[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tricuspid-regurgitation-tr\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tricuspid-regurgitation-tr":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,46,78,101,123,157,180,213,239,258,283,305,329,357],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100640923","a-post-market-assessment-of-the-safety-and-performance-of-the-triclip-system-100640923",false,"NCT07586995","A Post-Market Assessment of the Safety and Performance of the TriClip™ System","A Post-Market Assessment of the Safety and Performance of the TriClip™ System (TREAT TR)","TREAT TR","Inclusion Criteria:\n\n1. Subject is eligible to receive the TriClip System per the current approved indications for use and is intended to undergo the procedure.\n2. Subject, or their legally authorized representative, has provided written informed consent prior to study procedure.\n3. Subject agrees to attend follow-up assessments.\n4. Subject is ≥ 18 years of age (or legal age of consent) at time of consent.\n\nExclusion Criteria:\n\n1. Subject is participating in another clinical study that could impact the follow-up or results of this study.\n2. Subject has an existing TriClip implant\n3. Presence of other conditions or factors that, in the Investigator's opinion, could limit the subject's ability to participate in follow-up.","ALL","18 Years",{"count":20,"type":21},1000,"ESTIMATED","OBSERVATIONAL","The objective of the TREAT TR study is to confirm the safety and performance of the TriClip System for tricuspid TEER in a contemporary, real-world setting, using the commercially available device in accordance with its approved indications for use.",[25],"Tricuspid Regurgitation (TR)",[27,28,29,30,31,25,32],"Tricuspid Regurgitation","Tricuspid","Cardiovascular","Tricuspid Valve Insufficiency","ABT-CIP-10594","Transcatheter Edge-To-Edge Repair (TEER)","RECRUITING","2026-06-30",{"date":36,"type":37},"2026-07-02","ACTUAL",{"date":39,"type":21},"2026-06",{"date":41,"type":21},"2033-08",{"name":43,"class":44},"Abbott Medical Devices","INDUSTRY",4,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100644068","phase-4-efficacy-of-verciguat-in-tr-and-rv-failure-100644068","NCT07668739","Efficacy of Verciguat in TR and RV Failure","Efficacy of Vericiguat in HFrEF Patients With Coexisting Severe Tricuspid Regurgitation and Right Heart Failure; Multicenter Pragmatic Randomized Controlled Trial","VERT-HF","Inclusion Criteria:\n\n1. Age more than 19 years old\n2. right ventricular malfunction confirmed with EKG data or cardiac MRI\n3. chronic heart failure with LVEF\\\u003C45%\n4. Patients Who administrated standard treatment of Heart Failur for over the 4 weeks\n5. NTproBNP \\>1000, NTproBNP \\>1600 with atrial fibrillation or The patient who recently experienced worsening heart failure(Recent hospitalization for worsening heart failure or outpatient administration of intravenous diuretics)\n6. Tricuspid regurgitation of greater than moderate severity was confirmed by echocardiogram\n7. Subject who provided voluntary informed consent to participate in the study\n8. Patients who have not been administered vericiguat within the last 6 months\n\nExclusion Criteria:\n\n1. Patients with a systolic blood pressure (SBP) \\\u003C 100 mmHg\n2. Patients currently treated with other sGC stimulators (including vericiguat) or phosphodiesterase-5 (PDE5) inhibitors\n3. Moderate-to-severe right ventricular (RV) failure requiring surgical intervention\n4. Patients who are currently pregnant or of childbearing potential","19 Years",{"count":56,"type":21},100,"INTERVENTIONAL",[59],"PHASE4","The goal of this clinical trial is to learn if the drug vericiguat works to improve right heart function in patients with worsening heart failure who have reduced left ventricular function. It will also examine the effects of the drug on tricuspid regurgitation (TR) and overall clinical outcomes.\n\nThe main questions it aims to answer are:\n\nDoes vericiguat improve right ventricular (RV) function and reduce tricuspid regurgitation (TR)? Does vericiguat reduce the risk of major adverse cardiovascular events (MACE), such as heart failure hospitalizations and cardiovascular death? Does vericiguat improve participants' exercise capacity, quality of life, and renal function?\n\nResearchers have previously seen the benefits of vericiguat in the large-scale VICTORIA trial for worsening heart failure, and it is hypothesized that improvements in right heart function play a key role. This study aims to confirm these specific benefits.\n\nParticipants will:\n\nTake vericiguat as prescribed during the study period. Undergo echocardiograms at enrollment and at 9 months to assess right heart function.\n\nComplete questionnaires (KCCQ-12) and walking tests (6MWT) to evaluate quality of life and exercise capacity.\n\nProvide blood samples to monitor NTproBNP levels and renal function (creatinine).",[62,25],"HFrEF",[62,64,65],"TR","Vericiguat","NOT_YET_RECRUITING","2026-06-23",{"date":69,"type":37},"2026-06-25",{"date":71,"type":21},"2026-07-01",{"date":73,"type":21},"2028-05-31",{"name":75,"class":76},"Daejeon St. Mary's hospital","OTHER",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":77},"100640652","efficacy-of-early-rhythm-control-in-af-with-tr-patients-100640652","NCT07607093","Efficacy of Early Rhythm Control in AF With TR Patients","TRAF","Inclusion Criteria:\n\n* Patients with concomitant atrial fibrillation and tricuspid regurgitation.\n\nExclusion Criteria:\n\n* Patients with a history of valvular surgery\n* Patients with congenital heart disease\n* Patients with primary pulmonary hypertension\n* Patients with CIED implantation prior to the diagnosis of tricuspid regurgitation\n* Patients diagnosed with TR only after the initiation of rhythm control therapy for AF",{"count":86,"type":21},5800,"Atrial fibrillation is frequently accompanied by tricuspid regurgitation and may contribute to right atrial and tricuspid annular remodeling, leading to progression of tricuspid regurgitation and adverse clinical outcomes. However, whether early rhythm control improves prognosis in patients with atrial fibrillation and tricuspid regurgitation remains unclear. This study will compare early rhythm control with usual care in these patients, using a composite outcome of cardiac death, heart failure admission, stroke, and tricuspid valve surgery.",[89,25],"Atrial Fibrillation (AF)",[91],"early rhythm control","2026-05-27",{"date":94,"type":37},"2026-05-29",{"date":96,"type":37},"2026-02-18",{"date":98,"type":21},"2027-02-28",{"name":100,"class":76},"Samsung Medical Center",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":77},"100639969","natural-history-of-atrial-fibrillation-induced-tricuspid-valve-remodeling-in-the-absence-of-significant-tricuspid-regurgitation-a-three-dimensional-echocardiographic-study-100639969","NCT07617974","Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation: A Three-Dimensional Echocardiographic Study","Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation: A Three-Dimensional Echocardiographic Study (TRICUSPID-AF)","TRICUSPID-AF","Inclusion Criteria:\n\n* Consecutive patients with atrial fibrillation (paroxysmal or persistent) undergoing transthoracic echocardiography (TTE) prior to AF ablation with acquisition of a 3D TV dataset.\n\nEligible for enrollment in the control group will be:\n\n1. all consecutive patients with structurally normal hearts and no history of AF or;\n2. moderate atrial functional tricuspid regurgitation and AF, in the absence of significant left-sided valvular disease or prior valvular surgery.\n\nExclusion Criteria:\n\n* Moderate or greater TR assessed using a multiparametric approach;\n* Arrhythmias other than AF;\n* Prior AF ablations;\n* Rapid ventricular response (average HR \\>110 bpm) during baseline TTE;\n* Inadequate image quality",true,{"count":111,"type":21},66,"This is a prospective, observational, multicenter study aimed at characterizing tricuspid valve remodeling in patients with atrial fibrillation (AF) without significant tricuspid regurgitation (TR), in relation to AF burden progression.",[89,25],"2026-05-26",{"date":116,"type":37},"2026-06-01",{"date":118,"type":37},"2026-05-04",{"date":120,"type":21},"2027-05-31",{"name":122,"class":76},"Centro Cardiologico Monzino",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":131,"targetDuration":133,"studyType":22,"phases":4,"briefSummary":134,"conditions":135,"keywords":141,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":4},"100638696","pascal-precision-gdmt-registry-100638696","NCT07578129","PASCAL Precision-GDMT Registry","Improvement in Guideline-Directed Medical Therapy After Tricuspid Transcatheter Edge-to-Edge Repair in Participants With Reduced Left Ventricular Function","PASCAL","Inclusion Criteria:\n\n* Participants of age ≥ 18 years\n* ≥ severe tricuspid regurgitation\n* LVEF \\\u003C 50%\n* Written informed consent of the patient or her\u002Fhis legal representative\n* Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up\n* Planned follow-up within a dedicated heart failure clinic as part of routine care.\n\nExclusion Criteria:\n\n* Anatomy unsuitable for TEER as determined by local heart team\n* severe mitral regurgitation (defined as an EROA\\>40 mm2) treated (surgically or percutaneously) less than 3 months prior\n* severe left ventricular dysfunction (defined as an LVEF \\\u003C20%)\n* systolic pulmonary artery pressure \\>70 mmHg (right heart catheterization)\n* prior tricuspid valve intervention\n* severe leaflet degeneration or tricuspid valve anatomy precluding successful device placement\n* primary tricuspid valve disease\n* COPD requiring home oxygen therapy\n* active endocarditis, or recent episode within 4 weeks of discontinuation of antibiotic therapy\n* participants with unstable hemodynamic condition\n* significant co-morbidities resulting in an expected less than 12-month life expectancy\n* The presence of other anatomic or comorbid conditions or other medical, social or psychological conditions that in the investigators' opinion could limit the subject's ability to participate in the clinical study and its follow-up.\n* Participants under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision\n* Participation in another trial, which would lead to deviations in the preparation or performance of the intervention or the post-implantation management from this protocol",{"count":132,"type":21},50,"12 Months","The goal of this observational study is to demonstrate that successful tricuspid valve repair with the PASCAL Precision System in participants with at least severe tricuspid insufficiency and left ventricular dysfunction will be associated with an improvement in up-titration of guideline-directed medical therapy (GDMT). The main question it aims to answer is:\n\nDoes the tricuspid insufficiency repair with the Pascal Precision System increases the dose of the medications used for heart failure therapy in the study population 12 months after tricuspid repair, as compared to the dose taken at baseline.\n\nParticipants undergoing tricuspid repair and fulfilling all inclusion\u002Fexclusion criteria will be asked to answer heart failure assessment as well as quality of life questionnaires at baseline and at 12 months post intervention. Medication monitoring will be performed throughout the study.",[136,25,137,138,139,140],"Tricuspid Insufficiency","Left Ventricular Cardiac Dysfunction","Left Ventricular (LV) Systolic Dysfunction","Left Ventricular Dysfunction","Left Ventricular Ejection Fraction",[142,143,144,145,146,147],"T-TEER","Severe Tricuspid regurgitation","left ventricular dysfunction","GDMT score","NHYA","KCCQ","2026-05-11",{"date":150,"type":37},"2026-05-13",{"date":152,"type":21},"2026-08-01",{"date":154,"type":21},"2027-08-31",{"name":156,"class":44},"Ceric Sàrl",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":57,"phases":167,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":4},"100633564","the-tricure-us-ide-pivotal-study-100633564","NCT07528326","The TRICURE US IDE Pivotal Study","TRiCares Topaz Transcatheter Tricuspid Heart Valve Replacement System IDE Pivotal Study","TRICURE US IDE","Inclusion Criteria:\n\n* Patient is ≥ 18 years of age\n* Patient has severe or greater tricuspid regurgitation with symptoms despite optimal medical therapy\n* Patient is an appropriate candidate to undergo TTVR as determined by the Institution Heart Team\n\nExclusion Criteria:\n\n* Patient has a tricuspid device currently in place\n* Patient has anatomical contraindications\n* Patient is in need of urgent surgery\n* Patient has a left ventricular ejection fraction of \\\u003C 25%\n* Patient has life expectancy of \\\u003C 1 year",{"count":166,"type":21},831,[168],"NA","The purpose of the study is to evaluate safety and effectiveness of the TRiCares Topaz TTVR system for treatment of subjects presenting with clinically relevant tricuspid regurgitation who are suitable for valve replacement.",[25],"2026-04-29",{"date":173,"type":37},"2026-05-05",{"date":175,"type":21},"2026-10",{"date":177,"type":21},"2035-09",{"name":179,"class":44},"TRiCares",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":189,"conditions":190,"keywords":196,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":77},"100608144","delineate-prospective-100608144","NCT07197736","DELINEATE-Prospective","Deep Learning for Echo Analysis, Tracking, and Evaluation Prospective Evaluation (DELINEATE-Prospective)","DELINEATE","Inclusion Criteria:\n\n* Attending cardiologist employed by Columbia University, ColumbiaDoctors, or NewYork Presbyterian Hospital who reads transthoracic echocardiograms in the Columbia echocardiography laboratory\n* Provided informed consent to take part in the questionnaires or pivotal study\n\nExclusion Criteria:\n\n* Physician in training (cardiology fellow or advanced imaging fellow)",{"count":132,"type":21},"Heart disease is the leading cause of death in the United States, and echocardiography (or \"echo\") is the most common way doctors look at the heart. Echo is safe, painless, and can detect major heart problems, including weak heart pumping and valve disease.\n\nValve disease, especially aortic stenosis (narrowing) and mitral regurgitation (leakage), is common in older adults but often goes undiagnosed. While echo is the main tool for finding valve problems, it takes time, requires expert training, and results can vary between readers.\n\nRecent advances in artificial intelligence (AI), especially deep learning (DL), have shown promise in automatically analyzing heart images. However, past research hasn't fully tackled key echo techniques-like color Doppler and spectral Doppler-that are crucial for measuring how blood moves through heart valves. AI tools also face challenges in being used in everyday medical practice because of workflow issues, lack of real-world testing, and concerns about how the algorithms make decisions.\n\nAt Columbia University Irving Medical Center, researchers have built a large database of heart tests over the last six years and developed AI programs to analyze echocardiograms. The current study will test whether providing AI analysis to cardiologists in real time during echo reading can make the process faster and more consistent.",[191,192,193,194,25,195],"Valve Disease, Aortic","Mitral Regurgitation (MR)","Aortic Stenosis","Valvular Heart Disease","Aortic Regurgitation",[197,198,199,200,201,202,203],"artificial intelligence","deep learning","valvular heart disease","echocardiography","cardiovascular disease","mitral regurgitation","aortic stenosis","2026-04-14",{"date":206,"type":37},"2026-04-16",{"date":208,"type":21},"2026-04-15",{"date":210,"type":21},"2028-10-01",{"name":212,"class":76},"Columbia University",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":220,"enrollmentInfo":221,"targetDuration":4,"studyType":57,"phases":223,"briefSummary":224,"conditions":225,"keywords":228,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":77},"100632627","robotic-transjugular-transcatheter-tricuspid-valve-replacement-100632627","NCT07516145","Robotic Transjugular Transcatheter Tricuspid Valve Replacement","Robotic Lux","Inclusion Criteria:\n\n* Age 18-90\n* Severe symptomatic TR\n* Deem high risk for tricuspid valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists) and\n* Anatomically feasible for transjugular transcatheter tricuspid valve replacement using the Lux-valve plus system\n* Able to consent\n\nExclusion Criteria:\n\n* Prior TV repair or replacement that would interfere with Lux-valve plus implantation\n* severe pulmonary hypertension (pulmonary artery systolic pressure \\>70 mm Hg or \\>2\u002F3 systemic with pulmonary vascular resistance \\>5 WU after vasodilator challenge)\n* Pregnant or nursing patients and those who plan pregnancy during the study period. Female patients of childbearing potential must have a negative pregnancy\n* Left Ventricular Ejection Fraction (LVEF) \\\u003C40% or;\n* Evidence of intracardiac mass, thrombus or vegetation or;\n* Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT or;\n* Surgical correction is indicated for other concomitant valvular disease (e.g., severe aortic, mitral and\u002For pulmonic valve stenosis and\u002For regurgitation); Subjects with concomitant valvular disease may treat their respective valve first and wait 2 months before being reassessed for the trial.\n* Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure or;\n* Active peptic ulcer or active gastrointestinal (GI) bleeding precluding anticoagulation or antiplatelet therapy or;\n* Underwent any cardiac or non-cardiac interventional or surgical procedure within 30 days prior to the procedure or planned to have the interventional or surgical procedure within 60 days after implant procedure (e.g., cardioversion, ablation, percutaneous coronary intervention, etc);\n* Recent (within 90 days prior to procedure) stroke, transient ischemic attack, or myocardial infarction;\n* Life expectancy is less than 1 year;\n* Current participation in another investigational drug or device study.","90 Years",{"count":222,"type":21},10,[168],"Valvular heart disease (VHD), caused by abnormalities in heart valves, can lead to severe complications such as heart failure and death, with approximately 220 million affected patients worldwide. The prevalence of VHD continues to grow alongside the aging global population. Transcatheter heart valve interventions have emerged as minimally invasive alternatives, offering benefits like shorter recovery times and reduced discomfort. However, current manual catheter-based techniques are complex, highly dependent on clinicians' expertise, and involve significant physical risk due to prolonged exposure to X-ray radiation and cumbersome protective gear.\n\nTo address these challenges, a novel, universal intracardiac robotic system is proposed to improve precision, safety, and procedural efficiency. This system integrates a high-dexterity, load-capacity catheter instrument, a modular concentric robotic platform, and an augmented reality (AR) navigation interface. The catheter's design balances flexibility for navigating complex intracardiac paths with the rigidity needed for device deployment. The robotic platform's modular architecture enhances versatility, enabling control across various procedures and anatomical variations, while the AR system facilitates intuitive preoperative planning and real-time intraoperative guidance through multimodal image fusion.\n\nThe core innovation lies in overcoming existing limitations: balancing catheter flexibility and load capacity, expanding robotic system adaptability for different valve procedures, and improving integration with imaging modalities like computed tomography, transesophageal echocardiogram, and fluoroscopy. The project aims to develop sophisticated models for instrument design, control strategies for multi-instrument coordination, and advanced navigation tools. These technological advancements are intended to elevate the clinical utility of robotic intracardiac interventions, making them safer, more efficient, and easier to adopt widely. By establishing a systematic approach for intelligent, multimodal, robotic-assisted valvular procedures, this work promises significant contributions to minimally invasive cardiology and holds substantial potential for clinical translation.",[25,226,227],"Valvular Heart Diseases","Transcatheter Valve Replacement",[27,229,227],"Valvular heart diseases","2026-03-31",{"date":232,"type":37},"2026-04-07",{"date":234,"type":37},"2026-03-12",{"date":236,"type":21},"2028-03-31",{"name":238,"class":76},"Prince of Wales Hospital, Shatin, Hong Kong",{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":4},"100631388","categorizing-patient-risk-for-tricuspid-regurgitation-tr-intervention-with-admittance-pulmonary-artery-catheter-system-apacs-100631388","NCT07500025","Categorizing Patient Risk for Tricuspid Regurgitation (TR) Intervention With Admittance Pulmonary Artery Catheter System (APACS)","Inclusion Criteria:\n\n* Patients with severe or torrential TR who are already scheduled to undergo clinically indicated tricuspid valve (TV) percutaneous replacement or clipping to reduce heart failure symptoms\n\nExclusion Criteria:\n\n* Children (defined as individual \\\u003C18 years of age) will be excluded from this study",{"count":246,"type":21},8,"The study is focused on evaluation of the effectiveness of the Admittance Pulmonary Artery Catheter (PAC) system for assessing the right ventricular (RV) function in patients with tricuspid regurgitation (TR) prior to tricuspid valve intervention.",[25],"2026-03-24",{"date":251,"type":37},"2026-03-30",{"date":253,"type":21},"2027-07-10",{"date":255,"type":21},"2028-07-10",{"name":257,"class":76},"Feldman Cardiology, PLLC",{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":17,"minAge":265,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":57,"phases":268,"briefSummary":269,"conditions":270,"keywords":271,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":4},"100627926","pivotal-trial-to-evaluate-transvenous-tricuspid-valve-replacement-with-lux-valve-plus-system-the-trinity-pivotal-trial-100627926","NCT07454980","Pivotal Trial to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (The TRINITY Pivotal Trial)","Pivotal TRIal to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With Lux Valve Plus System in Patients With Severe or Greater Tricuspid Regurgitation - Clinical SafetY and Effectiveness","Inclusion Criteria:\n\nFor the randomized study:\n\n1. Subject is at least 21 years of age at time of consent.\n2. Subject (or legal guardian) understands trial requirements and treatment procedures and is able to provide written informed consent.\n3. Severe or greater TR as assessed on transthoracic echocardiography by core lab.\n4. New York Heart Association (NYHA) Class II-IV.\n5. On optimal medical therapy (OMT) for TR at the time of baseline assessment per site Heart Team. OMT includes stable oral diuretic medications unless patient has a documented history of intolerance.\n6. The site Heart Team concurs that the patient is a good candidate for transcatheter tricuspid valve replacement and suitable for LuX-Valve Plus system by core lab.\n7. The commercial sponsor for EVOQUE deems that the patient is a good candidate for EVOQUE valve (control arm).\n\nFor single arm cohort (\"Not Suitable for Conventional TTVI\")\n\n1. Meets all criteria 1-6 above\n2. The EVOQUE commercial sponsor deems the anatomy unsuitable for EVOQUE tricuspid valve replacement, or the annular perimeter is smaller or greaterthan EVOQUE commercial Instructions for Use (IFU), as determined by the clinical site\n3. Two independent Structural Cardiologists determine the patient \"Not Suitable\" for Triluminate edge to edge repair\n\nExclusion Criteria:\n\n1. Left ventricular ejection fraction (LVEF) \\\u003C35%.\n2. Pulmonary arterial systolic pressure (PASP) \\>60 mmHg by echo Doppler (unless right heart catheterization \\[RHC\\] demonstrates PASP ≤60mmHg); in case RHC is performed, PASP \\>2\u002F3 systemic BP with PVR \\>5 Wood units after vasodilator challenge, in the absence of symptomatic hypotension or systolic BP \\\u003C90 mmHg.\n3. Evidence of intracardiac mass, thrombus, or vegetation.\n4. Ebstein Anomaly or congenital right ventricular dysplasia.\n5. Surgical or interventional correction is indicated for other concomitant valvular diseases (subjects with concomitant valvular disease may treat their respective valve first and wait 2 months before being reassessed for the trial).\n6. Subjects with valve prostheses implanted in the tricuspid valve.\n7. Pre-existing prosthetic valve(s) (other than tricuspid ones) with clinically significant prosthetic dysfunction.\n8. Active infection, infective endocarditis or sepsis within 3 months, or infections requiring antibiotics treatment within two weeks prior to planned procedure.\n9. Untreated clinically significant coronary artery disease requiring revascularization.\n10. Acute myocardial infarction or unstable ischemia-related angina within 30 days prior to the planned procedure.\n11. Any percutaneous coronary, intracardiac or carotid intervention within 30 days prior to the planned procedure.\n12. Cerebrovascular stroke (ischemic or bleeding) within 3 months prior to enrollment.\n13. Active peptic ulcer or active gastrointestinal bleeding within 3 months prior to enrollment.\n14. Blood dyscrasias as defined: leukopenia (WBC \\\u003C1000 mm3), thrombocytopenia (platelet count \\\u003C50,000 cells\u002Fmm3), history of bleeding diathesis, or coagulopathy.\n15. Inability to tolerate anticoagulation or antiplatelet therapy.\n16. Renal insufficiency (eGFR\\\u003C 30ml\u002Fmin \\[per the CKD-EPI formula\\] and\u002For renal replacement therapy).\n17. Patients with hepatic insufficiency or cirrhosis with Child-Pugh score class C\n18. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements.\n19. Severe Chronic Obstructive Pulmonary Disease requiring steroids or requiring continuous home oxygen.\n20. Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, or contrast media.\n21. Estimated life expectancy \\\u003C12 months.\n22. Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.\n23. Subjects with current history of illicit drug use.\n24. Any other condition making it unlikely the patient will be able to complete all protocol procedure and follow-ups determined by the investigator.","21 Years",{"count":267,"type":21},680,[168],"The goal of this clinical trial is to learn if LuX-Valve Plus system works to treat symptomatic subjects with at least severe tricuspid regurgitation (TR). It will also learn about the safety of LuX-Valve Plus system.\n\nResearchers will compare LuX-Valve Plus system to a conventional device called EVOQUE to see if LuX-Valve Plus system works to treat subjects with at least severe tricuspid regurgitation.\n\nParticipants will:\n\nUndergo one procedure using the LuX-Valve Plus system or EVOQUE after passing screening and enrolling in the trial; Complete follow-up visits and examinations as required by the trial protocol; Report any adverse events",[25],[27,272,273],"Transvenous Tricuspid Replacement","LuX-Valve Plus System","2026-03-05",{"date":276,"type":37},"2026-03-06",{"date":278,"type":21},"2026-05",{"date":280,"type":21},"2038-12",{"name":282,"class":44},"Jenscare Innovation Inc.",{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":220,"enrollmentInfo":290,"targetDuration":4,"studyType":57,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":77},"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":291,"type":21},25,[168],"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.",[295,25,27],"Tricuspid Regurgitation Functional","2025-08-18",{"date":298,"type":37},"2025-08-24",{"date":300,"type":37},"2025-07-15",{"date":302,"type":21},"2026-12",{"name":304,"class":44},"Tangent Cardiovascular Inc.",{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":57,"phases":314,"briefSummary":315,"conditions":316,"keywords":317,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":326,"locationsCount":328},"100583530","early-feasibility-of-pivot-extend-for-tricuspid-regurgitation-treatment-100583530","NCT06877520","Early Feasibility of 'Pivot Extend' for Tricuspid Regurgitation Treatment","Early Feasibility Study (EFS) of the 'Pivot Extend' in Treatment for Tricuspid Regurgitation (SPACER Study)","Inclusion Criteria:\n\n1. Adults 18 years of age or older at the time of screening\n2. Those with symptoms despite medical therapy (OMT, diuretics\u002Fmedications) for TR for at least 1 month at screening\n3. Those who meet the criteria of severe (3+) or worse on the TR grade classification table on echocardiography performed at the screening visit\n4. Those with clinical symptoms of New York Heart Association (NYHA) class 2 or worse\n5. Those deemed suitable for percutaneous valve intervention by a Heart Team that includes at least one cardiologist, one cardiac surgeon and one anesthesiologist.\n6. Those who have voluntarily decided to participate in this clinical trial and have provided written informed consent\n7. Those who can understand and follow the investigator's instructions and are able to participate for the entire duration of the study\n\nExclusion Criteria:\n\n1. Those with 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\n2. Those with uncorrected blood clotting disorders based on hemanalysis performed at the screening visit\n3. Those who are unable to use anticoagulant agents (NOAC ex.Xarelto)\n4. Those who have had major bleeding (not including minor bleeding, such as a nosebleed that can be hemostasized) treated with anticoagulants prior to participation in this clinical trial\n5. Those with severe anemia (hemoglobin ≦10g\u002FdL) that requires hospitalization\n6. Those who have an implanted device such as an implantable cardioverter defibrillator (ICD) or pacemaker prior to participation in this clinical trial\n7. Those whose anatomy, 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\n8. Those who require 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\n9. Those with a platelet count of 80,000\u002FuL or less based on hemanalysis performed at the screening visit\n10. Patients with pulmonary arterial hypertension with a TR Vmax greater than 3.5 m\u002Fs on echocardiography performed at the screening visit or a pulmonary vascular resistance of more than 3 Wood Units on right heart catheterization\n11. Those with a left ventricular ejection fraction (LVEF) of less than 50% on echocardiogram performed at the screening visit\n12. Those who have had active gastrointestinal bleeding or a digestive procedure within 3 months prior to participation in this study (those with the potential for gastrointestinal bleeding)\n13. Those with a history of cerebrovascular accident (CVA) or transient ischemic attacks (TIA) within 30 days prior to participation in this clinical trial\n14. Those with a history of myocardial infarction (MI) within 30 days prior to participation in this study\n15. Those with active endocarditis requiring antibiotic treatment\n16. Those with malignancies with end-stage renal failure requiring hemodialysis and other chronic conditions who have a life expectancy of less than one year\n17. Those with moderate or severe aortic, pulmonary artery, or mitral stenosis on echocardiogram performed at the screening visit\n18. Those with moderate or worse mitral valve regurgitation or severe aortic valve regurgitation on the echocardiogram performed at the screening visit\n19. Those with calcification of the tricuspid valve lobes affecting the procedure on an echocardiogram performed at the screening visit\n20. Those who have participated in another clinical trial within 30 days prior to participation in this clinical trial\n21. Pregnant or nursing women, or women planning to become pregnant during the clinical trial period\n22. Women of childbearing potential who are not using a medically accepted birth control method\n23. Those with a coexisting condition, which most likely limits the participant´s life expectancy to less than one year.\n24. Those with a preexisting pulmonary valve prosthesis or RV to PA conduit.\n25. Those with clinical findings other than the above that, in the opinion of the investigator, are medically inappropriate for this clinical trial",{"count":313,"type":21},7,[168],"This clinical trial aims to evaluate the safety and demonstrate the efficacy of treatment to improve tricuspid regurgitation (TR) symptoms in patients with severe and clinically symptomatic TR through long-term implantation of an investigational medical device.\n\n1. Determine the safety of long-term implantation of the investigational medical device \"Pivot Extend\" by monitoring for MACEs associated with the investigational medical device or procedure that may occur with long-term associated with the investigational medical device or procedure that may occur with long-term implantation.\n2. Device success, procedural success, and clinical outcomes of long-term implantation of the investigational medical device \"Pivot Extend\" will be monitored.",[25],[318,319],"Pivot Extend","TauMedical","2025-04-10",{"date":322,"type":37},"2025-04-11",{"date":324,"type":21},"2025-05",{"date":302,"type":21},{"name":327,"class":44},"Tau-MEDICAL Co., Ltd.",3,{"id":330,"slug":331,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":338,"conditions":339,"keywords":340,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":77},"100585481","impact-of-severe-tricuspid-regurgitation-correction-on-gut-microbiota-and-gastrointestinal-function-100585481","NCT06902922","Impact of Severe Tricuspid Regurgitation Correction on Gut Microbiota and Gastrointestinal Function","Tri-GuM","Inclusion Criteria:\n\n* Adult patients, able to sign the Informed Consent Form, admitted to OSR Heart Valve Center with TR ≥ severe treated with T-TEER.\n\nExclusion Criteria:\n\n* Concomitant ≥ severe MR. Such patients may be treated with M-TEER and be re-evaluated after 3 months: if TR is ≥ severe and MR is ≤ moderate the patient may then be enrolled.\n* Surgical candidates\n* Recent \\\u003C 6 months cardiac coronary or structural procedure\n* CAD requiring intervention\n* other valvular disease \\> moderate\n* Treatment with transcatheter tricuspid replacement\n* Age \\\u003C18 years\n* Inability or unwillingness to sign informed consent\n* Kidney dialysis\n* Acute infection\n* Inflammatory bowel diseases\n* Gastrointestinal diseases\n* Previous gastrointestinal surgery\n* Active cancer\n* Active autoimmune or inflammatory diseases\n* Treatments with antibiotics or probiotics within one month\n* Emergency procedures\n* Patients enrolled in interventional studies that may confound study results",{"count":337,"type":21},150,"Tricuspid regurgitation (TR) is gaining increasing attention within the cardiological community due to its poor prognosis, challenging clinical presentation and difficult treatment.\n\nTR causes decreased forward cardiac output and increased intravascular pressure upstream, which lead to peripheral oedema, ascites, hepatic congestion and kidney failure.\n\nThe microbiota is also getting increasing attention and changes in microbiota have been already associated with cardiovascular disease.\n\nThe impact of hemodynamic effects of TR on the gut microbiota however is still unknown.\n\nPatients affected by TR frequently complain abdominal distension and anorexia. We hypothesize that, due to increased venous congestion, TR may induce impaired gut function with modification in the microbiota and that TR correction may induce reverse changes.\n\nThis study will enroll patients treated with Transcatheter Tricuspid Edge-to-Edge Repair (T-TEER) at the Valve Center of San Raffaele Hospital due to severe TR.\n\nIn addition to the standard of care, before T-TEER, for all patients 2 additional blood samples, 1 urine and 1 fecal sample will be collected.\n\n3 months after the procedure, all patients will be re-assessed at the Valve Center outpatient clinic as standard of care. At this stage for all patients 2 blood samples, 1 urine and 1 fecal sample will be collected again for the purpose of the study. The microbiota metabolites of patients after 3 months from the procedure will be compared to those at baseline according to the degrees of residual TR.\n\nTo assess the reproducibility of the microbiota results and to explore an intrinsic short-term variation in microbiome composition within single patients, a subgroup of 30 patients will undergo a low intervention substudy repeating the measurements (2 blood, 1 urine and 1 fecal) within 10 days, both at baseline and at follow-up.",[25],[341,342,343,344,345,346,347,142],"tricuspid regurgitation","gut microbiota","gastrointestinal","heart","heart valve disease","tricuspid valve disease","transcatheter","2025-03-24",{"date":350,"type":37},"2025-03-30",{"date":352,"type":21},"2025-03-31",{"date":354,"type":21},"2027-09-30",{"name":356,"class":76},"Francesco Maisano",{"id":358,"slug":359,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":365,"conditions":366,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":77},"100578690","pacemaker-implantation-following-transcatheter-tricuspid-valve-replacement-100578690","NCT06814574","Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement","Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement - Single Center Experience","Inclusion Criteria:\n\n* Transcatheter Tricuspid Valve Replacement\n\nExclusion Criteria:\n\n* no defined exclusion criteria",{"count":291,"type":21},"Transcatheter tricuspid valve replacement (TTVR) is associated with a high risk of third-degree atrioventricular block (AVB). However, the optimal pacemaker management following TTVR remains unclear. This study aims to identify an optimal therapeutic approach for pacemaker implantation in patients undergoing TTVR.",[367,25],"AV Block Complete","2025-02-06",{"date":370,"type":37},"2025-02-07",{"date":372,"type":37},"2024-01-01",{"date":374,"type":21},"2025-01-31",{"name":376,"class":76},"Deutsches Herzzentrum Muenchen"]