[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Micro Interventional Devices\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"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":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100569899","the-sttar-us-study-a-pivotal-study-of-transcatheter-tricuspid-annular-repair-in-the-us-100569899",false,"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%","ALL","18 Years",{"count":19,"type":20},600,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28],"Tricuspid Regurgitation Functional","Tricuspid Regurgitation","Severe Tricuspid Valve Regurgitation",[30,31,32],"MIA-T","severe TR","severe functional TR","NOT_YET_RECRUITING","2025-11-24",{"date":36,"type":37},"2025-11-26","ACTUAL",{"date":39,"type":20},"2025-12-31",{"date":41,"type":20},"2032-12",{"name":43,"class":44},"Micro Interventional Devices","INDUSTRY",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100338908","study-of-transcatheter-tricuspid-annular-repair-100338908","NCT03692598","Study of Transcatheter Tricuspid Annular Repair","STTAR","Inclusion Criteria:\n\n1. Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation (2-4)\n2. Age≥18 and ≤85 years old\n3. New York Heart Association (NYHA) Class II, III or ambulatory IV\n4. Left ventricular ejection fraction (LVEF) ≥30%\n5. Undergoing cardiac surgical procedure with the planned use of cardiopulmonary bypass (surgical arm only)\n6. Functional tricuspid valve regurgitation pathology with a structurally normal valve; and tricuspid valve annular diameter ≥ 40 mm (or 21 mm\u002Fm2) and ≤55 mm (or 29 mm\u002Fm2) or 2-4 + FTR\n7. Patient provides written Informed Consent before any study-specific tests or procedures are performed\n8. Patient is willing and able to comply with all specified study evaluations\n\nExclusion Criteria:\n\n1. Pregnant or lactating female\n2. Severe uncontrolled hypertension (SBP ≥ 180 mmHg and\u002For DBP ≥ 110 mmHg)\n3. Previous tricuspid valve repair or replacement\n4. Myocardial Infarction or known unstable angina within the 30-days prior to the index procedure\n5. Any PCI within 30 days prior to the index procedure or planned 3 months post the index procedure\n6. Life expectancy of less than 12-months\n7. Severe right heart dysfunction\n8. Pulmonary hypertension with PA mean 2\u002F3 rd MAP\n9. Active systemic infection\n10. Pericardial infection\n11. Any clinical evidence that the investigator feels would place the patient at increased risk with the deployment of the device\n12. Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. severe chronic obstructive pulmonary disease, hepatic failure, cardiac disease, autoimmune disorders or conditions of severe immunosuppression)\n13. Untreated coronary artery disease (CAD) requiring revascularisation unless CABG procedure is concomitant with MIA tricuspid annular repair (surgical arm only)\n14. Haemodynamic instability: systolic blood pressure \\\u003C90mmHg without reduction of afterload, shock, need for inotropic medication or IABP\n15. Active peptic ulcer or gastrointestinal (GI) bleeding in the past 3 months\n16. Cerebrovascular event within the past 6 months\n17. History of mitral\u002Ftricuspid endocarditis within the last 12 months\n18. Organic tricuspid disease\n19. Contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated\n20. Known alcohol or drug abuser\n21. Currently participating in the study of an investigational drug or device","85 Years",{"count":54,"type":20},60,[23],"The purpose of the study is to evaluate the safety and performance of the MIA Minimally Invasive Annuloplasty Device in patients with chronic functional tricuspid regurgitation.",[27],"RECRUITING","2024-10-21",{"date":61,"type":37},"2024-10-23",{"date":63,"type":37},"2016-12",{"date":65,"type":20},"2026-12",{"name":43,"class":44},6,""]