[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04905017":3,"trial-entities:NCT04905017":187,"trial-summary:NCT04905017":191},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":50,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":69,"eligibility_criteria":70,"std_ages":74,"locations":77,"central_contacts":176,"overall_officials":181,"references":185,"see_also_links":186},"NCT04905017","DMS-10809","Trisol System EFS Study","Early Feasibility Study of the Trisol System","RECRUITING","2031-07-01","2025-01","2025-11-21","2022-03-02","Trisol Medical","INDUSTRY",true,"The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).","A prospective, single-arm, open-label, multi-center early feasibility clinical study.",[19],"Tricuspid Regurgitation",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},30,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","Transcatheter Tricuspid Valve Replacement","Replacement of the tricusupid valve using Trisol System in a transcatheter approach",[34],"Treatment with the Trisol System",[36,40,44,47],{"measure":37,"description":38,"timeFrame":39},"Rate of device-related serious adverse events","Rate of device-related serious adverse events, including death (cardiovascular and non- cardiovascular), MI (MVARC definitions), disabling stroke, life-threatening bleeding (MVARC type III-V), renal failure requiring dialysis, emergency surgery, need for additional surgical procedures due to device failure","Up to 30 days",{"measure":41,"description":42,"timeFrame":43},"Rate of technical success","Technical success: delivery and deployment of the device in the correct position and retrieval of the delivery system.","During procedure",{"measure":45,"description":46,"timeFrame":39},"Rate of procedural success","Procedural success: freedom from emergency surgery or reintervention related to the device or access procedure, without death, stroke, or device dysfunction",{"measure":48,"description":49,"timeFrame":43},"Change in TR from baseline","Change in TR from baseline: reduction in TR grade immediately following implantation as compared to baseline TR grade, based on TEE imaging.",[51,55,59,63],{"measure":52,"description":53,"timeFrame":54},"Clinical performance endpoints - Change in TR from baseline","Change in TR from baseline: reduction in TR grade as compared to baseline TR grade, based on TTE imaging","At 30 days, 6 months, 12 months",{"measure":56,"description":57,"timeFrame":58},"Clinical performance endpoints - Change in NYHA class","New York Heart Association (NYHA) functional class: change in NYHA from baseline","At 30 days, 6 months, 12 months, and then annually",{"measure":60,"description":61,"timeFrame":62},"Clinical performance endpoints --minute walk test","Six-minute walk test: change in distance (m) from baseline","At 30 days, 6 months and 12 months",{"measure":64,"description":65,"timeFrame":62},"Quality-of-Life: change from baseline as measured by Kansas City Cardiomyopathy Questionnaire","Clinical performance endpoints -Quality-of-Life: change from baseline as measured by Kansas City Cardiomyopathy Questionnaire","ALL","18 Years",null,false,{"inclusion":71,"exclusion":72,"raw_text":73},[],[],"Inclusion Criteria:\n\n1. Age \\>18 years.\n2. Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.\n3. Participant has symptomatic, moderate or greater functional or degenerative tricuspid regurgitation (TR) as determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and\u002For transesophageal echocardiogram (TEE).\n4. New York Heart Association (NYHA) Functional Class II to IVa.\n5. Participant is deemed at high surgical risk or greater for tricuspid valve surgery and appropriate for transcatheter tricuspid valve replacement as determined by the local Heart Team.\n6. Participant adequately treated based upon medical standards, including for coronary artery disease, mitral regurgitation, and Guideline-Directed Medical Therapy (GDMT) for heart failure for at least 30-days prior to index procedure.\n7. Male or non-pregnant female.\n8. Participant understands the nature of the procedure and provides written informed consent prior to any study specific assessments.\n9. Participant is willing and able to comply with the specified study requirements and follow-up evaluations.\n10. Participant is anatomically suitable for the Trisol system, including trans-jugular access as per imaging requirements, and is approved by the Subject Screening Committee\n\nExclusion Criteria:\n\n1. Previous tricuspid valve repair or replacement which may impede proper study device delivery or deployment.\n2. Stroke or transient ischemic event within the previous 90 days.\n3. Acute myocardial infarction within the previous 90 days.\n4. Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices.\n5. Untreated clinically significant coronary artery disease requiring revascularization.\n6. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within the previous 30 days.\n7. New or untreated right heart chamber or\u002Fand superior vena cava intracardiac mass, thrombus, or vegetation.\n8. Systolic pulmonary arterial pressure (sPAP) \\> 80 mmHg as measured by pulmonary pressure catheter.\n9. Severe RV dysfunction with RV Stroke Work Index (RVSWI) g\u002Fm2\u002Fbeat \\\u003C400 and Pulmonary Artery Pulsatile index (PAPi) \\\u003C2.\n10. Ongoing sepsis, including active endocarditis.\n11. Active infection requiring current antibiotic therapy.\n12. Known bleeding diathesis or hypercoagulable state.\n13. Blood dyscrasias as defined: leukopenia (WBC \\\u003C3000 cells\u002Fmm3), thrombocytopenia (platelet count \\\u003C50,000 cells\u002Fmm3).\n14. Active gastrointestinal (GI) bleeding or history of GI bleed within the previous 60 days that would preclude anticoagulation.\n15. LVEF \\\u003C25% as measured by resting echocardiogram within 30 days prior to index procedure.\n16. Patients in whom transesophageal echocardiography is contraindicated.\n17. Aortic, mitral or pulmonary valve disease (severe stenosis or severe regurgitation) requiring intervention or performed within 90 days prior to enrollment.\n18. Severe tricuspid valve stenosis.\n19. Need for any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days prior to index procedure.\n20. Need for emergent or urgent non cardiac surgery for any reason.\n21. Contraindication or known allergy to device components, anticoagulation therapy with a vitamin K antagonist, or to contrast media that cannot be adequately premedicated.\n22. History of cardiac transplantation, or participant currently listed for urgent transplant (e.g., UNOS Status 1).\n23. Presence of any known life-threatening non-cardiac disease that will limit the subject's life expectancy to less than one year.\n24. Contraindication or known hypersensitivity to anticoagulant therapy and\u002For antiplatelet therapy.\n25. Venous anatomy unsuitable for implant delivery.\n26. Pacemaker or ICD lead present that would prevent appropriate valve placement.\n27. Active COVID-19 infection.\n28. Comorbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study.\n29. Previously enrolled in this study or currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.",[75,76],"ADULT","OLDER_ADULT",[78,91,109,121,132,148,163],{"facility":79,"status":8,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":88},"Cedars-Sinai Medical Center","Los Angeles","California","90048","United States",[85],{"name":86,"role":87},"Rajendra Makkar, MD","PRINCIPAL_INVESTIGATOR",{"lat":89,"lon":90},34.05223,-118.24368,{"facility":92,"status":8,"city":93,"state":94,"zip":95,"country":83,"contacts":96,"geoPoint":106},"Piedmont Heart Institute","Atlanta","Georgia","30309",[97,102,104],{"name":98,"role":99,"phone":100,"email":101},"Caryn Bernstein, MN FNP-BC CCRC","CONTACT","404.605.5688","caryn.bernstein@piedmont.org",{"name":103,"role":87},"Vinod Thourani, MD",{"name":105,"role":87},"Pradeep K Yadav, MD",{"lat":107,"lon":108},33.749,-84.38798,{"facility":110,"status":8,"city":111,"state":111,"zip":112,"country":83,"contacts":113,"geoPoint":118},"Columbia University Medical Center\u002FNYPH","New York","10032",[114],{"name":115,"role":99,"phone":116,"email":117},"Kate Dalton, MS, RD","347-514-3366","keb2114@cumc.columbia.edu",{"lat":119,"lon":120},40.71427,-74.00597,{"facility":122,"status":8,"city":123,"state":124,"zip":125,"country":83,"contacts":126,"geoPoint":129},"Cleveland Clinic","Cleveland","Ohio","44195",[127],{"name":128,"role":87},"Amar Krishnaswamy, MD",{"lat":130,"lon":131},41.4995,-81.69541,{"facility":133,"status":134,"city":135,"state":136,"zip":137,"country":83,"contacts":138,"geoPoint":145},"Main Line Health \u002F Lankenau Institute for Medical Research","NOT_YET_RECRUITING","Wynnewood","Pennsylvania","19096",[139,143],{"name":140,"role":99,"phone":141,"email":142},"Ann Marie Chikowski, MBA, RN, CCRC","484.476.8579","Chikowskia@MLHS.ORG",{"name":144,"role":87},"William Gray, MD FACC FSCAI",{"lat":146,"lon":147},40.00289,-75.27074,{"facility":149,"status":8,"city":150,"state":151,"zip":152,"country":83,"contacts":153,"geoPoint":160},"Vanderbilt University Medical Center","Nashville","Tennessee","37203",[154,158],{"name":155,"role":99,"phone":156,"email":157},"Natalie Jackson, MPH","615-343-1782","natalie.jackson@vumc.org",{"name":159,"role":87},"Kashish Goel, MD",{"lat":161,"lon":162},36.16589,-86.78444,{"facility":164,"status":8,"city":165,"state":166,"zip":167,"country":83,"contacts":168,"geoPoint":173},"University of Virginia Cardiology","Charlottesville","Virginia","22908",[169],{"name":170,"role":99,"phone":171,"email":172},"Linda Bailes Bryceland, RN","434-982-1058","SL9PC@virginia.edu",{"lat":174,"lon":175},38.02931,-78.47668,[177],{"name":178,"role":99,"phone":179,"email":180},"Ron Davidson, B. Sc., MBA","+972 528998866","rond@trisol-medical.com",[182],{"name":183,"affiliation":184,"role":87},"Isaac George, MD","Columbia University",[],[],{"nct_id":4,"conditions":188,"biomarkers":190},[189],"Tricuspid Valve Insufficiency",[],{"nct_id":4,"found":15,"summary":192,"prompt_version":202},{"design":193,"status":194,"heading":195,"summary":196,"follow_up":197,"word_count":198,"commitments":199,"compensation":200,"drugs_mentioned":201},"This is an early feasibility study, meaning it's an early look at the device. It's a single-arm, open-label study, which means all participants receive the Trisol System and everyone knows what treatment is being given. It plans to enroll 30 participants.","completed","Trisol System for Tricuspid Regurgitation","This study is testing the Trisol System, a device designed to replace the tricuspid valve (one of the heart's four valves) using a transcatheter approach (meaning it's inserted through a small tube, often in a blood vessel, rather than open-heart surgery). The goal is to learn about its safety and how well it performs in people with moderate or severe tricuspid regurgitation (TR), a condition where the tricuspid valve doesn't close properly, causing blood to leak backward. You might be able to join if you are over 18 and have symptomatic TR. The study will look at how often serious problems related to the device occur, and how successful the procedure is, both during the procedure and up to 30 days afterward. The study is currently unclear on its recruitment status and plans to enroll 30 participants.","The study measures outcomes up to 30 days after the procedure.",137,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]