[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"JenaValve Technology, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":101},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100562873","artist-aortic-regurgitation-trial-investigating-surgery-versus-trilogy-100562873",false,"NCT06608823","ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™","A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Transcatheter Heart Valve System Versus Surgical Valve Replacement in Patients With Aortic Regurgitation","ARTIST","Inclusion Criteria:\n\n1. Clinical indication for AVR for native valve predominant AR defined as:\n\n   1. Class I or II indication for AVR according to ACC\u002FAHA or ESC\u002FEACTS guidelines with moderate to severe or severe AR (Grade ≥3+) on transthoracic echocardiography, transesophageal echocardiography or cardiac MRI as assessed by the core laboratory OR\n   2. AR severity that remains indeterminate despite core laboratory review of all imaging including at least one advanced imaging modality (TEE or cardiac MRI) AND evidence of left ventricular damage\\* from AR with unanimous agreement from the local heart team, an independent clinical evaluation committee and the CRB that the symptomatic subject (NYHA II or greater) will benefit from SAVR for AR\n2. The subject is a candidate for TAVR using the Trilogy THV system and SAVR using a commercially approved bioprosthetic heart valve\n3. Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits\n4. Subject meets the legal minimum age to provide informed consent based on local regulatory requirements\n\nExclusion Criteria:\n\n1. Confirmed moderate (2+) or less AR severity by core laboratory evaluation\n2. Estimated life expectancy of less than 24 months due to associated non- cardiac comorbid conditions\n3. Subject is high-risk for SAVR as determined by the local heart team\n4. Subject refuses SAVR as a treatment option\n5. Subject refuses a blood transfusion\n6. Subject is selected for aortic valve repair or aortic surgery\n7. Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement\u002Fintervention\n8. Subject unable to undergo pre-procedure CT scan analysis for annular sizing\n9. Mitral or tricuspid disease, considered clinically significant, such that if randomized to surgery, repair or replacement would be expected.\n10. Subject has a known hypersensitivity or contraindication to all anticoagulation\u002Fantiplatelet medications (or inability to be anticoagulated for the index procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated\n11. Hostile chest or conditions or complications from a prior surgery that would preclude safe reoperation (i.e., mediastinitis, radiation damage, chest wall abnormalities, adhesion of aorta or internal mammary artery (IMA) to the sternum)\n12. Need for emergency surgery or TAVR for any reason\n13. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or need for mechanical circulatory support\n14. Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks\n15. Cardiac resynchronization therapy (CRT) device implantation within 30 days of randomization\n16. LVEF \\<25% according to core laboratory measurement of resting echocardiogram at time of screening\n17. Moderate to severe or worse right ventricular dysfunction on resting echocardiogram according to core laboratory\n18. Severe chronic liver disease (Child-Pugh C) or any active liver disease\n19. Chronic Kidney Disease Stage 4 or 5 (\\<30 cc\u002Fmin\u002F1.73 m2 or dialysis)\n20. Severe Pulmonary Hypertension (pulmonary arterial systolic pressure\n\n    * amp;amp;gt;2\u002F3 systemic systolic pressure)\n21. Severe Chronic Obstructive Pulmonary Disease (COPD) with FEV1\n\n    * amp;amp;lt;50% predicted or need for chronic supplementary oxygen\n22. Blood dyscrasia as defined: leukopenia (WBC \\<3,000 Cells\u002FμL), thrombocytopenia (platelet count \\<50,000 Cells\u002FμL), or anemia (hemoglobin \\<9.0 g\u002FdL) that is uncorrected prior to randomization\n23. History of bleeding diathesis or coagulopathy that is not adequately treated\n24. Active gastrointestinal bleeding precluding anticoagulation or antiplatelet therapy\n25. Any condition considered a contraindication to mechanical circulatory support\n26. Uncontrolled atrial fibrillation (i.e., resting heart rate \\>120 bpm)\n27. Evidence of an acute myocardial infarction ≤30 days before the index AVR\n28. Any percutaneous coronary or peripheral interventional procedure performed ≤30 days prior to AVR (Subjects with placement of coronary or peripheral stent(s) should be assessed for the ability to safely proceed with SAVR within the protocol timeframe)\n29. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization\n30. Prior stroke with residual modified Rankin Score ≥2\n31. Stroke or transient ischemic attack (TIA) within 6 months of randomization\n32. Body mass index (BMI) \\<20 or \\>50 kg\u002Fm2\n33. Currently participating in a cardiovascular investigational drug or device trial and has not yet completed follow-up for the primary endpoint (excluding registries)\n34. Severe cognitive decline (resulting in either inability to provide informed consent for the trial\u002Fprocedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)\n35. Other medical, social, or psychological conditions that in the opinion of the investigator preclude the subject from appropriate consent or adherence to the protocol required follow-up exams\n36. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements\n37. Anatomical exclusion criteria (ANY of the following):\n\n    1. Congenital bicuspid, unicuspid or quadricuspid aortic valve verified by echocardiography or CCT core laboratory\n    2. Native aortic annulus perimeter \\<66 mm or \\>90 mm per the core laboratory reading of baseline cardiac CT imaging\n    3. Iliofemoral arteries with vessel characteristics unsuitable for sheath passage (e.g., calcification, tortuosity) as determined by the case review board (CRB)\n    4. Significant abdominal or thoracic aortic disease (such as porcelain aorta, aneurysm, severe calcification, aortic coarctation) that would preclude safe passage of the delivery system or cannulation and aortotomy for SAVR\n    5. According to the CRB, a combination of aortic root angulation (angle between the plane of the aortic valve annulus and horizontal plane\u002Fvertebrae), sinus size, and straight length of the aorta that will not allow safe device delivery and THV deployment\n    6. Sinus of Valsalva anatomy that would prevent adequate coronary perfusion after valve implantation\n38. According to core laboratory evaluation, severe aortic stenosis\n39. Uncorrected hypertrophic obstructive cardiomyopathy\n40. Echocardiographic or Multi-slice CT (MSCT) evidence of untreated intracardiac mass or vegetation\n41. Left ventricular thrombus\n42. Left atrial thrombus without continuous appropriate anticoagulation within 90 days of the study procedure\n43. Complex coronary artery disease:\n\n    1. Unprotected left main coronary artery disease ≥50%\n    2. Syntax score \\>32 (in the absence of prior revascularization)\n    3. Heart Team determines that optimal revascularization cannot be adequately performed with EITHER CABG at the time of SAVR OR PCI at least 30 days prior to THV implant.","ALL",{"count":19,"type":20},1016,"ESTIMATED","INTERVENTIONAL",[23],"NA","To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System compared with surgical aortic valve replacement (SAVR) for treatment of subjects with clinically significant native aortic regurgitation (AR)",[26,27,28],"Aortic Regurgitation","Aortic Valve Insufficiency","Aortic Insufficiency","RECRUITING","2026-06-22",{"date":32,"type":33},"2026-06-25","ACTUAL",{"date":35,"type":33},"2025-06-18",{"date":37,"type":20},"2036-02",{"name":39,"class":40},"JenaValve Technology, Inc.","INDUSTRY",28,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100561787","the-jenavalve-align-ar-lvad-registry-100561787","NCT06594705","The JenaValve ALIGN-AR LVAD Registry","Transcatheter Aortic Valve Replacement Using the JenaValve TrilogyTM Heart Valve System for Clinically Significant Aortic Regurgitation in Patients With Left Ventricular Assist Devices (LVAD)","JENA-VAD","Inclusion Criteria:\n\n1. Subjects \\>=18 years of age with continuous flow LVAD (cfLVAD) with clinically significant AR1 leading to cfLVAD dysfunction using cfLVAD ASE guidelines that utilize contemporary management strategies for measurement of AR in patients with cfLVAD2,3:\n\n   • AR is graded from 0 to 6 (0 = none; 1 = trace; 2 = mild; 3 = mild-to-moderate; 4 = moderate; 5 = moderate-to-severe; 6 = severe). Considering that AR during continuous flow LVAD (cfLVAD) support is generally both systolic and diastolic, AR is deemed significant if graded ≥ 3.1\n2. Patient with NYHA functional class III\u002FIV\n3. Patient with high risk for SAVR as documented by Heart Team.\n4. Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy™ Heart Valve System\n5. Patient or the patient's legal representative has provided written informed consent\n6. Patient or the patient's legal representative agrees to comply with all required post-procedure follow-up visits\n\nExclusion Criteria:\n\n1. Congenital uni- or bicuspid (Sievers 0) aortic valve morphology\n2. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant\n3. Mitral regurgitation \\> moderate\n4. Clinically significant coronary artery disease (CAD) requiring revascularization within 30 days prior to index procedure, or planned CAD revascularization procedure within 12 months after index procedure\n5. Echocardiographic or CT evidence of left ventricular or aortic valve thrombus\n6. Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks\n7. Hypertrophic cardiomyopathy with or without obstruction\n8. Severe pulmonary hypertension (systolic PA pressure \\>80 mmHg)\n9. Decompensated right heart failure as assessed clinically and, if available, by baseline right heart catheterization hemodynamics (e.g., right atrial pressure \\> pulmonary capillary wedge pressure and cardiac index \\\u003C 2.5 L\u002Fmin\u002Fm2\n10. Severe RV dysfunction as assessed clinically and by echocardiography\n11. Aortic annular diameter of \\\u003C21.0 mm or \\> 28.6 mm (assessed by Multi-detector CT measurement)\n12. Aortic annulus angulation \\> 70° (assessed by Multi-detector CT measurement)\n13. Straight length of ascending aorta of \\\u003C 55 mm\n14. Significant disease of ascending aorta, including ascending aortic aneurysm (defined as maximal luminal diameter of 50 mm or greater) or atheroma (including if thick \\[\\>5 mm\\], protruding or ulcerated)\n15. Myocardial infarction \\\u003C 30 days prior to index procedure\n16. Cerebrovascular event (TIA, stroke) \\\u003C 180 days prior to index procedure\n17. Blood dyscrasias as defined: leukopenia (WBC \\\u003C 3000\u002Fmm³), or thrombocytopenia (platelets \\\u003C 90,000\u002Fμl) or anemia (Men: Hgb \\\u003C 8.1 g\u002Fdl; Women: Hgb \\\u003C 7.4 g\u002Fdl)\n18. Active peptic ulcer or upper gastrointestinal bleeding \\\u003C 90 days prior to index procedure\n19. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be premedicated\n20. Subject unable to undergo pre-procedure transesophageal echocardiography or Multi-Detector CT (MDCT) scan for aortic annular sizing\n21. Patient is enrolled in another investigational medical device or drug study which has not completed the required primary endpoint follow-up. (Note: Patients involved in a long-term surveillance phase of another study are eligible for enrollment in this registry)","18 Years",{"count":52,"type":20},50,[23],"To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) who are indicated for TAVR",[26,27,28,56,57],"Aortic Valve Disease","Left Ventricular Dysfunction","2026-03-30",{"date":60,"type":33},"2026-04-01",{"date":62,"type":33},"2024-12-09",{"date":64,"type":20},"2027-08",{"name":39,"class":40},15,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":75,"targetDuration":77,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":89,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":5},"100480463","tavis-registry---trilogy-heart-valve-system-for-management-of-patients-with-aortic-valve-disease-100480463","NCT05536310","TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease","Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease: Patient Registry and Post-Market Clinical Follow-up Study","TAVIS","Inclusion Criteria:\n\n1. Patients who have signed ICF and are indicated by their doctors to be treated with Trilogy Heart Valve System in line with the medical standard of care\n2. Patients with symptomatic severe aortic regurgitation (AR) or symptomatic, severe aortic stenosis (AS), who are at high risk for SAVR as documented by the heart team and Heart Team agrees that patient can undergo SAVR for \"bail out\"\u002Fto address unfavorable circumstances if necessary\n3. Patients 18 years of age or older\n4. Patient is willing to participate in the study, provides signed Informed Consent\u002FData Authorization Form and authorizes the sharing of data in the study\n5. The subject and treating physician agree the subject will return for all required post-procedure follow-up visits\n\nExclusion Criteria:\n\n1. Patients who have known hypersensitivity or contraindication to Nitinol (titanium and\u002For nickel), an anti-coagulation\u002Fanti-platelet regimen or contrast medium that cannot be managed with premedication\n2. Patients who have active bacterial endocarditis or other active infections\n3. Pediatric (\\\u003C18 years) and\u002For pregnant\u002Fnursing patients\n4. Congenital\u002Ffunctional unicuspid, bicuspid or quadricuspid native aortic valve morphology\n5. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant\n6. Echocardiographic evidence of current left heart thrombus\n7. Hypertrophic cardiomyopathy with or without obstruction.\n8. Access vessel characteristics that would preclude safe placement of the JenaValve 20Fr introducer sheath, such as severe obstructive calcification, severe tortuosity, or vessel diameter \\\u003C7mm.",{"count":76,"type":20},600,"5 Years","OBSERVATIONAL","To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).",[81,82,83,84,56,85,86,87,88],"Aortic Valve Stenosis","Aortic Valve Regurgitation","Aortic Valve Stenosis With Insufficiency","Constriction, Pathologic","Heart Valve Diseases","Cardiovascular Diseases in Old Age","Ventricular Outflow Obstruction","Aortic Stenosis, Severe",[90,56,91,82],"Trilogy","Transcatheter aortic valve replacement (TAVR)","NOT_YET_RECRUITING","2023-01-10",{"date":95,"type":33},"2023-01-11",{"date":97,"type":20},"2023-03",{"date":99,"type":20},"2027-10",{"name":39,"class":40},""]