[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tau-MEDICAL Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":50,"acronym":4,"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":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"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":53,"type":21},7,[24],"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.",[57],"Tricuspid Regurgitation (TR)",[59,60],"Pivot Extend","TauMedical","2025-04-10",{"date":63,"type":36},"2025-04-11",{"date":65,"type":21},"2025-05",{"date":67,"type":21},"2026-12",{"name":42,"class":43},3,""]