,"type":41},"2024-02-07",{"date":233,"type":21},"2029-08-01",{"name":235,"class":152},"Assistance Publique - Hôpitaux de Paris",{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":243,"targetDuration":245,"studyType":138,"phases":4,"briefSummary":246,"conditions":247,"keywords":250,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":261},"100448084","retrospective-prospective-multicentric-clinical-follow-up-of-patients-after-being-treated-with-tricvalve-100448084","NCT05114850","Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve®","TRICUS REGISTRY - Retrospective Prospective Multicentric Clinical Follow up of Patients With Severe Tricuspid Regurgitation After Being Treated With the TricValve® Transcatheter Bicaval Valves System.","Inclusion Criteria:\n\n* Successful treatment with TricValve Transcatheter Bicaval Valves System\n* Patient\u002Fpatient's authorized legal guardian gives his consent to participate in the study and signed the corresponding inform consent\n\nExclusion Criteria:\n\n* no exclusion criterion",{"count":244,"type":21},450,"5 Years","Retrospective prospective Multicentric clinical follow up of patients with severe tricuspid regurgitation after being treated with the TricValve® Transcatheter Bicaval Valves System.",[27,28,248,87,249,30],"Tricuspid Insufficiency","Heart Diseases",[251],"Cardiovascular disease","2024-04-02",{"date":254,"type":41},"2024-04-03",{"date":256,"type":41},"2022-04-20",{"date":258,"type":21},"2028-12",{"name":260,"class":48},"P+F Products + Features GmbH",28,{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":270,"enrollmentInfo":271,"targetDuration":245,"studyType":138,"phases":4,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":279,"leadSponsor":281,"locationsCount":153},"100418921","transcatheter-interventions-for-tricuspid-insufficiency-in-italy-100418921","NCT04735003","Transcatheter Interventions for Tricuspid Insufficiency in Italy","TRans-catheter Interventions for triCuspid Valve Insufficiency: the iTalian Multicentre Study","TRIC-IT","Inclusion Criteria:\n\n1. Patients undergoing transcatheter treatment of tricuspid regurgitation (native valve -with or without previous surgical valve repair - or degenerated bioprosthesis)\n2. Patients who are willing and capable of providing informed consent, and participating in all follow-ups associated with this clinical investigation.\n\nExclusion Criteria:\n\n1. Valve anatomy unsuitable for transcatheter tricuspid valve interventions.\n2. Subjects who are unable or not willing to complete follow-up visits and examination for the duration of the study.","100 Years",{"count":272,"type":21},200,"This is an observational, multi-center, retrospective and prospective study collecting data about patients undergoing transcatheter tricuspid valve interventions in a real world clinical environment. The aim is to report clinical characteristics, procedural results and short- and long-term outcomes of patients undergoing transcatheter tricuspid valve interventions in Italian centres.",[28],"2021-01-30",{"date":277,"type":41},"2021-02-02",{"date":275,"type":21},{"date":280,"type":21},"2027-01-30",{"name":282,"class":152},"Marianna Adamo",{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":289,"targetDuration":245,"studyType":138,"phases":4,"briefSummary":291,"conditions":292,"keywords":294,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":153},"100412659","german-registry-for-transcatheter-tricuspid-valve-interventions-100412659","NCT04653428","German Registry for Transcatheter Tricuspid Valve Interventions","Inclusion Criteria:\n\n* Interventional treatment of severe tricuspid regurgitation (isolated or in combination with another interventional treatment) with a CE certified product for tricuspid valve repair\n* Informed consent corresponding to criteria of Good Clinical Practice and the decleration of Helsinki as well as to standards of the local ethic commission.\n\nExclusion Criteria:\n\n* No agreement to participation\n* Age \\\u003C 18 years",{"count":290,"type":21},600,"Multicentre observational study of patients with severe tricuspid regurgitation and interventional treatment.",[27,28,293],"Heart Valve",[295,296,297,298],"Tricuspid regurgiation","Tricuspid valve insufficiency","Interventional treatment","Heart valve diseases","2020-11-28",{"date":301,"type":41},"2020-12-04",{"date":303,"type":41},"2020-10-01",{"date":305,"type":21},"2030-12-31",{"name":307,"class":152},"LMU Klinikum",{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":17,"minAge":315,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":22,"phases":318,"briefSummary":319,"conditions":320,"keywords":321,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":330,"locationsCount":332},"100396019","the-travel-trial-transcatheter-right-atrial-ventricular-valve-replacement-with-lux-valve-100396019","NCT04436653","THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve","TRAVEL","Inclusion Criteria:\n\n1. Age ≥ 50 years at time of consent.\n2. Subjects or subject's legal representative has been informed of the nature of the study and provided written informed consent.\n3. The site heart team confirmed the subject is at high risk for tricuspid valve surgery (euroSCORE II ≥ 7.0%) and the subject will get benefit from the intervention.\n4. Subjects must guarantee they won't participate in any other clinical trial for a period of one year after the intervention.\n5. Subjects are with New York Heart Association (NYHA) Functional Class III or IV.\n6. Subjects are with normal left heart function (EF ≥ 50%).\n7. No indications for left-sided or pulmonary valve intervention.\n8. Subjects must have severe or greater tricuspid regurgitation ( the vena contracta (VC) width ≥ 7 mm or the effective regurgitant orifice area (EROA) ≥ 40 mm2), which confirmed by the Echocardiography Core Lab (ECL) via transthoracic echocardiogram (TTE).\n\nExclusion Criteria:\n\n1. Subjects with pulmonary hypertension (systolic pressure ≥ 55mmHg determined by right heart catheterization).\n2. Subjects with previous transcatheter or surgical tricuspid valve procedure.\n3. Subjects with tricuspid stenosis or other anatomy disorders that unsuitable for the procedure.\n4. Subjects with depressed right heart function (tricuspid annular plane systolic excursion (TAPSE) \\\u003C 10mm or right ventricle fractional area change (FAC) \\\u003C 20%).\n5. Subjects with aortic stenosis (mean ΔP≥ 40mmHg or aortic valve area ≤ 1 cm2), aortic regurgitation (≥ 3+), mitral stenosis (mitral valve area ≤1.5 cm2) or mitral regurgitation (≥ 3+).\n6. Subjects with active endocarditis or other infectious diseases.\n7. Subjects with untreated severe coronary artery disease.\n8. Subjects with percutaneous coronary intervention, cerebrovascular accident or surgical intervention within 3 months of the date of the procedure.\n9. Subjects with coagulation disorders.\n10. Subjects with known allergy, hypersensitivity or contraindication to the material or drugs used in the procedure.\n11. Subjects with cognitive disorders that can not cooperate the study or follow-up.\n12. Subjects with less than 12 months life expectancy because of non-cardiac conditions.","50 Years",{"count":317,"type":21},150,[24],"The trial aims to evaluate the safety and effectiveness of LuX-Valve transcatheter tricuspid valve and delivery system which are intended to use in symptomatic patients with severe tricuspid regurgitation and high surgical risk.",[28],[27,322,323],"LuX-Valve","Transcatheter Valve Replacement","2020-11-16",{"date":326,"type":41},"2020-11-17",{"date":328,"type":41},"2020-06-16",{"date":124,"type":21},{"name":331,"class":152},"Changhai Hospital",8]