[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Innoventric LTD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100532391","innoventric-trillium-stent-graft-early-feasibility-study-efs-100532391",false,"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","ALL","18 Years","85 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"NA","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).",[27,28],"Tricuspid Regurgitation","Tricuspid Regurgitation Functional",[30,31,27,32],"Tricuspid valve","Transcatheter","Tricuspid valve insufficiency","RECRUITING","2025-03-05",{"date":36,"type":37},"2025-03-07","ACTUAL",{"date":39,"type":37},"2024-08-05",{"date":41,"type":21},"2030-08",{"name":43,"class":44},"Innoventric LTD","INDUSTRY",12,""]