[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tricuspid-valve-regurgitation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tricuspid-valve-regurgitation":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,47,70,93,112,142,173,207,228,250,275],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100551347","pivotal-trial-to-evaluate-the-safety-and-effectiveness-of-the-pf-tricvalve-transcatheter-bicaval-valve-system-100551347",false,"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).","ALL","18 Years","85 Years",{"count":21,"type":22},780,"ESTIMATED","INTERVENTIONAL",[25],"NA","Pivotal trial to evaluate the safety and effectiveness of the P\\&F TricValve® Transcatheter Bicaval Valve System.",[28,29,30,31,32,33],"Tricuspid Valve Disease","Heart Valve Diseases","Cardiovascular Diseases","Heart Failure","Tricuspid Valve Regurgitation","Tricuspid Valve Insufficiency","NOT_YET_RECRUITING","2026-05-19",{"date":37,"type":38},"2026-05-22","ACTUAL",{"date":40,"type":22},"2026-04",{"date":42,"type":22},"2032-11",{"name":44,"class":45},"P+F Products + Features USA Inc.","INDUSTRY",35,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100563085","clinical-study-of-the-inqb8-ttvr-system-the-monarq-study-100563085","NCT06611579","Clinical Study of the inQB8 TTVR System (The MonarQ Study)","A Clinical Study of the inQB8 Transcatheter Tricuspid Valve Replacement System","Inclusion Criteria:\n\n* Anatomically suitable for the MonarQ TTVR System\n* Symptomatic, tricuspid regurgitation (TR) that is severe or greater\n* Adequately treated for heart failure based upon medical standards\n* Hemodynamically stable\n\nExclusion Criteria:\n\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* Refractory Heart Failure (HF) that requires or required advanced intervention\n* Any condition, in the opinion of the investigator, making it unlikely the patient will be able to complete all protocol procedures and follow-up.\n* Currently participating in another investigational biologic, drug or device study",{"count":55,"type":22},50,[25],"Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.",[32],"RECRUITING","2026-05-14",{"date":62,"type":38},"2026-05-18",{"date":64,"type":38},"2025-06-01",{"date":66,"type":22},"2030-10-31",{"name":68,"class":45},"inQB8 Medical Technologies, LLC",8,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":69},"100560770","the-tricure-eu-pivotal-study-100560770","NCT06581471","The TRICURE EU Pivotal Study","The TRICURE EU PIVOTAL TRiCares Topaz Transcatheter TRICUspid Heart Valve REplacement System EUropean PIVOTAL Study","TRICURE EU","Inclusion Criteria:\n\n* Adult patients\n* Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)\n* Institutional Heart Team evaluates patient as being at increased operative risk\n\nExclusion Criteria:\n\n* Patient in need of emergent intervention\n* Patient who is hemodynamically unstable\n* Anatomical contraindications for implantation with study device\n* Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet",{"count":79,"type":22},80,[25],"Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System",[32,83,30],"Heart Valve Disease","2026-04-10",{"date":86,"type":38},"2026-04-15",{"date":88,"type":38},"2024-08-29",{"date":90,"type":22},"2030-12-30",{"name":92,"class":45},"TRiCares",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":81,"conditions":103,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100555042","the-tricure-efs-study-100555042","NCT06506942","The TRICURE EFS Study","The TRICURE EFS TRiCares Topaz Transfemoral TRICUspid Heart Valve REplacement System Early Feasibility Study","TRICURE EFS",{"count":101,"type":22},15,[25],[32,29,30],{"date":105,"type":38},"2026-04-14",{"date":107,"type":38},"2024-09-11",{"date":109,"type":22},"2031-03",{"name":92,"class":45},9,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":122,"briefSummary":123,"conditions":124,"keywords":129,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"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":121,"type":22},730,[25],"Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.",[32,28,125,29,33,126,127,128],"Cardiovascular Diseases (CVD)","Severe Heart Valve Disease","Randomized Controlled Trial (RCT)","Symptomatic Tricuspid Regurgitation",[130,118,131,132],"VDyne","TRIVITA Pivotal","Tricuspid Regurgitation","2026-03-31",{"date":135,"type":38},"2026-04-08",{"date":137,"type":22},"2026-06",{"date":139,"type":22},"2036-06",{"name":141,"class":45},"VDyne, Inc.",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":149,"targetDuration":151,"studyType":152,"phases":4,"briefSummary":153,"conditions":154,"keywords":158,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":172},"100619239","prospective-study-of-lead-associated-tricuspid-regurgitation-in-patients-undergoing-new-transvalvular-lead-insertion-100619239","NCT07342036","Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion","LITR","Inclusion Criteria:\n\n* medically indicated for pacemaker, ICD- or CRT implantation\n* No previous diagnosis of severe tricuspid regurgitation on enrollment\n* No existing transvalvular device (must be first implantation)\n* No other diagnosed severe valvular heart disease\n* Not previous diagnosis with pre-capillary pulmonary hypertension\n* No previous diagnosis of structural disease of the right ventricle (i.e. ACM, cardiac sarcoidosis, carcinoid...)\n\nExclusion Criteria:\n\n* Patients unable to give consent\n* Under the age of 18 years\n* Relevant pre-capillary pulmonary hypertension according to decision of the heart-team (sPAP echo \\>70 mmHg)\n* Severe tricuspid valve regurgitation (Grade 3 or worse) on enrollment\n* Patients who have undergone Lead-explantation\n* Exisiting valvular heart disease requiring treatment according to the decision of the heart-team. These patients may be enrolled in the study following treatment.\n* Previous tricuspid valve surgery\n* Patients with congenital heart disease (i.e. tetralogy of fallot, Ebstein's anomaly,...)\n* Pregnant or breastfeeding women\n* Life expectancy \\\u003C 12 months",{"count":150,"type":22},200,"1 Year","OBSERVATIONAL","The goal of this clinical trial is to record the incidence of newly developed or worsening tricuspid valve regurgitation (TR) following the implantation of a pacemaker or defibrillator with a transvenous lead. To collect this data, a transthoracic echocardiogram (TTE) with 3D imaging of the tricuspid valve (TV) will be performed before and after pacemaker implantation, with particular emphasis on assessing the tricuspid valve. Additionally, routine follow-up visits will be conducted at 6 and 12 months post-intervention, during which a TTE, ECG, NT-proBNP measurement, and pacemaker check will be performed.",[32,155,156,157],"Pacemaker","ICD","Left Bundle Branch Area Pacing",[159,160,161],"tricuspid regurgitation","lead-related TR","lead-associated TR","2026-01-14",{"date":164,"type":38},"2026-01-16",{"date":166,"type":38},"2024-07-19",{"date":168,"type":22},"2027-01-30",{"name":170,"class":171},"Hazem Omran","OTHER",1,{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":152,"phases":4,"briefSummary":183,"conditions":184,"keywords":196,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":203,"leadSponsor":205,"locationsCount":101},"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":182,"type":22},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.",[83,185,186,187,188,189,28,32,190,191,192,193,194,195],"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",[197,198],"Heart Valve Disease Progression","Heart Valve disease sequelae","2025-11-25",{"date":201,"type":38},"2025-12-05",{"date":64,"type":38},{"date":204,"type":22},"2030-05-31",{"name":206,"class":171},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":152,"phases":4,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":227},"100559858","real-world-european-investigation-of-safety-and-clinical-efficacy-of-the-evoque-system-triscend-iii-eu-100559858","NCT06569602","Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)","Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy Using a Novel Device","Inclusion Criteria:\n\n1. The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement with the EVOQUE system per the current instructions for use.\n2. Patient agrees to attend follow-up assessments.\n3. Patients provided written informed consent for participation in the study.\n\nExclusion Criteria:\n\n1. Patient participating in another interventional biologic, drug, or device clinical study that has not met its primary endpoint(s).\n2. Any patient considered to be part of a vulnerable population.",{"count":215,"type":22},500,"This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.",[32,29,30],"2024-10-29",{"date":220,"type":38},"2024-10-31",{"date":222,"type":38},"2024-10-01",{"date":224,"type":22},"2033-09-30",{"name":226,"class":45},"Edwards Lifesciences",2,{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":235,"enrollmentInfo":236,"targetDuration":238,"studyType":152,"phases":4,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":4},"100483595","tribel-registry-national-belgian-registry-of-percutaneous-tricuspid-valve-repair-using-a-transcatheter-edge-to-edge-repair-technique-100483595","NCT05577078","TriBEL Registry: National Belgian Registry of Percutaneous Tricuspid Valve Repair Using a Transcatheter Edge-to-edge Repair Technique","TriBEL","Inclusion Criteria:\n\n* At least 18 years old\n* Eligible for TEER procedure\n* Informed consent signed\n\nExclusion Criteria:\n\n* Unwilling to provide informed consent","110 Years",{"count":237,"type":22},120,"5 Years","In this study, patients who have undergone or will undergo a transcatheter edge-to-edge repair (TEER) for tricuspid valve regurgitation (TR) will be followed up for 5 years. The goal of this prospective and retrospective, observational, non-randomized, multicenter registry is to confirm that TEER is a feasible, safe and effective treatment option for TR and to evaluate the long-term efficacy and safety of TEER.\n\nThe main endpoints are:\n\n* Change in tricuspid regurgitation grade: number of patients with a reduction in tricuspid regurgitation score by at least one grade\n* Composite of major adverse event: number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia)",[32],"2022-10-10",{"date":243,"type":38},"2022-10-13",{"date":245,"type":22},"2023-01-01",{"date":247,"type":22},"2029-12-31",{"name":249,"class":171},"AZ Sint-Jan AV",{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":17,"minAge":256,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":23,"phases":259,"briefSummary":260,"conditions":261,"keywords":262,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":111},"100454198","the-travel-ii-trial-transcatheter-right-atrial-ventricular-valve-replacement-with-lux-valve-via-jugular-vein-100454198","NCT05194423","THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve Via Jugular Vein","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":258,"type":22},150,[25],"The trial aims to evaluate the safety and effectiveness of LuX-Valve transcatheter tricuspid valve and delivery system via jugular vein which are intended to use in symptomatic patients with severe tricuspid regurgitation and high surgical risk.",[32],[263,264,265],"Tricuspid valve regurgitation","Transcatheter tricuspid valve replacement","LuX-Valve","2021-12-28",{"date":268,"type":38},"2022-01-18",{"date":270,"type":22},"2022-03-01",{"date":272,"type":22},"2027-03",{"name":274,"class":171},"Changhai Hospital",{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":235,"enrollmentInfo":282,"targetDuration":238,"studyType":152,"phases":4,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":172},"100406809","the-prospecive-observational-munich-interventional-mitral-valve-registry-100406809","NCT04577248","The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry","OBSERV-MITRA","Inclusion Criteria:\n\n* Age above 18 years and consentable\n* Mitral Valve Regurgitation, Mitral Valve Stenosis, Tricuspid Valve Regurgitation, Tricuspid Stenosis\n* Transcatheter mitral or tricuspid valve therapy considered best option by heart-team decision\n* Written informed consent\n\nExclusion Criteria:\n\n* Patient's inability to fully cooperate with the protocol",{"count":283,"type":22},5000,"Prospective, single-center observational registry including all consecutive patients treated with transcatheter mitral or tricuspid valve therapy at the Deutsches Herzzentrum München, Germany.",[286,187,32],"Mitral Valve Regurgitation","2020-10-06",{"date":289,"type":38},"2020-10-08",{"date":291,"type":38},"2020-09-15",{"date":293,"type":22},"2031-01-01",{"name":295,"class":171},"Deutsches Herzzentrum Muenchen"]