[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tricuspid-valve-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tricuspid-valve-disease":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,48,82,105,133,160,188,211,247,267,292,312,335,359,380],{"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":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100327676","characteristics-and-prognosis-of-moderate-or-severe-tricuspid-regurgitation-100327676",false,"NCT03546231","Characteristics and Prognosis of Moderate or Severe Tricuspid Regurgitation","Clinical and Echocardiographic Characteristics and Prognosis of trIcuspid regurgiTation (EPIT): Prospective and Retrospective Follow-up of a Cohort of Patients With Moderate or Severe Tricuspid Regurgitation","EPIT","Inclusion Criteria:\n\n* Age \\>18 ans\n* inclusion criteria: moderate or severe tricuspid regurgitation\n* exclusion criteria: Refusal to participate\u002F prior surgery of the tricuspid valve","ALL","18 Months",{"count":20,"type":21},400,"ESTIMATED","OBSERVATIONAL","The tricuspid valve : its evaluation is relatively difficult in echocardiography and the management of tricuspid valve diseases remains poorly codified.",[25],"Tricuspid Valve Disease",[27,28,29,30,31,32,33,34],"Tricuspid regurgitation","tricuspid valve","surgery","outcome","prognosis","mortality","right ventricle","asymptomatic","RECRUITING","2026-06-12",{"date":38,"type":39},"2026-06-15","ACTUAL",{"date":41,"type":39},"2018-03-15",{"date":43,"type":21},"2026-06",{"name":45,"class":46},"Centre Hospitalier Universitaire, Amiens","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":5},"100509475","efs-of-the-duo-system-for-tricuspid-regurgitation-100509475","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","18 Years",{"count":5,"type":21},"INTERVENTIONAL",[60],"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).",[63,64,25,65],"Tricuspid Regurgitation","Tricuspid Valve Insufficiency","Heart Valve Diseases",[67,68,69,70,71],"Transcatheter","Coaptation Valve","TR","SVC","Tricuspid","2026-05-28",{"date":74,"type":39},"2026-06-01",{"date":76,"type":39},"2024-08-13",{"date":78,"type":21},"2029-10",{"name":80,"class":81},"CroiValve Limited","INDUSTRY",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":58,"phases":92,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"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":91,"type":21},1270,[60],"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",[63,64,25],"2026-05-27",{"date":97,"type":39},"2026-05-29",{"date":99,"type":39},"2019-12-11",{"date":101,"type":21},"2031-12-31",{"name":103,"class":81},"Edwards Lifesciences",79,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":58,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"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":115,"type":21},780,[60],"Pivotal trial to evaluate the safety and effectiveness of the P\\&F TricValve® Transcatheter Bicaval Valve System.",[25,65,119,120,121,64],"Cardiovascular Diseases","Heart Failure","Tricuspid Valve Regurgitation","NOT_YET_RECRUITING","2026-05-19",{"date":125,"type":39},"2026-05-22",{"date":127,"type":21},"2026-04",{"date":129,"type":21},"2032-11",{"name":131,"class":81},"P+F Products + Features USA Inc.",35,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":139,"targetDuration":141,"studyType":22,"phases":4,"briefSummary":142,"conditions":143,"keywords":149,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":4},"100635406","hummingbird-ice-study-100635406","NCT07552272","Hummingbird ICE Study","Inclusion Criteria:\n\n* 18 years of age\n* Willing to provide written, dated and signed, informed consent\n* Undergoing percutaneous cardiac intervention procedures in with VeriSight Pro is used\n\nExclusion Criteria:\n\n* Contraindicated for ICE catheter placement or considerations that make placement of VeriSight not technically feasible\n* Known contraindicated conditions include sepsis, major coagulation abnormalities, presence of any intracardiac thrombus, presence of class IV angina or heart failure, deep vein thrombosis, or significant peripheral vascular disease",{"count":140,"type":21},1000,"2 Days","The goals of this observational study are to collect data and ultrasound images using the Philips VeriSight Pro intracardiac echocardiography (ICE) catheter to assess safety and effectiveness and to support development efforts of the VeriSight Pro imaging platform.",[144,145,146,147,148,25],"ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION","Atrial Fibrillation (AF)","Valve Disease, Heart","Atrial Septal Defect","Patent Foramen Ovale",[150,151],"Intracardiac Echocardiography (ICE)","VeriSight","2026-05-18",{"date":125,"type":39},{"date":155,"type":21},"2026-07",{"date":157,"type":21},"2031-07",{"name":159,"class":81},"Philips Clinical & Medical Affairs Global",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":58,"phases":170,"briefSummary":171,"conditions":172,"keywords":177,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":184,"leadSponsor":186,"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":169,"type":21},730,[60],"Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.",[121,25,173,65,64,174,175,176],"Cardiovascular Diseases (CVD)","Severe Heart Valve Disease","Randomized Controlled Trial (RCT)","Symptomatic Tricuspid Regurgitation",[178,166,179,63],"VDyne","TRIVITA Pivotal","2026-03-31",{"date":182,"type":39},"2026-04-08",{"date":43,"type":21},{"date":185,"type":21},"2036-06",{"name":187,"class":81},"VDyne, Inc.",{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":58,"phases":198,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},"100504436","clinical-safety-and-efficacy-of-the-vdyne-transcatheter-tricuspid-valve-replacement-system-for-the-treatment-of-tricuspid-regurgitation--vista-us-100504436","NCT05848284","Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)","Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation","VISTA-US","Inclusion Criteria:\n\n* Symptomatic severe tricuspid valve regurgitation of primary or secondary etiology.\n* NYHA class ≥ II. If NYHA Class IV, patient must be ambulatory.\n* Subject is adequately treated with medical therapy for heart failure ≥ 30 days prior to\n* index procedure, including a diuretic.\n* Heart Team determines patient is a recommended candidate for the VDyne System.\n* Age \\>18 years at time of index procedure.\n* Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for treatment with the VDyne System.\n\nExclusion Criteria:\n\n* Patient anatomy (cardiac and vascular) is not suitable for VDyne System as assessed by Imaging Core Labs, Sponsor or Clinical Screening Committee (CSC)\n* Intolerance to procedural anticoagulation or post-procedural antiplatelet\u002F anticoagulation regimen that cannot be medically managed\n* Hypersensitivity to nickel or titanium\n* Left Ventricular Ejection Fraction (LVEF) \\\u003C30%.\n* Severe RV dysfunction.\n* Significant abnormalities of the tricuspid valve and sub-valvular apparatus.\n* Sepsis including active infective endocarditis (IE) (within last 6 months).\n* Right ventricular, atrial thrombus, vegetation or mass on tricuspid valve.\n* Severe tricuspid annular or leaflets calcification.\n* Systolic pulmonary hypertension with systolic pulmonary artery pressure \\>70 mmHg.\n* History or rheumatic fever\n* Significant coronary artery disease requiring treatment such as symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease.\n* Any planned surgery or interventional procedure within 30 days prior to or 30 days following the implant procedure. This includes any planned concomitant cardiovascular procedure such as CABG, PCI, pulmonary vein ablation, left atrial appendage occlusion, septal defect repair, etc.\n* Unresolved severe symptomatic carotid stenosis (\\> 70% by ultrasound).\n* Cardiac resynchronization therapy device or implantable pulse generator implanted within 60 days of planned implant procedure.\n* Permanent pacing leads that will interfere with delivery or implantation of the VDyne Valve.\n* Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure.\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* Significant valvular heart disease requiring intervention other than the tricuspid valve.\n* Known significant intracardiac shunt (e.g. septal defect)\n* Cerebrovascular accident (stroke, TIA) within 6 months 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.\n* Significant renal dysfunction (eGFR\\\u003C30 ml\u002Fmin\u002F1.73m2) or on dialysis.\n* End-stage liver disease (MELD \\> 11 \u002F CHILD class C).\n* Bleeding requiring transfusion within prior 30 days.\n* Coagulopathy or other clotting disorder that cannot be medically managed.\n* Chronic immunosuppression or other condition that could impair healing response.\n* Any of the following: leukopenia, chronic anemia (Hgb \\\u003C 9), thrombocytopenia, history of bleeding diathesis, or coagulopathy.\n* Unwilling to receive blood products.\n* Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution) which cannot be adequately managed medically.\n* Life expectancy less than 12 months due to non-cardiac comorbidities.\n* Treatment is not expected to provide benefit (futile).\n* Current IV Drug user (must be free drug abuse for \\> 1 year).\n* Pregnant, lactating or planning pregnancy within next 12 months.\n* Vulnerable patient groups (minors, cognitively impaired persons, prisoners, persons whose willingness to volunteer could be unduly influenced by the expectation of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate, such as students, residents, and employees).\n* Currently participating in an investigational drug or device trial that has not reached its primary endpoint or is likely to interfere with this study.\n* Patient (or legal guardian) unable or unwilling to provide written, informed consent before study enrollment.\n* Patient unable or unwilling to comply with study required testing and follow-up visits",{"count":197,"type":21},30,[60],"The purpose of this clinical study is to evaluate the safety and clinical efficacy of the VDyne System in the treatment of symptomatic severe tricuspid regurgitation (TR).",[63,25,201],"Tricuspid Valvular Disorders",[178],"2026-03-25",{"date":180,"type":39},{"date":206,"type":39},"2024-04-01",{"date":208,"type":21},"2031-11-30",{"name":187,"class":81},11,{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":221,"conditions":222,"keywords":235,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":5},"100613478","cohort-observing-mechanisms-progression-and-sequelae-of-valvular-heart-disease-100613478","NCT07267117","Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease","Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease (VALVE-COMPASS)","VALVE-COMPASS","Inclusion Criteria:\n\n* At least 18 years old;\n* Be willing and able to provide informed consent to participate in the study;\n* Patients with heart valve disease diagnosed by echocardiography who meet one of the following criteria:\n\n  1. Grade II or higher Aortic valve regurgitation: regurgitant jet width \\>3 mm, jet width \u002F LVOT diameter ≥25%, jet cross-sectional area\u002FLVOT cross-sectional area ≥5%, effective regurgitant orifice area (EROA) ≥0.1 cm², regurgitant volume per beat (R Vol)≥30 ml, or regurgitant fraction (RF) ≥30%.\n  2. Moderate or higher aortic valve stenosis: peak velocity ≥3.0 m\u002Fs, Mean gradient ≥20 mm Hg, aortic valve area ≤1.5 cm², Indexed aortic valve area ≤0.85 cm²\u002Fm², or velocity ratio ≤0.50.\n  3. Grade II or higher mitral valve regurgitation: regurgitant jet width ≥3 mm, regurgitant volume per beat ≥30 ml, regurgitant jet area\u002Fleft atrial area \\>30%, or effective regurgitant orifice area (EROA) ≥0.2 cm².\n  4. Moderate or higher valve stenosis: valve area (specific finding) ≤1.5 cm², or mean gradient (supportive finding) ≥10.0 mmHg.\n  5. Grade II or higher tricuspid valve regurgitation: regurgitant jet width ≥3 mm, proximal isovelocity surface area ≥6 mm, effective regurgitant orifice area (EROA) ≥0.2 cm², or regurgitant volume per beat ≥30 ml.\n  6. Significant tricuspid valve stenosis: mean pressure gradient ≥5.0 mmHg, inflow time-velocity integral \\>60 cm, T1\u002F2 ≥190 ms, or valve area ≤1.0 cm².\n  7. Grade II or higher pulmonary valve regurgitation: regurgitant jet width \\>3 mm, regurgitant volume per beat ≥30 ml, regurgitant fraction ≥30%, or effective regurgitant orifice area (EROA) ≥0.1 cm².\n  8. Moderate or higher Pulmonary valve stenosis: pulmonary valve transvalvular pressure gradient ≥40 mmHg, right ventricular systolic pressure ≥60 mmHg, or pulmonary valve opening \\\u003C1.5 cm².\n\nExclusion Criteria:\n\n* Patients who are unwilling to accept registration and follow-up;\n* Patients who cannot cooperate with information collection and follow-up due to mental illness or other conditions;\n* Patients whose life expectancy is less than 12 months due to non-cardiac diseases (such as cancer, liver disease, kidney disease, or end-stage lung disease).",{"count":220,"type":21},10000,"The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging (MRI) data. Additionally, the study aims to analyze the potential impact of device-based interventions, pharmacological therapy, and lifestyle modifications on disease progression.",[223,224,225,226,227,228,25,121,229,230,231,232,233,234],"Heart Valve Disease","Mitral Valve (MV) Regurgitation","Mitral Valve Disease","Mitral Valve Stenosis","Aortic Valve Disease","Aortic Valve Stenosis","Aortic Valve Regurgitation","Pulmonary Valve Disease","Transcatheter Valve Replacement","Transcatheter Aortic Valve Replacement (TAVR)","Transcatheter Pulmonary Valve Replacement (TPVR)","Transcatheter Edge-to-edge Repair",[236,237],"Heart Valve Disease Progression","Heart Valve disease sequelae","2025-11-25",{"date":240,"type":39},"2025-12-05",{"date":242,"type":39},"2025-06-01",{"date":244,"type":21},"2030-05-31",{"name":246,"class":46},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":193,"officialTitle":193,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":58,"phases":255,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":266},"100500535","clinical-safety-and-efficacy-of-the-vdyne-transcatheter-tricuspid-valve-replacement-system-for-the-treatment-of-tricuspid-regurgitation-100500535","NCT05797519","VISTA","Inclusion Criteria:\n\n1. Severe or greater tricuspid valve regurgitation of primary or secondary etiology.\n2. NYHA class ≥ II. If NYHA Class IV, patient must be ambulatory.\n3. Subject is adequately treated with medical therapy for heart failure \\>30 days prior to index procedure, including a diuretic.\n4. Heart Team determines patient is a recommended candidate for the VDyne System.\n5. Age 18 years or older at time of the index procedure.\n6. Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for treatment with the VDyne System.\n\nExclusion Criteria:\n\nVDYNE SYSTEM SUITABILITY\n\n1. Patient anatomy (cardiac and vascular) is not suitable for the VDyne System as assessed by Imaging Core Labs, Sponsor and\u002For Clinical Screening Committee (CSC)\n2. Intolerance to procedural anticoagulation or post-procedural antiplatelet\u002Fanticoagulation regimen that cannot be medically managed\n3. Hypersensitivity to nickel or titanium\n\n   CLINICAL EXCLUSION CRITERIA (assessed by pre-procedural imaging)\n4. Left Ventricular Ejection Fraction (LVEF) \\\u003C30%\n5. Severe RV dysfunction as assessed by the Clinical Screening Committee (CSC).\n6. Significant abnormalities of the tricuspid valve and sub-valvular apparatus\n7. Sepsis including active infective endocarditis (IE) (within the last 6 months)\n8. Right ventricular, atrial thrombus, vegetation or mass on tricuspid valve.\n9. Severe tricuspid annular or leaflets calcification\n10. Systolic pulmonary hypertension with systolic pulmonary artery pressure \\>70 mmHg or pulmonary vascular resistance (PVR) \\>5 wood units as determined by RHC.\n11. History of rheumatic fever that impacts the native tricuspid valve or surrounding structures.\n\n    CONCOMITANT PROCEDURES\n12. Significant coronary artery disease requiring treatment such as symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease (CAD).\n13. Any planned surgery or interventional procedure within 30 days prior to or following the implant procedure. This includes any planned concomitant cardiovascular procedure \\[e.g. Coronary Artery Bypass Grafting (CABG), percutaneous coronary intervention (PCI), pulmonary vein ablation, left atrial appendage occlusion, septal defect repair, etc.\\]\n14. Unresolved severe symptomatic carotid stenosis (\\> 70% by ultrasound)\n15. Cardiac resynchronization therapy device or implantable pulse generator implanted within 60 days of planned implant procedure.\n16. Permanent pacing leads that will interfere with delivery or implantation of the VDyne Valve.\n17. Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure.\n18. 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.)\n19. Significant valvular heart disease requiring intervention other than the tricuspid valve\n20. Known significant intracardiac shunt \\[e.g. septal defect), patent foramen ovales (PFOs) without significant shunts are allowed\\]\n\n    COMORBIDITIES\n21. Cerebrovascular accident (stroke, TIA) within 6 months of treatment procedure\n22. Severe lung disease \\[severe chronic obstructive pulmonary disease (COPD) or continuous use of home oxygen or oral steroids\\]\n23. Acute myocardial infarction (AMI) within 30 days\n24. Significant renal dysfunction (eGFR\\\u003C30 ml\u002Fmin\u002F1.73m2) or on dialysis\n25. End-stage liver disease (MELD \\> 11 and Child-Pugh class C)\n26. Bleeding requiring transfusion within 30 days\n27. Coagulopathy or other clotting disorder that cannot be medically managed\n28. Chronic immunosuppression or other condition that could impair healing response\n29. Any of the following: leukopenia, chronic anemia \\[Hemoglobin (Hgb) \\\u003C 9\\], current thrombocytopenia (platelets \\\u003C70), history of bleeding diathesis, or coagulopathy\n30. Unwilling to receive blood products GENERAL EXCLUSION CRITERIA\n31. Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution) which cannot be adequately managed medically\n32. Life expectancy less than 12 months due to non-cardiac comorbidities\n33. Treatment is not expected to provide benefit (futile)\n34. Current IV Drug user (must be free drug abuse for \\> 1 year)\n35. Pregnant, lactating or planning pregnancy during the course of the study\n36. Vulnerable patient groups (minors, cognitively impaired persons, prisoners, persons whose willingness to volunteer could be unduly influenced by the expectation of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate, such as students, residents, and employees)\n37. Currently participating in an investigational drug or device trial that has not reached its primary endpoint or is likely to interfere with this study\n38. Patient (or legal guardian) unable or unwilling to provide written informed consent before study-specific procedures are conducted\n39. Patient unable or unwilling to comply with study required testing and follow-up visits.",{"count":254,"type":21},120,[60],"The purpose of this clinical study is to collect safety and efficacy data of the VDyne System to support Conformitè Europëenne (CE) Mark of the VDyne System.",[63,25,201],"2025-10-30",{"date":260,"type":39},"2025-11-03",{"date":262,"type":39},"2023-03-01",{"date":264,"type":21},"2030-12-30",{"name":187,"class":81},21,{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":58,"phases":276,"briefSummary":277,"conditions":278,"keywords":279,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":291},"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":275,"type":21},92,[60],"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",[25,64],[25,280,121,281],"Tricuspid Valve Dysfunction","Tricuspid Valve Replacement","2025-08-26",{"date":284,"type":39},"2025-09-02",{"date":286,"type":39},"2022-08-10",{"date":288,"type":21},"2026-12",{"name":290,"class":81},"Corvivo Cardiovascular, Inc.",2,{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":298,"sex":17,"minAge":299,"maxAge":113,"enrollmentInfo":300,"targetDuration":4,"studyType":58,"phases":302,"briefSummary":303,"conditions":304,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":311},"100239635","cormatrix-cor-tricuspid-ecm-valve-replacement-study-100239635","NCT02397668","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. Male or female\n3. 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\n4. 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\n5. Children with congenital disease where the Cor PEDIATRIC Tricuspid ECM Valve would be the physiological right-sided 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 \\> 50mm Hg 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 \\\u003C30k). 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 \\\u003C1 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",true,"1 Year",{"count":301,"type":21},78,[60],"The Pivotal Study of the Cor TRICUSPID ECM Valve (or Cor PEDIATRIC Tricuspid ECM Valve). This study follows the EFS and is now to determine the safety and efficacy of the Cormatrix Cor TRICUSPID Valve for any patients requiring surgical replacement of the tricuspid valve.",[25],{"date":284,"type":39},{"date":307,"type":39},"2022-08-01",{"date":309,"type":21},"2026-12-15",{"name":290,"class":81},4,{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":58,"phases":322,"briefSummary":323,"conditions":324,"keywords":325,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":334},"100526673","tricvalve-bicaval-valve-system-for-severe-tricuspid-regurgitation-tricav-i-100526673","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.",{"count":321,"type":21},50,[60],"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.",[63,25],[63,120],"2025-06-04",{"date":328,"type":39},"2025-06-08",{"date":330,"type":39},"2024-07-23",{"date":332,"type":21},"2029-09",{"name":131,"class":81},36,{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":342,"enrollmentInfo":343,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":345,"conditions":346,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":47},"100561502","clinical-efficacy-and-long-term-outcomes-of-allograft-versus-stented-biological-prosthesis-for-primary-tricuspid-valve-disease-allotri-100561502","NCT06591000","Clinical Efficacy and Long-term Outcomes of ALLOgraft Versus Stented Biological Prosthesis for Primary TRIcuspid Valve Disease (ALLOTRI)","Clinical Efficacy and Long-term Outcomes of Allograft Versus Stented Biological Prosthesis for Primary Tricuspid Valve Disease","Inclusion Criteria:\n\n* Patients with primary tricuspid valve disease and\u002For tricuspid bioprosthetic failure scheduled for tricuspid valve intervention.\n\n  * Intraoperative findings suggested for tricuspid valve replacement rather than repair.\n\nExclusion Criteria:\n\n* Pregnancy\n\n  * Confirmed active drug addiction\n  * Progressive HIV-infection\n  * HIV-infected patients with CD4-cells count less than 250\n  * Patients with secondary tricuspid valve pathology (left-sided valve disease)\n  * LV Ejection fraction less than 40%","70 Years",{"count":344,"type":21},56,"The aim of the study is to evaluate early safety, clinical efficacy and long-term outcomes of mitral allografts and stented biological prosthesis in tricuspid valve replacement for primary tricuspid valve diseases.",[347,348,25],"Allograft","Bioprosthesis","2024-09-07",{"date":351,"type":39},"2024-09-19",{"date":353,"type":39},"2016-01-14",{"date":355,"type":21},"2025-06-14",{"name":357,"class":358},"Chelyabinsk Regional Clinical Hospital","OTHER_GOV",{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":58,"phases":367,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":47},"100516205","the-effects-of-360-degree-virtual-reality-on-pre-procedural-anxiety-in-patients-awaiting-elective-cardiac-surgery-involving-a-sternotomy-100516205","NCT06001489","The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy","Inclusion Criteria:\n\n* Patients awaiting elective cardiac surgery involving a sternotomy\n* 18 years or older\n\nExclusion Criteria:\n\n* Under the age of 18\n* History of previous cardiac surgery\n* (concomitant) aortic surgery\n* Cardiac surgery for congenital heart defects\n* Hearing or visual impairments\n* Language barriers (inability to understand, speak or read Dutch)\n* History of severe mental or psychiatric disorders",{"count":366,"type":21},100,[60],"Rationale: Patients awaiting cardiac surgery can experience pre-procedural anxiety. This anxiety is associated with increased analgesic needs, increased risk of mortality and prolonged recovery time. Adequate patient education can help diminish pre-procedural anxiety and minimize postoperative complications. Recent studies have demonstrated that Virtual Reality (VR) can function as a useful tool to diminish pre-procedural anxiety in several medical fields. Especially 360 degree VR could familiarize patients with their clinical pathway. Nevertheless, limited to no research on the application of 360 degree VR has been conducted in the context of cardiothoracic surgery yet.\n\nObjective: The aim of this study is to explore the effects and possible benefits of 360 degree VR on pre-procedural anxiety in patients awaiting elective cardiac surgery involving a sternotomy, compared to standard forms of patient education.\n\nStudy design: Single-center, randomized controlled trial\n\nStudy population: Patients aged 18 or older awaiting elective cardiac surgery involving a sternotomy.",[370,227,225,25],"Cardiac Valve Disease","2024-07-09",{"date":373,"type":39},"2024-07-10",{"date":375,"type":39},"2023-07-01",{"date":377,"type":21},"2024-12",{"name":379,"class":46},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":389,"conditions":390,"keywords":398,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":47},"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":388,"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.",[65,391,227,228,392,225,226,393,394,395,396,64,25,397],"Multiple Valve Disease, Unspecified","Aortic Valve Insufficiency","Mitral Valve Insufficiency and Aortic Valve Insufficiency","Mitral Valve Insufficiency","Aortic Valve Stenosis With Insufficiency","Mitral Valve Disease Mixed","Tricuspid Stenosis",[399,400],"Multiple Valvular Heart Disease","Mixed Valvular Heart Disease","2024-05-31",{"date":403,"type":39},"2024-06-03",{"date":405,"type":39},"2024-02-07",{"date":407,"type":21},"2029-08-01",{"name":409,"class":46},"Assistance Publique - Hôpitaux de Paris"]