[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tricuspid-regurgitation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tricuspid-regurgitation":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,48,0,25,[9,41,63,94,126,156,179,202,233,254,276,301,323,345,366,386,415,439,466,487,507,529,553,573,596],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100395743","ttvr-early-feasibility-study-100395743",false,"NCT04433065","TTVR Early Feasibility Study","The Early Feasibility Study of the Transcatheter Tricuspid Valve Replacement System Transfemoral System","Inclusion Criteria:\n\n* Heart Team agrees that patient is deemed symptomatic despite medical therapy (including obligatory diuretic) and a candidate for bioprosthetic tricuspid valve replacement\n* Subject is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the local Heart Team\n* Subjects with severe symptomatic primary and \u002F or secondary tricuspid regurgitation determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE)\n* New York Heart Association (NYHA) Function Class II or greater\n* Subject anatomically suitable for the Intrepid TTVR delivery system including transfemoral access\n* Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits\n* Subject meets the legal minimum age to provide informed consent based on local regulatory requirements\n\nExclusion Criteria:\n\n* Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions\n* Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions)\n* Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus\n* Implanted with venous stents (iliac and\u002For femoral) or inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access of delivery system\n* Echocardiographic evidence of severe right ventricular dysfunction\n* Left ventricular ejection fraction (LVEF) \\\u003C30 as measured by resting echocardiogram within 30 days of the Index Procedure\n* Need for emergent or urgent surgery\n* Untreated clinically significant coronary artery disease requiring revascularization\n* Carcinoid tricuspid regurgitation","ALL","18 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"NA","The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.",[27],"Tricuspid Regurgitation","RECRUITING","2026-06-26",{"date":31,"type":32},"2026-06-29","ACTUAL",{"date":34,"type":32},"2020-10-20",{"date":36,"type":21},"2031-07-30",{"name":38,"class":39},"Medtronic Cardiovascular","INDUSTRY",20,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":62},"100482010","safety-and-effectiveness-study-of-dragonfly-t-system-for-severe-tricuspid-regurgitation-100482010","NCT05556460","Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation","A Prospective, Multicenter, Parallel, Randomized Controlled Study to Evaluate the Safety and Effectiveness of the DragonFly-T Transcatheter Tricuspid Valve Clip System in the Treatment of Tricuspid Regurgitation","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. In the judgment of the local cardiac team, the patient has been adequately treated according to applicable standards (including medical management)and has been stable for at least 30 days.\n3. Despite the drug optimization treatment according to the above method, patients still have symptoms of TR;\n4. Determined by the local cardiac team to be at intermediate or higher risk for tricuspid valve surgery\n5. New York Heart Association (NYHA) Cardiac function Class II-IVa;\n\n5\\. The patient is suitable for transcatheter tricuspid valve repair, suitable for the use of this study instrument, and the femoral vein access is feasible and can accommodate catheter; 6. Patient must provide written informed consent before any steps related to the study.\n\nExclusion Criteria:\n\n1. Tricuspid valve leaflet anatomy, which may preclude clip implantation, proper clip positioning on the leaflets, including but not limited to the following:\n\n   1. Evidence of calcification in the grasping area;\n   2. Presence of a severe coaptation defect of the tricuspid leaflets;\n   3. Severe leaflet defect(s) and cleft preventing proper device placement determined by ECL;\n   4. Epstein anomaly.\n2. Other serious heart valvular diseases requiring intervention or planning to intervention in the next 12 months; Note: If mitral and tricuspid valve lesions are combined, mitral valve surgery can be performed first, and re-evaluation can be performed 60 days after surgery.\n3. Tricuspid stenosis evaluated by ECL and\u002For cross-tricuspid differential pressure ≥ 5 mmHg;\n4. Previous tricuspid valve surgery or transcatheter therapy;\n5. Echocardiography suggested intracardiac thrombus, tumor or mass, or femoral vein and inferior vena cava implants or thrombus;\n6. TTE and TEE are unable to evaluate tricuspid valve anatomy; Participated in any drug and\u002For medical device clinical trials within 1 month prior to the trial; ……\n\n28\\. The researchers do not consider it appropriate to be enrolled in the study.",{"count":49,"type":21},236,[24],"The primary objective of this trial is to demonstrate the safety and effectiveness of the DragonFly-T system in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (DragonFly-T system) to Control (Medical Therapy).",[27],"2026-06-10",{"date":55,"type":32},"2026-06-12",{"date":57,"type":32},"2024-09-03",{"date":59,"type":21},"2032-08-15",{"name":61,"class":39},"Hangzhou Valgen Medtech Co., Ltd",2,{"id":64,"slug":65,"hasResults":12,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":72,"phases":4,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":4},"100634071","comparing-the-effects-of-newer-pacemakers-and-their-effects-on-the-heart-and-valve-function-in-the-short-term-100634071","NCT07534917","Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.","Left Bundle Branch Area Pacing Versus Right Ventricular Leadless Pacing: Acute Effects on Biventricular and Tricuspid Valve Function","LvL-PACE","Inclusion Criteria:\n\n* All patients aged ≥18 referred for a permanent pacemaker at a single centre (Guys and St. Thomas' NHS Foundation Trust, UK) with high degree AV block, including Mobitz II and complete heart block, or scheduled AV node ablation, and LVEF ≥50%.\n\nExclusion Criteria:\n\n* LVEF \\\u003C50%, severe TR, severe RV dysfunction, clinically unstable AV block requiring temporary pacing or isoprenaline infusion, left bundle branch block, previous TV annuloplasty or replacement, aortic valve replacement, life expectancy \\\u003C1 year, end-stage renal failure, contraindication to cardiac MRI, CT or TOE, pregnancy, contraindication to anticoagulation, peripheral vascular disease precluding insertion of femoral catheters and insufficient capacity to consent to the study.",{"count":40,"type":21},"OBSERVATIONAL","Conventional pacemakers involve placing a lead through a valve into the bottom right chamber of the heart. Research has shown that this approach is associated with an increased risk of valve dysfunction, mortality, and impairment of cardiac function.\n\nNewer pacemakers, such as leadless pacemakers and pacemakers that engage directly with the heart's native conduction system (known as left bundle branch pacemakers), are increasingly being adopted. However, the impact of these newer pacing technologies on cardiac function and the tricuspid valve, as well as how they compare with each other, remains unclear.\n\nThe investigators aim to study the impact of leadless pacemakers and left bundle branch pacemakers on cardiac function and the tricuspid valve by conducting an acute study in addition to the routine pacemaker implantation procedure for which participants have been referred. Both procedures will be performed during a single session under general anaesthesia. Outcomes from this study will improve understanding of how these pacing technologies affect cardiac and valvular function and how they compare with each other. These findings will help guide decision-making regarding the optimal type of pacemaker to adopt, particularly for patients at greatest risk of developing tricuspid valve dysfunction or impaired cardiac function.",[75,27,76],"Pacemaker-Induced Cardiomyopathy","Right Ventricular Dysfunction",[78,79,80,81,82],"leadless pacemaker","left bundle branch area pacing","pacemaker-induced cardiomyopathy","tricuspid regurgitation","right ventricular dysfunction","NOT_YET_RECRUITING","2026-06-04",{"date":86,"type":32},"2026-06-08",{"date":88,"type":21},"2026-07-01",{"date":90,"type":21},"2029-06-01",{"name":92,"class":93},"Guy's and St Thomas' NHS Foundation Trust","OTHER",{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":72,"phases":4,"briefSummary":104,"conditions":105,"keywords":109,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100640284","evaluation-of-a-management-algorithm-for-tavi-patients-with-concomitant-mitral-or-tricuspid-regurgitation-100640284","NCT07623083","Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation","Evaluation of a Treatment Algorithm for the Management of TAVI Patients With Significant Concomitant Mitral or Tricuspid Regurgitation","MASTER-TAVI II","Inclusion Criteria:\n\n* Age \\>18 years.\n* Patients with severe AS undergoing transarterial TAVI.\n* Concomitant significant MR and\u002For TR (≥3+).\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C1 year due to noncardiac conditions.\n* Any prior mitral or tricuspid valve surgery.\n* Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.\n* Active endocarditis.\n* Subjects in whom transesophageal echocardiography is contraindicated or high risk.",{"count":103,"type":21},300,"Aortic stenosis is a condition in which the aortic valve becomes narrow and does not open properly, making it harder for the heart to pump blood to the body. Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure commonly used to treat this condition, especially in older patients or patients at high surgical risk.\n\nMany patients undergoing TAVI also have leakage of the mitral valve and\u002For tricuspid valve. These valve problems can cause symptoms such as shortness of breath, fatigue, swelling, heart failure, and repeated hospitalizations. Patients with multiple valve diseases generally have worse outcomes and are more difficult to treat.\n\nIn some patients, mitral or tricuspid valve leakage improves after TAVI because the heart works better once the aortic valve has been treated. However, in other patients, the leakage remains severe and continues to affect their health and quality of life. New minimally invasive treatments are now available to repair or replace the mitral and tricuspid valves, but doctors still do not know the best order or timing for these procedures.\n\nThis study aims to evaluate a treatment algorithm for patients with severe aortic stenosis and significant mitral and\u002For tricuspid valve leakage. The proposed approach follows current clinical guidelines and uses a stepwise strategy. Patients will first undergo TAVI, followed by reassessment of the mitral and tricuspid valves. If important valve leakage persists after TAVI, additional minimally invasive procedures may be considered to treat the mitral or tricuspid valve.\n\nThe study will include patients with severe aortic stenosis and moderate-to-severe or severe mitral and\u002For tricuspid regurgitation. Researchers will collect information about patient symptoms, heart imaging results, procedures, hospitalizations, quality of life, and clinical outcomes during follow-up.\n\nThe main goal of the study is to evaluate whether this staged treatment approach is safe, feasible, and effective in improving patient outcomes. Researchers will also assess whether the strategy can reduce hospitalizations for heart failure and improve symptoms, daily functioning, and quality of life.\n\nThe results of this study may help doctors better manage patients with multiple valve diseases and provide a more personalized and structured treatment approach for this complex group of patients.",[106,107,27,108],"Aortic Stenosis","Mitral Regurgitation","Transcatheter Aortic Valve Implantation (TAVI)",[110,111,112,113,114,115,116],"Aortic stenosis","Transcatheter aortic valve implantation (TAVI)","Multivalvular heart disease","Mitral regurgitation","Tricuspid regurgitation","Structural heart disease","Valve disease management algorithm","2026-05-28",{"date":119,"type":32},"2026-06-03",{"date":121,"type":21},"2026-06-05",{"date":123,"type":21},"2034-06-05",{"name":125,"class":93},"Josep Rodes-Cabau",{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":142,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":135},"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",{"count":135,"type":21},15,[24],"The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).",[27,139,140,141],"Tricuspid Valve Insufficiency","Tricuspid Valve Disease","Heart Valve Diseases",[143,144,145,146,147],"Transcatheter","Coaptation Valve","TR","SVC","Tricuspid",{"date":149,"type":32},"2026-06-01",{"date":151,"type":32},"2024-08-13",{"date":153,"type":21},"2029-10",{"name":155,"class":39},"CroiValve Limited",{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"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":165,"type":21},1270,[24],"To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team",[27,139,140],"2026-05-27",{"date":171,"type":32},"2026-05-29",{"date":173,"type":32},"2019-12-11",{"date":175,"type":21},"2031-12-31",{"name":177,"class":39},"Edwards Lifesciences",79,{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":186,"targetDuration":188,"studyType":72,"phases":4,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":201},"100638048","active-post-market-surveillance-of-innovative-devices-for-valvular-heart-disease-100638048","NCT07605624","Active Post-Market Surveillance of Innovative Devices for Valvular Heart Disease","An Active Post-Market Surveillance Study Assessing the Real-World Clinical Applicability, Long-Term Safety, and Effectiveness of Innovative Medical Devices for Valvular Heart Disease","Inclusion Criteria:\n\n* Patients with valvular heart disease (VHD) receiving treatment with prosthetic aortic valve replacement systems (transcatheter and surgical valves), transcatheter mitral valve edge-to-edge repair (TEER) systems, or transcatheter tricuspid valve annuloplasty systems\n* Age ≥ 18 years\n* Patients who voluntarily participate in the study and sign the informed consent form\n* Willing and able to comply with follow-up requirements",{"count":187,"type":21},5500,"1 Year","This prospective, multicenter, observational cohort study aims to establish a post-market registry framework to evaluate the real-world clinical applicability, long-term safety, and effectiveness of innovative heart valve devices in China.",[106,191,107,27],"Aortic Regurgitation","2026-05-18",{"date":194,"type":32},"2026-05-26",{"date":196,"type":21},"2026-05-10",{"date":198,"type":21},"2029-01-31",{"name":200,"class":93},"Beijing Anzhen Hospital",1,{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":72,"phases":4,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":232},"100420927","annuloplasty-rings-and-band-post-market-clinical-follow-up-study-100420927","NCT04761120","Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study","Annuloplasty Rings and Band Post-Market Clinical Follow-Up (ARB-PMCF) Study","ARB-PMCF","Inclusion Criteria:\n\n1. Subject is expected to undergo cardiac surgery in ≤90 days including at least one of the following:\n\n   1. implant of a Rigid Saddle Ring, Séguin Ring or a full Tailor Ring without cut zone removal for MR repair\n   2. implant of a full Tailor Ring without cut zone removal for TR repair, or\n   3. implant of a Tailor Band or partial Tailor Ring with cut zone removed for primary TR repair.\n2. Subject's cardiac surgery will be performed by a study investigator.\n3. Subject will be ≥18 years old at the time of their annuloplasty implant(s).\n4. Subject provides written informed consent and agrees to comply with all required study visits and procedures.\n\nExclusion Criteria:\n\n1. Subject is below the age of legal consent in the applicable jurisdiction or otherwise lacks legal authority to provide informed consent.\n2. Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent.\n3. Subject is expected to have active endocarditis at the time of their Abbott annuloplasty device implant(s).\n4. Subject cannot be unambiguously assigned to a treatment group due to missing data on repair indication(s) or the model and configuration (cut zone removed or not) of their Abbott annuloplasty implant(s).\n5. Subject is participating in another clinical investigation including any treatment outside the investigative site's usual standard of care.\n6. Subject has anomalous anatomy or medical, surgical, psychiatric or social history or conditions that, in the investigator's opinion, would limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements",{"count":211,"type":21},550,"ARB-PMCF is a multicenter, observational study of the safety and performance of Abbott annuloplasty devices used in surgical repair of mitral and tricuspid valve regurgitation. The devices included in this study are the SJM™ Rigid Saddle Ring and SJM Séguin Annuloplasty Ring, indicated for mitral valve repair, and the SJM Tailor™ Annuloplasty Ring and SJM Tailor Annuloplasty Band, indicated for mitral or tricuspid repair. Participants will be enrolled prior to undergoing mitral or tricuspid valve repair surgery including an Abbott annuloplasty implant and will complete annual follow-up visits through five years from implant. The study is being conducted to meet post-market clinical follow-up requirements of the European Union Medical Device Directives.",[107,27,214],"Valvular Heart Disease",[107,27,216,217,218,219,220,221,222,223],"Valve Surgery","Valve Repair","Annuloplasty Rings","Annuloplasty Bands","Rigid Saddle Ring","Séguin Annuloplasty Ring","Tailor Annuloplasty Ring","Tailor Annuloplasty Band","2026-05-14",{"date":192,"type":32},{"date":227,"type":32},"2021-02-01",{"date":229,"type":21},"2031-03",{"name":231,"class":39},"Abbott Medical Devices",17,{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":201},"100618674","target-20-study-safety-and-performance-of-the-cardiovalve-tr-replacement-system-100618674","NCT07334691","TARGET 2.0 Study: Safety and Performance of the Cardiovalve TR Replacement System","TARGET 2.0 Study: Safety and Performance of the Cardiovalve Tricuspid Valve Replacement System in the Treatment of Subjects With Tricuspid Regurgitation- Investigation","Inclusion Criteria:\n\n1. Subject is ≥ 18 and \\\u003C85 years\n2. Severe tricuspid regurgitation (TR) ≥3+ based upon echocardiography, as assessed by independent core laboratory using a 5-grade classification (mild (1), moderate (2), severe (3), massive (4), torrential (5)). Trace and no TR is considered 0)29\n3. Symptomatic, NYHA Class II-IV\n4. Left ventricular ejection fraction (LVEF) ≥ 30%\n5. Subject adequately treated based upon medical standards\n6. Subjects are at high risk for open heart surgery\n7. Subject provided written, informed consent before investigation enrollment\n8. Subject approved by the Subject Screening Committee\n\n   Anatomical Inclusion Criteria (measured by CT)\n9. Right femoral vein diameter \\> 9mm\n10. Tricuspid valve diameter \\\u003C 55 mm\n11. RV length \\> 45 mm\n\nExclusion Criteria:\n\nSubjects will be excluded from the investigation if fulfill any of the following criteria:\n\n1. Cardiac anatomy deemed not suitable for the Cardiovalve TR system as evaluated (by CT)\n2. Venous peripheral anatomy or any spinal anatomy that is unsuitable for Cardiovalve TR implant delivery (by CT)\n3. Primary tricuspid disease that may interfere with Cardiovalve implantation\n4. Severe right ventricular failure (by Echo core lab adjudication)\n5. Significant coronary artery disease requiring percutaneous or surgical intervention\n6. Severe systolic pulmonary arterial pressure, pASP \\> 2\u002F3 systemic BP with PVR \\> 5 Wood units after vasodilator challenge\n7. Presence of any known life threatening non-cardiac disease that will limit the subject's life expectancy to less than one year\n8. Cerebrovascular event (stroke, TIA) within the past 3 months\n9. Active endocarditis or history of mitral\u002Ftricuspid endocarditis within 3 months or infection requiring antibiotic within 2 weeks before index procedure\n10. Subject has significant other sided valvular heart disease which requires treatment (e.g. mitral regurgitation or stenosis, or aortic regurgitation or stenosis)\n11. Documented primary coagulopathy or platelet disorder, including thrombocytopenia (absolute platelet count \\\u003C90k)\n12. Documented evidence of significant renal dysfunction (eGFR\\\u003C30 ml\u002Fmin\u002F1.73m2) or any form of dialysis at time of screening within 30 days\n13. Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, contrast media, or Polyethylene Glycol (PEG)\n14. Subjects unsuitable for implantation due to thrombosis of the lower venous system or presence of a vena cava filter\n15. Evidence of an acute myocardial infarction (AMI) ≤ 1 month (30 days)\n16. Liver cirrhosis \\> Child-Pugh Class A\n17. Psychiatric or behavioral disease including known alcohol or drug abuser that is likely to impair compliance with protocol\n18. Pregnant, lactating or planning pregnancy within next 12 months\n19. Requirement for antibiotic treatment within the last 48 hours\n20. Surgical or interventional procedure planned within 30 days prior to index procedure\n21. Refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) or UNOS Status 1 heart transplant or prior orthotropic heart transplantation.\n22. Prior Tricuspid valve surgery or transcatheter tricuspid valve procedure that may interfere with the Cardiovalve device. Valve in a valve procedure is excluded.\n23. Modified Rankin Scale \\> 4 disability\n24. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within 30 days prior to index procedure\n25. Acutely decompensated heart failure (i.e. hemodynamically unstable or requiring IV inotrope) at the time of screening\n26. Severe COPD or continuous use of home oxygen\n27. Hgb \\\u003C 9 g\u002FdL at screening\n28. The subject has contraindication against a transesophageal echo (TEE) during the procedure that cannot be replaced by other imaging.\n29. Currently participating in an investigational drug or another device investigation which has not reached its primary endpoint\n30. Subjects with \\>2 leads or with any lead that may interfere with Cardiovalve procedure or device","85 Years",{"count":20,"type":21},[24],"This investigation is a continuation for \"TARGET\" investigation and its purpose is to further demonstrate the efficiency and safety of the Cardiovalve system in the treatment of subjects with tricuspid regurgitation. The same subject population will be included, while applying the clinical and scientific knowledge accumulated in the TARGET investigation. This investigation will support the submission for obtaining marketing approval.",[27],"2026-05-06",{"date":247,"type":32},"2026-05-11",{"date":249,"type":32},"2026-01-20",{"date":251,"type":21},"2033-09",{"name":253,"class":39},"Cardiovalve Ltd.",{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":72,"phases":4,"briefSummary":264,"conditions":265,"keywords":266,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":201},"100632128","triclip-japan-post-approval-study-100632128","NCT07509658","TriClip Japan Post-Approval Study","A Prospective, Single-arm, Multi-center, Observational, Post-approval Study Designed to Confirm the Safety and Efficacy of the TriClip System in Japan.","TriClip JP PAS","Inclusion Criteria:\n\n* Subjects are eligible to receive the TriClip System per the current approved indications for use (IFU)\n* Subjects provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.\n\nExclusion Criteria:\n\n* There are no exclusion criteria\n* Please note: It is not recommended that subjects enrolled in the study participate in any other therapeutic clinical study.",{"count":263,"type":21},250,"The goal of this observational post approval study is to confirm the safety and efficacy of the TriClip System when used in routine clinical practice in the Japanese population and to fulfill post-market requirements following commercial approval in Japan.",[27],[145,27,267],"TriClip","2026-03-31",{"date":270,"type":32},"2026-04-03",{"date":272,"type":32},"2026-03-02",{"date":274,"type":21},"2029-12-15",{"name":231,"class":39},{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":22,"phases":286,"briefSummary":287,"conditions":288,"keywords":290,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":300},"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":285,"type":21},30,[24],"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).",[27,140,289],"Tricuspid Valvular Disorders",[291],"VDyne","2026-03-25",{"date":268,"type":32},{"date":295,"type":32},"2024-04-01",{"date":297,"type":21},"2031-11-30",{"name":299,"class":39},"VDyne, Inc.",11,{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":307,"enrollmentInfo":308,"targetDuration":310,"studyType":72,"phases":4,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":201},"100406265","berlin-registry-of-right-heart-interventions-100406265","NCT04570163","Berlin Registry of Right Heart Interventions","Inclusion Criteria:\n\n* Patients with planned or recent valve interventions of the right heart (tricuspid regurgitation\u002F stenosis, pulmonary regurgitation\u002F stenosis)\n* \\>18 years\n* Written, documented consent\n\nExclusion Criteria:\n\n* Patients in care or unable to consent\n* Patients who are unable to comply with follow-up examinations\n* Patients who are detained in an institution","120 Years",{"count":309,"type":21},200,"24 Months","The present study evaluates patients after interventional therapy of valvular diseases of the right heart. Follow-up examinations include medical history taking, laboratory measurements and an echo. The aim is to assess the different interventional therapies and their impact on patient's outcome.",[27,313],"Pulmonary Regurgitation","2026-03-18",{"date":316,"type":32},"2026-03-19",{"date":318,"type":32},"2020-06-16",{"date":320,"type":21},"2035-12-31",{"name":322,"class":93},"Charite University, Berlin, Germany",{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":72,"phases":4,"briefSummary":332,"conditions":333,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":201},"100628627","evaluation-of-the-impact-of-interventional-treatments-for-symptomatic-severe-tricuspid-valve-insufficiency-on-renal-integrity-and-function-as-well-as-on-physical-function-and-activity-in-older-adults-100628627","NCT07464106","Evaluation of the Impact of Interventional Treatments for Symptomatic, Severe Tricuspid Valve Insufficiency on Renal Integrity and Function, as Well as on Physical Function and Activity in Older Adults.","TriRenGe","Inclusion Criteria:\n\n* Severe symptomatic tricuspid valve insufficiency and referral for TriClip\u002FTricValve screening\n* Completed 18th year of life\n* Ability to consent\n* Able to walk short distances with aids\n\nExclusion Criteria:\n\n* Dialysis-dependent\u002Fterminal kidney disease\n* Inability to comply with study-associated assessments (e.g., existing dementia)\n* Severe anemia (Hb \\\u003C7 g\u002Fdl)\n* Tricuspid valve intervention with palliative intent and likely imminent death\n* Lack of consent",{"count":331,"type":21},100,"The hypothesis is that renal function will improve following tricuspid valve intervention. A reduction in renal biomarkers is also expected. Furthermore, based on previous assessments, it is anticipated that there will be an improvement in volume status (reduced edema), symptom burden, and physical capacity in patients. Additionally, the study will assess the impact of the intervention on functional parameters such as motor capacity, physical activity, performance of activities of daily living, and ultimately, participation and quality of life.",[27,139,334,335],"Cardio-Renal Syndrome","Frailty","2026-03-09",{"date":338,"type":32},"2026-03-11",{"date":340,"type":32},"2025-02-01",{"date":342,"type":21},"2027-12",{"name":344,"class":93},"Robert Bosch Medical Center",{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":22,"phases":354,"briefSummary":355,"conditions":356,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":201},"100603197","tricuspid-uk-study-100603197","NCT07133386","TRicuspid Uk STudy","TRUST Trial Protocol","TRUST","Inclusion Criteria:\n\n* Patients aged \\>18 years at recruitment\n* Severe or more symptomatic TR determined by transthoracic echocardiography\n* Optimized medical and\u002For device therapy for a minimum of 30 days\n* Medications, including diuretics should be stable over the past 30 days\n* Baseline KCCQ 75 or less on minimum 2 assessments at least 2 weeks apart\n* New York Heart Association (NYHA) Functional Class II or ambulatory class IV\n* Morphology of tricuspid valve suitable for TEER with expectation of a reduction of severity of TR to moderate or less\n* Willing to provide written informed consent\n\nExclusion Criteria:\n\n* Presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results or result in an expected life expectancy of less than 12 months\n* Active malignancy associated with a prognosis of \\\u003C1 year\n* Left ventricular ejection fraction (LVEF)\\\u003C20%\n* Tricuspid valve leaflet anatomy which may preclude TriClip implantation, proper clip positioning on the leaflets or sufficient reduction in TR. This may include:\n\n  * Evidence of calcification in the grasping area\n  * Presence of a severe coaptation defect (\\>10mm) of the tricuspid leaflets. - Severe leaflet defect(s) preventing proper device placement\n  * Ebstein Anomaly - Identified by having a normal annulus position while the valve leaflets are attached to the walls and septum of the right ventricle.\n* Tricuspid valve anatomy not evaluable by transthoracic (TTE) or transoesophageal echo (TOE)\n* Rheumatic heart disease affecting the tricuspid valve\n* Indication for left-sided (e.g. severe aortic stenosis, severe mitral regurgitation) or pulmonary valve correction. Note: Patients with concomitant mitral and tricuspid valve disease will have the option of having any significant mitral regurgitation managed, then waiting 60 days prior to being reassessed for the current trial.\n* Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of the TriClip.\n* Tricuspid valve stenosis - Defined as a tricuspid valve orifice of ≤ 3.0 cm2 and\u002For mean gradient ≥3 mmHg as measured by the transthoracic echocardiography\n* Pregnant\n* Unable to comply with study protocol\n* Uncontrolled systemic hypertension with a systolic blood pressure \\>180mmHg or diastolic blood pressure \\>110mmHg\n* Severe pulmonary hypertension (sPAP\\>70mmHg) or fixed pre-capillary pulmonary hypertension assessed by cardiac catheterization\n* Stroke within prior 90 days\n* Chronic dialysis\n* Bleeding disorders or hypercoagulable state\n* Active peptic ulcer or active gastrointestinal (GI) bleeding\n* Ongoing infection requiring current antibiotic therapy (if temporary illness, patients may enrol 30 days after discontinuation of antibiotics with no active infection).\n* Known allergy or hypersensitivity to device materials\n* Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.\n* Enrolment in another clinical trial that involves treatment of tricuspid regurgitation",{"count":20,"type":21},[24],"This is a multicentre, randomised, placebo-controlled trial conducted at St Bartholomew's Hospital, John Radcliff Hospital, Royal Brompton Hospital, and Kings College London Hospital. The aim is to evaluate the benefits in health status from transcatheter edge to edge repair with the TriClip device in patients with severe or more symptomatic tricuspid regurgitation. A total of 150 patients will be recruited in a 1:1 ratio for TriClip or placebo. The primary endpoint of this study (change in Kansas City Cardiomyopathy Questionnaire between the treatment and placebo arm) will be analysed using a linear mixed model and compared between patients who receive the TriClip versus those who have a placebo procedure.\n\nStudy duration: 3 years",[27],"2026-02-26",{"date":359,"type":32},"2026-02-27",{"date":361,"type":21},"2026-07-31",{"date":363,"type":21},"2028-12",{"name":365,"class":93},"Barts & The London NHS Trust",{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":22,"phases":375,"briefSummary":376,"conditions":377,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":4},"100619843","combined-mitral-and-tricuspid-versus-isolated-mitral-transcatheter-edge-to-edge-repair-for-mitral-regurgitation-with-tricuspid-regurgitation-dual-teer-trial-100619843","NCT07349888","Combined Mitral and Tricuspid Versus Isolated Mitral Transcatheter Edge-to-Edge Repair for Mitral Regurgitation With Tricuspid Regurgitation (DUAL-TEER Trial)","Combined Mitral and Tricuspid Versus Isolated Mitral Transcatheter Edge-to-Edge Repair for Mitral Regurgitation With Tricuspid Regurgitation: A Randomized Controlled Trial","Inclusion Criteria General Inclusion Criteria\n\n* Age ≥ 18 years\n* Moderate-to-severe or severe (≥3+) degenerative mitral regurgitation (DMR) or functional mitral regurgitation (FMR) combined with severe (≥3+) functional tricuspid regurgitation (FTR)\n* New York Heart Association (NYHA) functional class II, III, or IVa\n* Anatomically suitable for transcatheter edge-to-edge repair, as assessed by the Heart Team\n* Willing and able to comply with the protocol requirements and data collection procedures\n* Capable of understanding the purpose of the trial and voluntarily providing written informed consent, either personally or via a legally authorized representative DMR Inclusion Criteria\n* Symptomatic moderate-to-severe or severe degenerative mitral regurgitation (MR ≥3+)\n* High surgical risk FMR Inclusion Criteria\n* Symptomatic moderate-to-severe or severe functional mitral regurgitation (MR ≥3+)\n\nFor ventricular FMR:\n\n* Left ventricular ejection fraction (LVEF) \\\u003C 50%\n* Persistent symptoms despite optimized guideline-directed medical therapy (GDMT) and cardiac resynchronization therapy (CRT), if indicated\n* Clinically stable for at least 30 days prior to enrollment\n\nFor atrial FMR:\n\n* Unsuitable for surgery\n* Persistent symptoms despite optimized medical therapy\n* Clinically stable for at least 30 days prior to enrollment TR Inclusion Criteria\n* Severe functional tricuspid regurgitation (TR ≥3+)\n* Persistent symptoms despite guideline-directed medical therapy (GDMT)\n* Clinically stable for at least 30 days prior to enrollment\n\nExclusion Criteria:\n\n* Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure (except dilated cardiomyopathy of ischemic or non-ischemic etiology)\n* Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)\n* Refractory heart failure requiring advanced therapies (e.g., left ventricular assist device or heart transplantation)\n* Left ventricular end-systolic diameter (LVESD) \\> 70 mm\n* Left ventricular ejection fraction (LVEF) ≤ 20%\n* Pulmonary arterial hypertension as assessed by right heart catheterization (RHC)\n* Severe right ventricular dysfunction, defined as:\n\nTricuspid annular plane systolic excursion (TAPSE) \\\u003C 10 mm, or Right ventricular tissue Doppler imaging S' \\\u003C 6 cm\u002Fs, or Fractional area change (FAC) ≤ 22%\n\n-Hemodynamic instability, defined as: Systolic blood pressure \\\u003C 90 mmHg with afterload reduction, or Cardiogenic shock requiring inotropic support, intra-aortic balloon pump, or ther mechanical circulatory support\n\n* Severe uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and\u002For diastolic blood pressure ≥ 110 mmHg)\n* Myocardial infarction or unstable angina within 30 days prior to enrollment\n* Significant untreated coronary artery disease requiring revascularization, or coronary intervention performed within 30 days prior to enrollment\n* Moderate or greater aortic valve or pulmonary valve stenosis or regurgitation Mitral valve anatomy deemed unfavorable for transcatheter edge-to-edge repair by the Heart Team, including:Moderate-to-severe calcification in the grasping zone; Mitral valve orifice area \\\u003C 3.5 cm²; Posterior mitral leaflet length \\\u003C 7 mm; Mitral stenosis; Leaflet perforation; Multi-segment disease or multiple chordal rupture Tricuspid valve anatomy deemed unfavorable for transcatheter edge-to-edge repair by the Heart Team, including:Moderate-to-severe calcification in the grasping zone; Coaptation gap ≥ 10 mm; Severe leaflet perforation, cleft lesions, or other conditions preventing device implantation\n* Congenital Ebstein's anomaly\n* Prior surgical or interventional procedure involving the mitral or tricuspid valve\n* Pacemaker or implantable cardioverter-defibrillator (ICD) leads interfering with proper device positioning\n* Intracardiac thrombus, vegetation, mass, or tumor in the atria or ventricles\n* Cerebrovascular accident (stroke) within 3 months prior to enrollment\n* Chronic obstructive pulmonary disease requiring continuous home oxygen therapy or long-term outpatient oral steroid treatment\n* End-stage renal disease requiring chronic dialysis\n* Vascular access limitations, including inferior vena cava filter, severely tortuous or obstructed caval system, or difficult transseptal puncture\n* Contraindications to antithrombotic therapy, or history of intracerebral hemorrhage, gastrointestinal bleeding, or bleeding disorders within 3 months prior to enrollment\n* Uncontrolled active infection, including active bacterial endocarditis\n* Severe comorbidities that may complicate treatment evaluation (e.g., coma, malignancy, or severe psychiatric disorders)\n* Pregnancy or breastfeeding\n* Life expectancy \\\u003C 1 year\n* Participation in another clinical trial that has not yet reached its primary endpoint\n* Investigator judgment that the patient is non-compliant or unlikely to complete follow-up as required",{"count":374,"type":21},404,[24],"This study aims to investigate the efficacy and safety of combined mitral and tricuspid transcatheter edge-to-edge repair (TEER) versus isolated mitral TEER in the treatment of patients with mitral regurgitation (MR) combined with tricuspid regurgitation (TR). The expected objective is to provide a more precise treatment strategy for patients with MR combined with TR, reduce surgical risks, improve survival rates and quality of life, and offer evidence for clinical practice. The main research content involves enrolling 404 patients with severe MR combined with TR, who will be randomly assigned to either the group receiving simultaneous mitral and tricuspid TEER or the group receiving isolated mitral TEER. The primary endpoint is the composite endpoint at one year postoperatively, including death during the one-year follow-up, mitral and\u002For tricuspid surgery or intervention due to mitral and\u002For tricuspid dysfunction, rehospitalization for heart failure, and an increase of \\\u003C15 points in the KCCQ score.",[107,27],"2026-01-16",{"date":249,"type":32},{"date":381,"type":21},"2026-02-01",{"date":383,"type":21},"2031-08-31",{"name":385,"class":93},"Nanjing First Hospital, Nanjing Medical University",{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":392,"sex":17,"minAge":18,"maxAge":393,"enrollmentInfo":394,"targetDuration":4,"studyType":72,"phases":4,"briefSummary":396,"conditions":397,"keywords":402,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":7},"100615460","a-multicenter-study-on-the-normal-reference-range-and-clinical-significance-of-the-right-atrioventricular-coupling-index-assessed-by-artificial-intelligence-based-three-dimensional-echocardiography-100615460","NCT07292896","A Multicenter Study on the Normal Reference Range and Clinical Significance of the Right Atrioventricular Coupling Index Assessed by Artificial Intelligence-Based Three-Dimensional Echocardiography","Healthy Adults Group\n\nInclusion Criteria:\n\n* Participants must meet all of the following criteria to be enrolled:\n\n  1. Of Han Chinese ethnicity\n  2. Aged 18-79 years\n  3. Normal blood pressure (\\\u003C 140\u002F90 mmHg)\n  4. Normal fasting blood glucose\n  5. Normal blood lipid levels (triglycerides, total cholesterol, low-density lipoprotein, high-density lipoprotein)\n  6. Normal complete blood count results (hemoglobin concentration, white blood cell count, red blood cell count, platelet count)\n  7. Normal liver and renal function (alanine transaminase \\\u003C 2× upper limit of normal; normal creatinine and blood urea nitrogen)\n  8. Normal electrocardiogram results (occasional atrial premature beats may be enrolled at the investigator's discretion)\n  9. No structural heart disease and normal cardiac function confirmed by echocardiography\n\nExclusion Criteria:\n\nParticipants will be excluded if they meet any of the following criteria:\n\n1. Clinically significant cardiac valve regurgitation (≥ mild severity)\n2. Respiratory diseases: acute or chronic respiratory disorders\n3. Endocrine diseases: thyroid disease, diabetes mellitus, hyperaldosteronism, pheochromocytoma, etc.\n4. Abnormal liver function (alanine transaminase \\> 2× upper limit of normal), abnormal renal function (elevated creatinine beyond normal range), or dyslipidemia (elevated triglycerides, total cholesterol, low-density lipoprotein, or high-density lipoprotein)\n5. Other systemic diseases: anemia, malignancy, connective tissue disease, large artery\u002Fperipheral vascular diseases (aortic dilation, aortic dissection, coarctation of the aorta, Takayasu arteritis, atherosclerosis), etc.\n6. Pregnant or lactating women\n7. Professional athletes\n8. Poor-quality ultrasound images that cannot support parameter measurement and analysis\n\nPulmonary Hypertension Group\n\nInclusion Criteria:\n\nPatients must meet all of the following criteria to be enrolled:\n\n1. Aged 18-79 years\n2. Confirmed diagnosis via right heart catheterization: mean pulmonary arterial pressure (mPAP) ≥ 20 mmHg, in accordance with the 2022 ESC\u002FERS guidelines\n\nExclusion Criteria:\n\nPatients will be excluded if they meet any of the following criteria:\n\n1. Unable to complete right heart catheterization or pressure-volume loop assessment\n2. Complicated with significant left heart disease (left ventricular ejection fraction \\[LVEF\\] \\\u003C 50%, significant mitral valve disease)\n3. Pericardial disease or arrhythmias (e.g., atrial fibrillation) that severely impair right heart function evaluation\n4. Poor-quality images that prevent accurate measurement of right atrial or right ventricular parameters\n5. Concurrent liver or renal disease\n6. Concurrent malignancy\n7. History of surgical procedures such as pulmonary endarterectomy or balloon pulmonary angioplasty\n\nHeart Failure Group\n\nInclusion Criteria:\n\nPatients must meet all of the following criteria to be enrolled:\n\n1. Aged 18-79 years\n2. Meets the 2022 AHA\u002FACC\u002FHFSA diagnostic criteria for heart failure\n\nExclusion Criteria:\n\nPatients will be excluded if they meet any of the following criteria:\n\n1.Complicated with significant valvular heart disease (e.g., severe mitral regurgitation, severe tricuspid regurgitation, etc.)\n\nTricuspid Regurgitation Group\n\nInclusion Criteria:\n\nPatients must meet all of the following criteria to be enrolled:\n\n1. Moderate or severe primary or secondary tricuspid regurgitation confirmed by echocardiography\n2. Aged 18-79 years\n\nExclusion Criteria:\n\nPatients will be excluded if they meet any of the following criteria:\n\n1. Pericardial disease or arrhythmias (persistent atrial fibrillation) that interfere with measurements\n2. Congenital heart disease or residual lesions after surgical correction\n\nAtrial Septal Defect Group\n\nInclusion Criteria:\n\nPatients must meet all of the following criteria to be enrolled:\n\n1. Secundum atrial septal defect confirmed by echocardiography or transesophageal echocardiography\n2. Patients who have not undergone closure or surgical correction, or stable patients with \\> 3 months postoperatively\n3. Aged 18-79 years\n\nExclusion Criteria:\n\n1.Complicated with other complex congenital heart diseases.",true,"79 Years",{"count":395,"type":21},2640,"This multicenter study aims to establish the normal reference range of the Right Atrioventricular Coupling Index (RACI) in healthy Chinese adults using AI-based 3DE technology. It will also analyze the correlation between RACI and physiological parameters such as age, gender, and body surface area. Additionally, the study will explore the variation characteristics of RACI in patients with pulmonary hypertension, heart failure, tricuspid regurgitation, and atrial septal defect, and evaluate the clinical value of RACI in disease diagnosis, differential diagnosis, and risk stratification.",[398,399,27,400,401],"Healthy Adults","Pulmonary Hypertension","Heart Failure","Atrial Septal Defect",[403,404,405],"Right Atrioventricular Coupling Index","3D Echocardiography","AI-assisted Imaging","2025-12-06",{"date":408,"type":32},"2025-12-18",{"date":410,"type":21},"2025-12",{"date":412,"type":21},"2026-12",{"name":414,"class":93},"First Hospital of China Medical University",{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":426,"conditions":427,"keywords":428,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":201},"100606201","early-phase-study-using-the-pivot-extend-system-as-a-treatment-for-patients-with-tricuspid-regurgitation-100606201","NCT07172477","Early Phase Study Using the 'Pivot Extend' System as a Treatment for Patients With Tricuspid Regurgitation","Early Feasibility Study (EFS) of the 'Pivot Extend' for the Treatment of Tricuspid Regurgitation, Including High-Risk Patients (SPACER Study, Australia)","SPACER","Inclusion Criteria:\n\n* Has voluntarily decided to participate in this clinical trial and has provided written informed consent\n* Adults aged 18 years or older at the time of informed consent\n* Has symptoms of TR corresponding to at least NYHA Class II, despite receiving optimal medical therapy for at least 30 days prior to screening\n* Meets the criteria at least severe (3+) on the TR grade classification table on echocardiography performed at the screening visit\n* Deemed suitable for percutaneous valve intervention by a Heart Team that includes at least one cardiologist and one cardiac surgeon\n* Is able to understand and follow the investigator's instructions and is able to participate for the entire duration of the study\n\nExclusion Criteria:\n\n* Has blood clots, emboli, masses, or growths in the vascular system of the heart or lungs on an echocardiogram and cardiac CT scan performed at the screening visit\n* Uncorrected blood clotting disorders based on hematology tests performed at the screening visit\n* Unable to use anticoagulant agents (NOAC ex.Xarelto)\n* A history of major bleeding (excluding minor bleeding such as nosebleed that can be hemostasized) treated with anticoagulants at any time prior to participation in this clinical trial\n* Severe anemia (hemoglobin less than or equal to 80g\u002FL)\n* Has an implanted device such as an implantable cardioverter defibrillator (ICD) or pacemaker\n* Has anatomy that, in the opinion of the investigator, is not suitable for implantation of an investigational medical device based on echocardiogram and cardiac CT scan performed at the screening visit\n* Requires surgery or interventional procedures (coronary artery bypass graft (CABG) or surgery for atrial septal defect (ASD)) based on an echocardiogram performed at the screening visit\n* Platelet count of 50 x 10\\^9 per litre of blood or less based on hematology tests performed at the screening visit\n* Pulmonary arterial hypertension, defined as pulmonary artery systolic pressure greater than 70mmHg on cardiac catheterization performed at the screening visit, or a pulmonary vascular resistance greater than 3 Wood Units on right heart catheterization\n* Left ventricular ejection fraction (LVEF) of less than 20% on echocardiogram performed at the screening visit\n* Active gastrointestinal bleeding or a digestive procedure within 90 days prior to screening for this study, and\u002For those with the potential for gastrointestinal bleeding in the opinion of the investigator\n* History of cerebrovascular accident (CVA) or transient ischemic attacks (TIA) within 30 days prior to screening for this clinical trial\n* History of myocardial infarction (MI) within 30 days prior to screening for this study\n* Active endocarditis requiring antibiotic treatment\n* Malignancies or end-stage renal failure requiring hemodialysis and other chronic conditions with a life expectancy of less than one year\n* Moderate or severe aortic, pulmonary artery, or mitral stenosis on echocardiogram performed at the screening visit\n* Severe or greater mitral valve regurgitation or severe aortic valve regurgitation as determined by echocardiographic grading criteria at the screening visit\n* Calcification of the tricuspid valve leaflets affecting the procedure on an echocardiogram performed at the screening visit\n* Those who have participated in another clinical trial within 30 days prior to screening for this clinical trial\n* Pregnant or breastfeeding, or planning to become pregnant during the clinical trial period\n* Participants of childbearing potential who are not using a highly effective method of contraception\n* Coexisting condition, which most likely limits the life expectancy to less than one year\n* Preexisting pulmonary valve prosthesis or a right ventricle to pulmonary artery (RV-PA) conduit\n* Any other clinical findings that, in the opinion of the investigator, are medically inappropriate for this clinical trial",{"count":424,"type":21},10,[24],"Participants with severe tricuspid regurgitation may require heart surgery to repair or replace the tricuspid valve. However, there is a high risk associated with these surgeries and it is often not feasible for elderly patients or those with other medical conditions.\n\nThe goal of this clinical investigation is\n\n* To assess the safety of the investigational device \"Pivot Extend\" in participants aged 18 years or over with severe and clinically symptomatic Tricuspid Regurgitation (TR) deemed suitable for percutaneous valve intervention\n* To evaluate device success, procedural success and clinical outcomes in improving TR symptoms following implantation of the \"Pivot Extend\" device",[27],[27,421,429],"Pivot Extend","2025-12-02",{"date":432,"type":32},"2025-12-09",{"date":434,"type":32},"2025-11-11",{"date":436,"type":21},"2027-03",{"name":438,"class":39},"Tau Medical Australia Pty Ltd",{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":443,"acronym":444,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":22,"phases":448,"briefSummary":449,"conditions":450,"keywords":453,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":4},"100569899","the-sttar-us-study-a-pivotal-study-of-transcatheter-tricuspid-annular-repair-in-the-us-100569899","NCT06700239","The STTAR-US Study: A Pivotal Study of Transcatheter Tricuspid Annular Repair in the US","STTAR-US","Inclusion Criteria:\n\n* Subject has severe functional TR (≥ 3). Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after any cardiac procedure(s)\n* In the judgment of the site's local heart team patient is at intermediate or greater risk for morbidity \\& mortality with tricuspid valve surgery, and has been adequately treated per applicable standards with optimized medical therapy for the treatment of TR (e.g. diuretics) and stable for at least 30 days prior to enrollment.\n* New York Heart Association (NYHA) Functional Class II, III or ambulatory class IV\n\nExclusion Criteria:\n\n* Systolic pulmonary artery pressure (sPAP) \\> 70 mmHg or \\> 5 wood units (WU) despite vasodilator therapy\n* Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and\u002For Diastolic Blood Pressure (DBP) ≥ 110 mm Hg\n* Previous tricuspid valve repair or replacement (transcatheter or surgical approach)\n* Subjects with concomitant left-sided valve disease will have the option of receiving a left-sided intervention (e.g. TMVR or TAVR) and waiting 60 days prior to being reassessed for the study\n* Myocardial infarction (MI), known unstable angina, symptomatic coronary artery disease (CAD) where revascularization is possible within 60 days prior to enrollment\n* Anatomy that precludes safe placement of anchors around the annulus\n* Hemodynamic instability defined as systolic pressure \\\u003C 90 mmHg requiring pressor support within the last 30 days\n\nEcho Criteria -\n\n* Subject has severe functional TR (determined by the ICL). Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after any cardiac procedure(s)\n* No presence of Cardiac Implantable Electronic Devices (CIED) leads causing the TR\n* No significant annular calcification\n* Left Ventricular Ejection Fraction (LVEF) ≥ 20%",{"count":447,"type":21},600,[24],"Purpose of this clinical study is to demonstrate the safety and efficacy of MIA-T system in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR grade ≥3) despite optimal medical therapy, who have been determined by the site's local heart team to be at intermediate or greater estimated risk for mortality and morbidity with tricuspid valve surgery.",[451,27,452],"Tricuspid Regurgitation Functional","Severe Tricuspid Valve Regurgitation",[454,455,456],"MIA-T","severe TR","severe functional TR","2025-11-24",{"date":459,"type":32},"2025-11-26",{"date":461,"type":21},"2025-12-31",{"date":463,"type":21},"2032-12",{"name":465,"class":39},"Micro Interventional Devices",{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":22,"phases":474,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":486},"100431969","trisol-system-efs-study-100431969","NCT04905017","Trisol System EFS Study","Early Feasibility Study of the Trisol System","Inclusion Criteria:\n\n1. Age \\>18 years.\n2. Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.\n3. Participant has symptomatic, moderate or greater functional or degenerative tricuspid regurgitation (TR) as determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and\u002For transesophageal echocardiogram (TEE).\n4. New York Heart Association (NYHA) Functional Class II to IVa.\n5. Participant is deemed at high surgical risk or greater for tricuspid valve surgery and appropriate for transcatheter tricuspid valve replacement as determined by the local Heart Team.\n6. Participant adequately treated based upon medical standards, including for coronary artery disease, mitral regurgitation, and Guideline-Directed Medical Therapy (GDMT) for heart failure for at least 30-days prior to index procedure.\n7. Male or non-pregnant female.\n8. Participant understands the nature of the procedure and provides written informed consent prior to any study specific assessments.\n9. Participant is willing and able to comply with the specified study requirements and follow-up evaluations.\n10. Participant is anatomically suitable for the Trisol system, including trans-jugular access as per imaging requirements, and is approved by the Subject Screening Committee\n\nExclusion Criteria:\n\n1. Previous tricuspid valve repair or replacement which may impede proper study device delivery or deployment.\n2. Stroke or transient ischemic event within the previous 90 days.\n3. Acute myocardial infarction within the previous 90 days.\n4. Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices.\n5. Untreated clinically significant coronary artery disease requiring revascularization.\n6. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within the previous 30 days.\n7. New or untreated right heart chamber or\u002Fand superior vena cava intracardiac mass, thrombus, or vegetation.\n8. Systolic pulmonary arterial pressure (sPAP) \\> 80 mmHg as measured by pulmonary pressure catheter.\n9. Severe RV dysfunction with RV Stroke Work Index (RVSWI) g\u002Fm2\u002Fbeat \\\u003C400 and Pulmonary Artery Pulsatile index (PAPi) \\\u003C2.\n10. Ongoing sepsis, including active endocarditis.\n11. Active infection requiring current antibiotic therapy.\n12. Known bleeding diathesis or hypercoagulable state.\n13. Blood dyscrasias as defined: leukopenia (WBC \\\u003C3000 cells\u002Fmm3), thrombocytopenia (platelet count \\\u003C50,000 cells\u002Fmm3).\n14. Active gastrointestinal (GI) bleeding or history of GI bleed within the previous 60 days that would preclude anticoagulation.\n15. LVEF \\\u003C25% as measured by resting echocardiogram within 30 days prior to index procedure.\n16. Patients in whom transesophageal echocardiography is contraindicated.\n17. Aortic, mitral or pulmonary valve disease (severe stenosis or severe regurgitation) requiring intervention or performed within 90 days prior to enrollment.\n18. Severe tricuspid valve stenosis.\n19. Need for any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days prior to index procedure.\n20. Need for emergent or urgent non cardiac surgery for any reason.\n21. Contraindication or known allergy to device components, anticoagulation therapy with a vitamin K antagonist, or to contrast media that cannot be adequately premedicated.\n22. History of cardiac transplantation, or participant currently listed for urgent transplant (e.g., UNOS Status 1).\n23. Presence of any known life-threatening non-cardiac disease that will limit the subject's life expectancy to less than one year.\n24. Contraindication or known hypersensitivity to anticoagulant therapy and\u002For antiplatelet therapy.\n25. Venous anatomy unsuitable for implant delivery.\n26. Pacemaker or ICD lead present that would prevent appropriate valve placement.\n27. Active COVID-19 infection.\n28. Comorbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study.\n29. Previously enrolled in this study or currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.",{"count":285,"type":21},[24],"The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).",[27],"2025-11-18",{"date":479,"type":32},"2025-11-21",{"date":481,"type":32},"2022-03-02",{"date":483,"type":21},"2031-07-01",{"name":485,"class":39},"Trisol Medical",7,{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":281,"officialTitle":281,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":22,"phases":495,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":506},"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":494,"type":21},120,[24],"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.",[27,140,289],"2025-10-30",{"date":500,"type":32},"2025-11-03",{"date":502,"type":32},"2023-03-01",{"date":504,"type":21},"2030-12-30",{"name":299,"class":39},21,{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":17,"minAge":514,"maxAge":515,"enrollmentInfo":516,"targetDuration":4,"studyType":22,"phases":517,"briefSummary":518,"conditions":519,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":201},"100606093","laplace-early-feasibility-study---canada-100606093","NCT07171060","Laplace Early Feasibility Study - Canada","Laplace Outside the US (OUS) Early Feasibility Study (EFS) Canada","Inclusion Criteria:\n\n1. 60 - 90 years of age at the time of the study procedure\n2. Symptomatic tricuspid regurgitation despite being adequately treated with optimal medical therapy by the Local Heart Team for at least 30 days prior to the time of study consent.\n3. Severe, massive or torrential tricuspid regurgitation determined by qualifying transthoracic echocardiogram (TTE) and\u002For transesophageal echocardiogram (TEE) using the 5-grade classification.\n4. Candidate felt suitable for transcatheter tricuspid valve replacement as determined by the local heart team and confirmed by the patient selection committee. For patients with pre-existing trans-tricuspid pacemaker or ICD leads, the local heart team shall include an electrophysiologist.\n5. Anatomically suitable for the Laplace TTVR system including trans-jugular access 6 Subject or legally authorized representative has provided informed consent and agrees to return for all required post-procedure follow-up visits\n\nExclusion Criteria:\n\n1. Estimated life expectancy of less than 12 months\n2. Systolic pulmonary artery pressure \\> 65mmHg per TTE.\n3. PVR \\>5 Wood units\n4. Acutely decompensated defined as hypotension with SBP \\\u003C90 mmHg, use of hemodynamic support devices or inotropes within the last 30 days\n5. Severe COPD dependent on home oxygen or chronic home oxygen use\n6. Echocardiographic evidence of severe right ventricular dysfunction\n7. Severe aortic, mitral and\u002For pulmonic valve stenosis and\u002For regurgitation requiring treatment\n8. New or untreated right heart chamber or\u002Fand superior vena cava intracardiac mass, thrombus, or vegetation\n9. Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.\n10. Untreatable hypersensitivity or contraindication to any of the following: Aspirin, and Clopidogrel or Ticlopidine, Heparin, and Bivalirudin, Warfarin, or DOAC, Nitinol Alloys. Severe renal insufficiency defined as eGFR \\\u003C25 mL\u002Fmin or requiring chronic renal replacement therapy at the time of screening committee review.\n\n12\\. Current history (within last 5 years) of illicit drug use. 13. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery, within last 30 days. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator or leadless pacemaker within 90 days prior to the study procedure 14. Need for emergent, urgent or planned surgery or intervention within 30 days following the study procedure. Planned or scheduled cardiac surgery within next 12 months. 15. Stroke or other major cerebrovascular event within 90-days prior to index procedure 16. Untreated clinically significant coronary artery disease requiring revascularization, recent (within last 30 days) acute coronary syndrome or myocardial infarction. 17. Active or recent GI bleed within 30 days prior to study procedure or patients Contraindicated for oral anticoagulation therapy 18. Bleeding disorders including thrombocytopenia or platelet count \\\u003C70,000 mm 3 or thrombocytosis (platelet count \\>700,000 \u002Fmm 3\n\n* Transfusion dependent chronic anemia with Hb \\\u003C9\u002FdL\n* Current or planned pregnancy within next 12 months for women of childbearing potential\n* Active or recent endocarditis within last 90 days or, sepsis\u002F other systemic infection requiring oral or intravenous antibiotics within last 30 days\n* Prior tricuspid repair or tricuspid replacement or other device that would interfere with successful deployment or functioning of Laplace tricuspid valve.\n* Participation in another pre-market investigational device study or investigational drug study for a cardiac related drug\n* Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements. Any patient considered to be vulnerable.\n* Left ventricular ejection fraction (LVEF) \\\u003C 30%\n* Deep vein thrombosis or pulmonary embolism within last 6 months\n* Child-Pugh C cirrhosis.\n* Contraindication or inability to complete TEE","60 Years","90 Years",{"count":135,"type":21},[24],"The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System",[27],"2025-09-05",{"date":522,"type":32},"2025-09-12",{"date":524,"type":32},"2024-06-18",{"date":526,"type":21},"2031-01-01",{"name":528,"class":39},"Laplace Interventional, Inc",{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":535,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":72,"phases":4,"briefSummary":539,"conditions":540,"keywords":541,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":506},"100518648","global-multicenter-registry-on-transcatheter-tricuspid-valve-replacement-100518648","NCT06033274","Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment","Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment: the TRIPLACE Registry","TRIPLACE","Inclusion Criteria:\n\n* Patients undergoing Transcatheter Tricuspid Valve Replacement\n* Native Tricuspid Valve disease\n* Orthotopic Tricuspid Valve Implantation\n\nExclusion Criteria:\n\n* Age under 18 years",{"count":538,"type":21},800,"The field of transcatheter tricuspid valve replacement (TTVR) is rapidly emerging and data on this topic are scarce. Particularly, little is known about which patients are at greatest risk of procedural complications, such as the timing and onset of conduction disturbances necessitating permanent pacemaker implantation, and how such patients are managed. On this background, the TRIPLACE Registry - an investigator-initiated global multicenter registry - is aimed at better understanding the safety and efficacy of orthotopic TTVR.",[27],[542,81,543],"valvular heart disease","transcatheter tricuspid valve replacement","2025-09-03",{"date":546,"type":32},"2025-09-10",{"date":548,"type":32},"2023-10-05",{"date":550,"type":21},"2026-08",{"name":552,"class":93},"Montefiore Medical Center",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":515,"enrollmentInfo":560,"targetDuration":4,"studyType":22,"phases":561,"briefSummary":562,"conditions":563,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":571,"locationsCount":201},"100603749","safety-and-feasibility-study-transcatheter-valve-repair-in-severe-symptomatic-functional-tricuspid-regurgitation-100603749","NCT07140562","Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation","Prospective, Multi-Center, Single-Arm Study: Safety and Technical Feasibility of the Tangent Tricuspid Annular Therapy System for Transcatheter Valve Repair in Patients With Severe, Symptomatic Functional Tricuspid Regurgitation","Inclusion Criteria:\n\n1. 18-90 years old at the time of consent\n2. Symptomatic functional tricuspid regurgitation (without co-existing degenerative disease) despite being adequately treated with optimal medical therapy by the Local Heart Team for at least 30 days prior to the study consent\n3. Severe, massive or torrential functional tricuspid regurgitation, as determined by qualifying transesophageal echocardiogram (TEE) and\u002For transthoracic echocardiogram (TTE) using the 5-grade classification\n4. TEE imaging confirms adequate visualization of valve for TR quantification and procedural guidance\n5. The Local Heart Team determines the candidate is suitable for transcatheter tricuspid valve repair\n6. Subject or legally authorized representative has provided informed consent and agrees to return for all required post-procedure follow-up visits\n\nExclusion Criteria:\n\n1. Estimated life expectancy of less than 12 months\n2. Systolic pulmonary artery pressure (sPAP) \\>70 mmHg as assessed by TTE or right heart catheterization\n3. Acutely decompensated, defined as hypotension with SBP \\\u003C90 mmHg, use of hemodynamic support devices or inotropes or uncontrolled arterial hypertension with SBP \\>180 mmHg within 30 days of the study procedure\n4. Severe COPD dependent on home oxygen or chronic home oxygen use\n5. Echocardiographic evidence of severe right ventricular dysfunction\n6. Severe aortic, mitral and\u002For pulmonic valve stenosis and\u002For regurgitation requiring treatment (prior transcatheter or surgical treatment allowable)\n7. Any condition that would interfere with the procedure, such as prior tricuspid valve repair, tricuspid valve leaflet anatomy which may preclude device implantation, pacemaker or Implantable Cardioverter Defibrillator (ICD) leads that would prevent appropriate placement or visualization of implant, Ebstein Anomaly (normal annulus position, but valve leaflets attached to walls and septum of the right ventricle)\n8. Tricuspid valve stenosis defined as a tricuspid valve orifice of ≤1.0 cm2 and\u002For mean gradient of ≥5 mmHg\n9. New or untreated right heart chamber and\u002For superior vena cava intracardiac mass, thrombus, or vegetation\n10. Degenerative tricuspid or rheumatic tricuspid valve disease\n11. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the study procedure\n12. Implant or revision of any rhythm management device (CRT or CRT-D, ICD, or leadless pacemaker) within 90 days prior to the study procedure\n13. Known need for emergent, urgent, or planned surgery or intervention within 30 days following the study procedure, or planned or scheduled cardiac surgery within 12 months following the study procedure\n14. Stroke or other major cerebrovascular event within 90 days prior to the study procedure\n15. Untreated clinically significant coronary artery disease requiring revascularization, recent (within 30 days of the study procedure) acute coronary syndrome or myocardial infarction\n16. Active or recent GI bleed within 30 days prior to the study procedure, or patients contraindicated for oral anticoagulation therapy\n17. Bleeding disorders including thrombocytopenia (platelet count \\\u003C70,000 mm3) or thrombocytosis (platelet count \\>700,000 mm3)\n18. Transfusion-dependent chronic anemia with Hb \\\u003C9\u002FdL\n19. Current or planned pregnancy within 12 months of the study procedure for women of childbearing potential\n20. Active or recent endocarditis within 90 days of the study procedure, or sepsis\u002Fother systemic infection requiring oral or intravenous antibiotics within 30 days of the study procedure\n21. Prior tricuspid repair or tricuspid replacement or prosthetic implant that would interfere with successful deployment or functioning of the Tangent Implant\n22. Participation in another pre-market investigational device study or investigational drug study (for a cardiac-related drug)\n23. Presence of other anatomic or co-morbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's availability to participate in the clinical investigation or to comply with follow-up requirements\n24. Any patient considered to be vulnerable\n25. Left ventricular ejection fraction (LVEF) \\\u003C30%\n26. Deep vein thrombosis or pulmonary embolism within 6 months of the study procedure\n27. Child-Pugh C cirrhosis",{"count":7,"type":21},[24],"The goal of this clinical trial is to evaluate the safety and technical success of the Tangent Tricuspid Annular Therapy System in patients with severe, symptomatic functional tricuspid regurgitation.",[451,564,27],"Tricuspid Regurgitation (TR)","2025-08-18",{"date":567,"type":32},"2025-08-24",{"date":569,"type":32},"2025-07-15",{"date":412,"type":21},{"name":572,"class":39},"Tangent Cardiovascular Inc.",{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":579,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":581,"targetDuration":4,"studyType":72,"phases":4,"briefSummary":583,"conditions":584,"keywords":585,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":201},"100586850","triclip-ced-rwe-study-100586850","NCT06920745","TriClip CED RWE Study","TRIClip CoverAge With Evidence Development (CED) Real-World Evidence (RWE) Study (TRICARE)","TRICARE","Inclusion Criteria:\n\n* Patients ≥ 18 years of age at time of implant\n* Patients with symptomatic, severe or greater Tricuspid Regurgitation who have received the TriClip system (treatment group) or have not undergone T-TEER (control group)\n\nExclusion Criteria:\n\n* Patients with less than severe Tricuspid Regurgitation\n* Patients with a prior history of surgical or transcatheter tricuspid valve replacement\n* Patients with a surgical or transcatheter aortic or mitral valve intervention within 90 days prior to index",{"count":582,"type":21},2200,"This Coverage with Evidence Development (CED) study evaluates the long-term health outcomes of patients with symptomatic, severe or greater Tricuspid Regurgitation who received a Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER) procedure using the TriClip system.",[27],[267,586,587],"Coverage with Evidence Development","Tricuspid Transcatheter Edge-to-Edge Repair","2025-08-06",{"date":590,"type":32},"2025-08-11",{"date":592,"type":32},"2025-07-08",{"date":594,"type":21},"2032-07",{"name":231,"class":39},{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":601,"acronym":4,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":603,"targetDuration":4,"studyType":72,"phases":4,"briefSummary":605,"conditions":606,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":201},"100599527","the-multi-center-study-of-comprehensive-atrial-fibrillation-regurgitation-and-recurrent-events-evaluation-100599527","NCT07085650","The Multi-center Study of Comprehensive Atrial Fibrillation Regurgitation and Recurrent Events Evaluation","The Multi-center Study of Comprehensive Atrial Fibrillation Regurgitation by 3-dimensional Transoesophageal Echocardiography and Recurrent Events Evaluation","Inclusion Criteria:\n\n1. Age ≥18 years old;\n2. Patients who came to the hospital with atrial fibrillation and intended to undergo ablation.\n\nExclusion Criteria:\n\n1. \\- History of left atrial or left atrial appendix thrombus, new cerebral infarction and myocardial infarction (\\\u003C 6 months);\n2. Congenital heart disease, valvular heart disease, dilated heart disease, hypertrophic cardiomyopathy, pacemaker implantation, artificial valve replacement;\n3. hyperthyroidism, severe liver and kidney insufficiency;\n4. Proposed cardiac pacemaker implantation;\n5. Previous history of catheter ablation;\n6. The quality of three-dimensional transesophageal images was insufficient and could not be analyzed;\n7. refuse to sign the informed consent.",{"count":604,"type":21},2000,"Atrial fibrillation (AF) is the most common cardiac arrhythmia in the clinic and can lead to valve regurgitation and a poor prognosis. At present, atrial fibrillation ablation is one of the most effective means for the recurrence of atrial fibrillation in clinical practice, but the recurrence rate is high. Therefore, it is of great significance to find the predictors of relapse after atrial fibrillation ablation for clinical precision treatment. three-dimensional transesophageal ultrasound (3D-TEE) can comprehensively evaluate the valve regurgitation, flap ring changes, atrial or auricular thrombosis in patients with atrial fibrillation. It is also a necessary examination before atrial fibrillation ablation.\n\nTherefore, this study intends to combine 3D-TEE and three-dimensional transthoracic echocardiographic (3D-TTE) examination to evaluate the cardiac structure and function of patients. To comprehensively evaluate atrial fibrillation valve regurgitation and explore the predictors of recurrence after atrial fibrillation ablation.",[607,107,27],"Atrial Fibrillation (AF)","2025-07-24",{"date":610,"type":32},"2025-07-25",{"date":612,"type":32},"2024-12-30",{"date":614,"type":21},"2026-09-30",{"name":414,"class":93}]