[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"severe-tricuspid-valve-regurgitation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:severe-tricuspid-valve-regurgitation":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100502304","patients-with-severe-tricuspid-regurgitation-after-tricvalve-system-implantation-100502304",false,"NCT05820516","Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation","Cardiovascular, Renal and haemodynamIc Outcomes in Patients With Severe TrIcuspid Regurgitation After triCvALve System Implantation: an International Registry - CRITICAL INTERNATIONAL REGISTRY","CRITICAL","Inclusion Criteria\n\n1. The subject must be 18 years of age or older\n2. The subject must be a patient with massive or torrential symptomatic tricuspid regurgitation demonstrated by echocardiography with significant backflow in the IVC and\u002For SVC and with a v-wave ≥ 25 mmHg as demonstrated by right heart catheterization (measured in the IVC and\u002For SVC 2-4 cm above\u002F below right atrium (RA) inflow) within 8 weeks prior to the implantation\n3. Suitable for TricValve Transcatheter Bicaval Valves System implantation according to anatomic criteria by computed tomography (CT)inserire la parte retrospettiva ossia i pazienti che già hanno avuto l'impianto\n4. The subjects must have severe, tricuspid regurgitation leading to New York Heart Association (NYHA) class III or IV\n5. Distance covered in 6-minute walk test (6MWT) ≥ 60m\n6. Patient\u002Fauthorized legal guardian understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent Patient\u002Fpatient's authorized legal guardian is geographically stable (or willing to return for required study follow-up) and understands and is willing to fulfil all of the expected requirements of the clinical protocol\n\nExclusion Criteria\n\n1. Known significant intracardiac shunt (e.g. ventricular septal defect) or congenital structural heart disease based on heart team decision\n2. Requirement for other elective cardiac procedures e.g. Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG) up to 90 days after the procedure or 30 days before the procedure\n3. Right ventricular failure (TAPSE ≤13 mm)\n4. Systolic pulmonary arterial pressure \\> 65 mmHg as assessed by Doppler echocardiography\n5. Life expectancy less than one year\n6. Cerebro-vascular event within the past 3 months\n7. History of mitral\u002Ftricuspid endocarditis within the last 12 months\n8. Patient has untreated significant left sided valvular heart disease which requires treatment (e.g. mitral regurgitation or stenosis, and aortic regurgitation or stenosis)\n9. Documented primary coagulopathy or platelet disorder, including thrombocytopenia (absolute platelet count \\\u003C90k)\n10. Documented evidence of significant renal dysfunction (serum creatinine \\> 3.0mg\u002Fdl) or on any form of dialysis at time of screening within the last 4 weeks\n11. Contraindication or known allergy to device's components, anti-coagulation therapy with vitamin K antagonists or contrast media that cannot be adequately pre-treated\n12. Evidence of an acute myocardial infarction (AMI) ≤ 1 month (30 days)\n13. Currently participating in another study of an investigational drug or device that would directly impact the treatment or outcome of the current study","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","3 Years","OBSERVATIONAL","International Registry to collect patients with severe TR undergoing TricValve implantation from multiple Italian and European centers, aimed at:\n\n* Assessing the effect of TricValve implantation on cardiovascular and all-cause mortality, HF rehospitalization, renal function, functional capacity and quality of life.\n* Clarifying the haemodynamic effects of TricValve implantation and investigating their pathophysiological implications.",[26],"Severe Tricuspid Valve Regurgitation",[26,28],"TricValve","RECRUITING","2026-05-06",{"date":32,"type":33},"2026-05-11","ACTUAL",{"date":35,"type":33},"2025-02-01",{"date":37,"type":21},"2027-05",{"name":39,"class":40},"Azienda Ospedaliero, Universitaria Pisana","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"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":50,"type":21},600,"INTERVENTIONAL",[53],"NA","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.",[56,57,26],"Tricuspid Regurgitation Functional","Tricuspid Regurgitation",[59,60,61],"MIA-T","severe TR","severe functional TR","NOT_YET_RECRUITING","2025-11-24",{"date":65,"type":33},"2025-11-26",{"date":67,"type":21},"2025-12-31",{"date":69,"type":21},"2032-12",{"name":71,"class":72},"Micro Interventional Devices","INDUSTRY"]