[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tricuspid-regurgitation-functional\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tricuspid-regurgitation-functional":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,72,96,123],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100622592","acute-safety-and-efficacy-of-the-pivot-bridge-system-for-functional-tricuspid-regurgitation-100622592",false,"NCT07385625","Acute Safety and Efficacy of the Pivot Bridge System for Functional Tricuspid Regurgitation","The Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat Functional Tricuspid Regurgitation","Pivot TR","Inclusion Criteria:\n\nSubjects who meet all of the following criteria will be enrolled\n\n* Adults aged 18 years or older at the time of screening\n* Subjects who have received appropriate medical treatment (diuretics\u002Fmedical therapy) for tricuspid regurgitation for at least 1 month prior to participation in this clinical trial\n* Subjects who, at the screening visit, are assessed by transthoracic echocardiography (TTE) to have functional tricuspid regurgitation severity of Massive (4+) or greater, as defined by Tricuspid Valve Academic Research Consortium classification, and who have clinical symptoms corresponding to New York Heart Association (NYHA) functional class II or higher\n* Subjects who, at the screening visit, are found on TTE or cardiac computed tomography (CT) to have a right ventricle (RV) larger than the left ventricle (LV)\n* Subjects who, at the screening visit, are found on cardiac CT to have an annular diameter of 40 mm or greater\n* Subjects for whom the Heart Team, consisting of at least one cardiologist (specialist in cardiology) and at least one cardiac surgeon, has determined that surgical treatment for isolated Tricuspid Regurgitation is required\n* Subjects who voluntarily decide to participate in this clinical trial and provide written informed consent on the subject consent form\n* Subjects who are able to understand and comply with the investigator's instructions and participate throughout the entire clinical trial period\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will be excluded\n\n* Subjects in whom thrombus or embolic material is identified on echocardiography or cardiac computed tomography (CT) performed at the screening visit\n* Subjects who have uncorrected coagulation disorders as shown by clinical laboratory tests performed at the screening visit\n* Subjects who cannot use anticoagulant agents\n* Subjects who, prior to participation in this clinical trial, have experienced major bleeding due to the use of anticoagulants (minor bleeding such as controllable epistaxis does not apply) requiring treatment, or who have had severe anemia necessitating hospitalization\n* Subjects who, prior to participation in this clinical trial, have had devices such as an implantable cardioverter defibrillator (ICD) or a pacemaker implanted\n* Subjects who, based on echocardiography and cardiac CT performed at the screening visit, are judged by the investigator to have anatomical structures unsuitable for implantation of the investigational medical device\n* Subjects who, based on clinical laboratory tests performed at the screening visit, have a platelet count of ≤80,000\u002FµL\n* Subjects who, based on echocardiography performed at the screening visit, have pulmonary hypertension with TR Vmax ≥3.5 m\u002Fs\n* Subjects who, based on echocardiography performed at the screening visit, have left ventricular ejection fraction (LVEF) \\\u003C50%\n* Subjects who, within 3 months prior to participation in this clinical trial, have had active gastrointestinal bleeding or have undergone gastrointestinal procedures (subjects with a risk of gastrointestinal bleeding)\n* Subjects who, within 30 days prior to participation in this clinical trial, have a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA)\n* Subjects who, within 30 days prior to participation in this clinical trial, have a history of myocardial infarction (MI)\n* Subjects with active infective endocarditis requiring antibiotic therapy\n* Subjects with severe terminal illnesses (e.g., malignant tumors, end-stage pulmonary disease, end-stage liver disease, end-stage renal failure)\n* Subjects who, based on echocardiography performed at the screening visit, have moderate or severe aortic, pulmonary, or mitral stenosis\n* Subjects who, based on echocardiography performed at the screening visit, are found to have calcification of the tricuspid valve leaflets that would affect the procedure\n* Subjects who, based on echocardiography performed at the screening visit, are found to have masses, thrombi, or proliferative lesions in the right heart system, femoral vein, or inferior vena cava\n* Subjects who, within 30 days prior to participation in this clinical trial, have participated in another clinical trial\n* Pregnant or lactating women, and women planning to become pregnant during the study period\n* Women of childbearing potential who are not using medically acceptable methods of contraception\n* Subjects who, in addition to the above, are deemed by the investigator to have clinically significant findings that make them inappropriate for participation in this trial","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this clinical trial is as follows.\n\nTo assess the safety of the investigational medical device \"Pivot Bridge\" in participants aged 18 years or older with massive or greater functinal tricuspid regurgitation (TR) who have received medical therapy (diuretics\u002Fpharmacological treatment) for at least one month.\n\nTo evaluate clinical outcomes related to improvement of tricuspid regurgitation symptoms following implantation of the \"Pivot Bridge\" device, including procedure success and clinical success.\n\nThis study is designed as a self-controlled case series without a separate control group. The participant's non-exposure period to the investigational medical device, consisting of prior medical therapy (Medical Treatment, MT), is defined as the control period. The study compares (1) a period of fixed-dose medical therapy maintained for up to one week prior to application of the investigational medical device, and (2) a period during which the investigational medical device is temporarily implanted (within 1 week) in conjunction with medical therapy (Pivot Bridge, PB).\n\nTo quantitatively evaluate the efficacy of the investigational medical device in inducing improvement of tricuspid regurgitation, the following are assessed:\n\n1. improvement in regurgitation severity from baseline to Day 4-7 during fixed-dose medical therapy (ΔMT), and\n2. improvement from pre-application to the time of device removal following additional application of the Pivot Bridge (ΔPB).",[27],"Tricuspid Regurgitation Functional",[29,30,31],"Tricuspid Regurgitation","SPACER","Pivot Bridge","RECRUITING","2026-01-26",{"date":35,"type":36},"2026-02-04","ACTUAL",{"date":38,"type":36},"2025-11-20",{"date":40,"type":21},"2027-06",{"name":42,"class":43},"Tau-MEDICAL Co., Ltd.","INDUSTRY",4,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"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":53,"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.",[27,29,57],"Severe Tricuspid Valve Regurgitation",[59,60,61],"MIA-T","severe TR","severe functional TR","NOT_YET_RECRUITING","2025-11-24",{"date":65,"type":36},"2025-11-26",{"date":67,"type":21},"2025-12-31",{"date":69,"type":21},"2032-12",{"name":71,"class":43},"Micro Interventional Devices",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"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","90 Years",{"count":81,"type":21},25,[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.",[27,85,29],"Tricuspid Regurgitation (TR)","2025-08-18",{"date":88,"type":36},"2025-08-24",{"date":90,"type":36},"2025-07-15",{"date":92,"type":21},"2026-12",{"name":94,"class":43},"Tangent Cardiovascular Inc.",1,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100532391","innoventric-trillium-stent-graft-early-feasibility-study-efs-100532391","NCT06212193","Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)","Early Feasibility Study (EFS) to Assess the Safety and Performance of the Innoventric Trillium™ Stent Graft in the Treatment of Severe or Greater Tricuspid Regurgitation (TR)","Inclusion Criteria:\n\n* Patient has clinically significant TR graded as severe or greater\n* Peak central venous pressure of ≥ 15mmHg\n* Patient has NYHA functional classification of III or IV\n* Patient is not eligible for standard-of-care surgical or interventional therapy or has refused standard-of-care surgical and interventional therapy or has received standard-of-care TR therapy and remains symptomatic\n\nExclusion Criteria:\n\nPatients will be excluded from participation if ANY of the following criteria apply:\n\n* Severe RV dysfunction defined by TAPSE, RVEF, or RVFAC.\n* Anatomical suitability according to CT scan.\n* Systolic Pulmonary Artery Pressure \\> 65mmHg\n* Moderate or more mitral valve stenosis\n* Greater than moderate mitral valve regurgitation or aortic valve stenosis\u002Fregurgitation\n* Moderate mitral valve regurgitation combined with moderate aortic valve stenosis\u002Fregurgitation\n* Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) \\\u003C 35 ml\u002Fmin\u002F1.73 m2 within 60 days prior to the index procedure or patient is on chronic dialysis\n* Liver cirrhosis or moderate or severe liver disease (Child-Turcotte-Pugh class B or C, or a score of 7 or higher)\n* Thrombocytopenia (Platelet count\\\u003C 80,000\u002Fmm3) or thrombocytosis (Platelet count \\> 750,000\u002Fmm3) within 14 days of the index procedure\n* In the opinion of the Investigator or the study eligibility committee, the patient's life expectancy \\\u003C 12 months","85 Years",{"count":105,"type":21},15,[24],"Early Feasibility Study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR).",[29,27],[110,111,29,112],"Tricuspid valve","Transcatheter","Tricuspid valve insufficiency","2025-03-05",{"date":115,"type":36},"2025-03-07",{"date":117,"type":36},"2024-08-05",{"date":119,"type":21},"2030-08",{"name":121,"class":43},"Innoventric LTD",12,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"100430879","early-feasibility-study-of-the-cardiac-implants-percutaneous-ring-annuloplasty-system-100430879","NCT04890821","Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System","Early Feasibility Study (EFS) of the Cardiac Implants Percutaneous Ring Annuloplasty System for the Treatment of Functional Tricuspid Regurgitation","Inclusion Criteria:\n\n1. Moderate to severe functional tricuspid regurgitation (TR) defined by ASE guidelines and the European Association of Echocardiography guidelines.\n2. Tricuspid valve annular diameter ≥ 40mm or \\> 21 mm\u002Fm2 as measured by baseline TTE in a 4-chamber view within 90 days prior to index implant procedure.\n3. Age ≥ 18 years old at the time of enrollment.\n4. New York Heart Associate Classification ≥ II.\n5. Symptoms of right heart failure despite optimized medical therapy.\n6. Multidisciplinary heart team (minimum of four physicians, including imaging, Structural Heart Disease Interventionalist, Heart Failure Cardiologist, and Cardiac Surgeon) agree that percutaneous tricuspid annuloplasty is a reasonable treatment.\n7. Left Ventricular Ejection Fraction (LVEF) ≥ 30% within 90 days prior to index implant procedure\n8. The subject has suitable anatomy for investigational device implantation as per imaging requirements.\n9. The subject has read and signed the informed consent prior to study related procedures.\n10. The subject is willing and able to comply with all required follow-up evaluations and assessments.\n\nExclusion Criteria:\n\n1. Acute decompensated heart failure requiring hospital admission with 4 weeks of enrollment.\n2. Severe RV dysfunction as assessed by echocardiography.\n3. Primary (organic) tricuspid pathology (e.g. rheumatic, congenital, infective, etc.).\n4. Currently participating in another investigational drug or device study.\n5. Systolic pulmonary arterial pressure (sPAP) \\> 70 mmHg as measured by Transthoracic Echocardiography (TTE).\n6. Subject requiring another cardiac procedure in the framework of the index procedure; subject requiring a percutaneous procedure within 30 days before or after the procedure or a cardiac surgical procedure within 3 months before or after the procedure.\n7. Tricuspid valve stenosis.\n8. Aortic, mitral and\u002For pulmonic valve stenosis and\u002For regurgitation more than moderate.\n9. Intra-cardiac thrombus, mass or vegetation requiring active treatment.\n10. Prior tricuspid repair or tricuspid replacement.\n11. Known allergy to contrast media, stainless steel or nitinol that cannot be adequately pre-medicated.\n12. History of cardiac transplantation.\n13. Contraindication to Transthoracic\u002FTransesophageal Echocardiography (TTE\u002FTEE).\n14. Endocarditis or severe infection within 12 months of scheduled implant procedure.\n15. Myocardial Infarction (MI), percutaneous coronary intervention (PCI), or known unstable angina within the 60 days prior to the index procedure.\n16. Cerebro-Vascular Accident within the previous 3 months.\n17. Hemodynamic instability or on IV inotropes.\n18. Contraindication to anticoagulant therapy and dual antiplatelet therapy.\n19. Documented history of bleeding diathesis, hypercoagulable or active peptic ulcer or gastrointestinal bleeding within 3 months of scheduled implant procedure.\n20. Severe renal impairment or on dialysis.\n21. Any condition that, in the opinion of the investigator, may render the subject unable to complete the study (e.g. life expectancy \\\u003C 1 year), or lead to difficulties for subject compliance with study requirements.\n22. Acute anemia.\n23. Chronic Oral Steroid Use ≥ 6 months.\n24. Pregnant or lactating female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure.\n25. Pulmonary embolism within the last 6 months.\n26. Tricuspid Valve Tethering distance \\> 10 mm.\n27. Presence of transvalvular pacemaker or defibrillator leads which are determined as immobile or interfering with the procedure, as evaluated by echocardiography.\n28. Inadequate TEE acoustic window for appropriate visualization of the tricuspid valve that is required for guiding the index implant procedure.\n29. Contra-indicated for blood transfusion or refuses transfusion.\n30. Patient undergoing emergency treatment.\n31. Patient without appropriate jugular access.",{"count":105,"type":21},[24],"An early feasibility study to evaluate the safety and performance of 1) the transcatheter delivery and implantation of the Cardiac Implants (CI) annuloplasty ring and 2) the adjustment of the ring approximately 90 days following implantation in patients suffering from ≥ moderate functional tricuspid regurgitation (FTR).",[27],[135,136,137,138],"Tricuspid Valve","Annular Dilatation","Annuloplasty","Tricuspid Valve Repair","2021-11-18",{"date":141,"type":36},"2021-11-30",{"date":143,"type":21},"2021-12",{"date":145,"type":21},"2027-09",{"name":147,"class":43},"Cardiac Implants LLC",2]