[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-regurgitation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-regurgitation":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,42,71,104,127,155,176,194,225,246,263,281,306],{"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":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":52,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100638048","active-post-market-surveillance-of-innovative-devices-for-valvular-heart-disease-100638048","NCT07605624","Active Post-Market Surveillance of Innovative Devices for Valvular Heart Disease","An Active Post-Market Surveillance Study Assessing the Real-World Clinical Applicability, Long-Term Safety, and Effectiveness of Innovative Medical Devices for Valvular Heart Disease","Inclusion Criteria:\n\n* Patients with valvular heart disease (VHD) receiving treatment with prosthetic aortic valve replacement systems (transcatheter and surgical valves), transcatheter mitral valve edge-to-edge repair (TEER) systems, or transcatheter tricuspid valve annuloplasty systems\n* Age ≥ 18 years\n* Patients who voluntarily participate in the study and sign the informed consent form\n* Willing and able to comply with follow-up requirements","18 Years",{"count":51,"type":20},5500,"1 Year","OBSERVATIONAL","This prospective, multicenter, observational cohort study aims to establish a post-market registry framework to evaluate the real-world clinical applicability, long-term safety, and effectiveness of innovative heart valve devices in China.",[56,26,57,58],"Aortic Stenosis","Mitral Regurgitation","Tricuspid Regurgitation","NOT_YET_RECRUITING","2026-05-18",{"date":62,"type":33},"2026-05-26",{"date":64,"type":20},"2026-05-10",{"date":66,"type":20},"2029-01-31",{"name":68,"class":69},"Beijing Anzhen Hospital","OTHER",1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":81,"conditions":82,"keywords":87,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":70},"100608144","delineate-prospective-100608144","NCT07197736","DELINEATE-Prospective","Deep Learning for Echo Analysis, Tracking, and Evaluation Prospective Evaluation (DELINEATE-Prospective)","DELINEATE","Inclusion Criteria:\n\n* Attending cardiologist employed by Columbia University, ColumbiaDoctors, or NewYork Presbyterian Hospital who reads transthoracic echocardiograms in the Columbia echocardiography laboratory\n* Provided informed consent to take part in the questionnaires or pivotal study\n\nExclusion Criteria:\n\n* Physician in training (cardiology fellow or advanced imaging fellow)",{"count":80,"type":20},50,"Heart disease is the leading cause of death in the United States, and echocardiography (or \"echo\") is the most common way doctors look at the heart. Echo is safe, painless, and can detect major heart problems, including weak heart pumping and valve disease.\n\nValve disease, especially aortic stenosis (narrowing) and mitral regurgitation (leakage), is common in older adults but often goes undiagnosed. While echo is the main tool for finding valve problems, it takes time, requires expert training, and results can vary between readers.\n\nRecent advances in artificial intelligence (AI), especially deep learning (DL), have shown promise in automatically analyzing heart images. However, past research hasn't fully tackled key echo techniques-like color Doppler and spectral Doppler-that are crucial for measuring how blood moves through heart valves. AI tools also face challenges in being used in everyday medical practice because of workflow issues, lack of real-world testing, and concerns about how the algorithms make decisions.\n\nAt Columbia University Irving Medical Center, researchers have built a large database of heart tests over the last six years and developed AI programs to analyze echocardiograms. The current study will test whether providing AI analysis to cardiologists in real time during echo reading can make the process faster and more consistent.",[83,84,56,85,86,26],"Valve Disease, Aortic","Mitral Regurgitation (MR)","Valvular Heart Disease","Tricuspid Regurgitation (TR)",[88,89,90,91,92,93,94],"artificial intelligence","deep learning","valvular heart disease","echocardiography","cardiovascular disease","mitral regurgitation","aortic stenosis","2026-04-14",{"date":97,"type":33},"2026-04-16",{"date":99,"type":20},"2026-04-15",{"date":101,"type":20},"2028-10-01",{"name":103,"class":69},"Columbia University",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},"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)",{"count":80,"type":20},[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",[26,27,28,116,117],"Aortic Valve Disease","Left Ventricular Dysfunction","2026-03-30",{"date":120,"type":33},"2026-04-01",{"date":122,"type":33},"2024-12-09",{"date":124,"type":20},"2027-08",{"name":39,"class":40},15,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":135,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":154},"100627805","art-trial-transcatheter-j-valve-versus-surgery-for-aortic-regurgitation-therapy-100627805","NCT07453407","ART Trial: Transcatheter J-VALVE Versus Surgery for Aortic Regurgitation Therapy","J-VALVE Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement for Patients With Aortic Regurgitation Therapy","ART","Inclusion Criteria:\n\n* 1\\) Age ≥65 years；\n* 2\\) a. Symptomatic patients with severe AR b. Asymptomatic patients with severe AR and evidence of LV function impairment (per current ESC \u002F ACC guidelines) Any of the following perimeters\n\n  1. LVEF ≤55%\n  2. LVESD \\>50 mm\n  3. LVESDi \\>22 mm\u002Fm2\n  4. LVESVi \\>45 mL\u002Fm2\n  5. normal LV systolic function at rest (LVEF \\>55%), and a progressive decline in LVEF on at least 3 serial studies to the low-normal range (LVEF 55% to 60%) or a progressive increase in LV dilation into the severe range (LV end-diastolic dimension \\[LVEDD\\] \\>65 mm),\n* 3\\) Evaluated by a multi-disciplinary heart team to be suitable for both surgery and transcatheter valve replacement\n* 4\\) Informed of the nature of the study, agrees to its provisions, has provided written informed consent, and agrees to comply with all required post-procedure follow-up visits\n\nExclusion Criteria:\n\n* 1\\. Confirmed moderate or less AR severity (Grade≤2+) by core laboratory evaluation\n* 2\\. Moderate or severe aortic valve stenosis\n* 3\\. Mixed with clinical relevant severe mitral or tricuspid disease that require valve intervention\n* 4\\. Pre-existing mechanical or bioprosthetic valve in any position. (of note, mitral ring is not an exclusion)\n* 5\\. Subject is high-risk for SAVR as determined by the local heart team\n* 6\\. Subject refuses SAVR as a treatment option\n* 7\\. Subject is selected for aortic valve repair or aortic surgery\n* 8\\. Need for emergency surgery or TAVR for any reason\n* 9\\. Anatomical exclusion criteria (ANY of the following):\n\n  1. Aortic Annulus Perimeter \\\u003C53 mm or \\>94 mm measured by CT\n  2. Maximal ascending aortic diameter ≥50 mm\n  3. Congenital aortic valve disease including unicuspid, bicuspid, or quadricuspid aortic valve anatomy\n  4. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (e.g., calcification, tortuosity).\n  5. Significant abdominal or thoracic aortic disease (such as porcelain aorta, severe calcification, aortic coarctation, etc.) that preclude safe passage of the delivery system or cannulation and aortotomy for surgical AVR.\n* 10\\. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit\n* 11\\. Cardiac resynchronization therapy (CRT) device implantation within 30 days of the screening visit\n* 12\\. Any condition considered a contraindication to mechanical circulatory support\n* 13\\. Hostile chest or conditions or complications from prior surgery that preclude safe reoperation (e.g., mediastinitis, radiation damage, abnormal chest wall, adhesion of aorta or IMA to sternum, etc.)\n* 14\\. Subject refuses blood transfusion\n* 15\\. Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement\u002Fintervention\n* 16\\. Evidence of acute myocardial infarction within 30 days of the screening visit\n* 17\\. Any percutaneous coronary or peripheral interventional procedure performed within 30 days of the screening visit (Subjects with placement of coronary or peripheral stent(s) should be assessed for the ability to safely proceed with SAVR within the protocol timeframe)\n* 18\\. Complex coronary artery disease (one of the following):\n\n  1. Unprotected left main coronary artery disease ≥50%\n  2. True bifurcation lesion (Medina: 1.1.1) and the diameter of the branch vessels is \\>2.5 mm\n  3. Chronic total occlusion (CTO)\n  4. Long lesion, expected stent length \\>38 mm\n  5. Multivessel lesion (at least 2 coronary arteries require interventional treatment)\n  6. Need to use multiple stents (planned \\> 3 stents)\n  7. Lesion with in-stent restenosis\n  8. Severe calcification lesion\n  9. Coronary ostial lesion\n  10. Heart Team assessment that optimal revascularization cannot be performed with either CABG at the time of SAVR or PCI at the time of TAVR.\n* 19\\. Symptomatic carotid or vertebral artery disease or carotid intervention within 30 days of the screening visit\n* 20\\. Stroke or transient ischemic attack (TIA) within 90 days of the screening visit\n* 21\\. Severe left ventricular dysfunction, defined as a resting left ventricular ejection fraction \\\u003C25%; or left ventricular end-systolic diameter (LVESD) \\>70 mm; or the presence of an artificial heart or left ventricular assist device; or being listed for heart transplantation or status post heart transplantation.\n* 22\\. Moderate to severe or worse right ventricular dysfunction on resting echocardiogram according to core laboratory\n* 23\\. Cardiac imaging (echocardiography, CT, and\u002For MRI) evidence of intracardiac mass, thrombus or vegetation\n* 24\\. Left atrial thrombus without continuous appropriate anticoagulation within 90 days of the study procedure\n* 25\\. Uncontrolled atrial fibrillation (i.e., resting heart rate \\>120 bpm)\n* 26\\. Hemodynamically significant hypertrophic Obstructive cardiomyopathy (HOCM), Peak LVOT gradient ≥50mmHg (resting or provoked) ESC 2022\u002F ACC 2020\n* 27\\. Untread Leukopenia (WBC\\\u003C3.0\\*109\u002FL), Untread Thrombocytopenia (Platelet count \\\u003C50\\*109), history of bleeding diathesis or coagulopathy, or hypercoagulable states, Acute posthemorrhagic anemia (hemoglobin \\\u003C9.0 g\u002FdL)\n* 28\\. Severe chronic obstructive pulmonary disease (COPD) (FEV1 \\\u003C50% predicted) or currently on home oxygen\n* 29\\. Severe pulmonary hypertension (e.g., PA systolic pressure ≥2\u002F3 systemic pressure)\n* 30\\. Severe chronic liver disease (Child-Pugh C) or any active liver disease\n* 31\\. Renal insufficiency (eGFR\\\u003C30mL\u002Fmin\u002F1.73m²) and\u002For requiring chronic peritoneal dialysis at the time of screening and\u002For requiring chronic hemodialysis at the time of screening\n* 32\\. Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks\n* 33\\. Subject has a known hypersensitivity or contraindication to all anticoagulation\u002Fantiplatelet medications (or inability to be anticoagulated for the index procedure), implant-related materials, or sensitivity to contrast media which cannot be adequately pre-medicated\n* 34\\. Inability to tolerate anti-thrombotic\u002Fanticoagulation therapy during or after the valve implant procedure\n* 35\\. Active gastrointestinal bleeding precluding anticoagulation or antiplatelet therapy\n* 36\\. BMI \\>50 kg\u002Fm2 or \\\u003C18.5 kg\u002Fm2\n* 37\\. Estimated life expectancy \\\u003C24 months due to associated non- cardiac comorbid conditions\n* 38\\. Immobility that would prevent completion of study procedures\n* 39\\. Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. Observational studies are not considered exclusionary\n* 40\\. 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)\n* 41\\. Pregnancy or intent to become pregnant (women suspected of becoming pregnant must have a negative serum or urine test for human chorionic gonadotropin before being included in the study)\n* 42\\. Other patients considered unsuitable for this clinical study by the investigator","65 Years",{"count":137,"type":20},1250,[23],"The overall purpose of ART trial is to establish the Safety and Efficacy of the J-VALVE Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement in Patients with Grade≥3+ Native Aortic Regurgitation.",[26,27,28],[26,142,143,144],"TAVR","SAVR","RCT","2026-03-06",{"date":147,"type":33},"2026-03-10",{"date":149,"type":33},"2026-03-05",{"date":151,"type":20},"2038-03",{"name":153,"class":69},"Second Affiliated Hospital, School of Medicine, Zhejiang University",12,{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":21,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":172,"leadSponsor":174,"locationsCount":4},"100628210","tavr-for-aortic-regurgitation-under-tte-guidance-100628210","NCT07458672","TAVR for Aortic Regurgitation Under TTE Guidance","Radiation- and Contrast-Free Transcatheter Aortic Valve Replacement for Aortic Regurgitation Under Transthoracic Echocardiography Guidance","Inclusion Criteria:\n\n* Age ≥18 years.\n* Severe native aortic regurgitation (AR) confirmed by echocardiography (per guideline-recommended multiparametric assessment).\n* Indication for intervention, defined as symptomatic severe AR (e.g., NYHA class II-IV) or asymptomatic severe AR with evidence of LV decompensation (e.g., reduced LVEF and\u002For LV dilation per guideline thresholds).\n* Deemed appropriate for transfemoral TAVR by a multidisciplinary Heart Team (e.g., elevated\u002Fprohibitive surgical risk or other clinical\u002Fanatomic factors favoring transcatheter therapy).\n\nExclusion Criteria:\n\n* Active infective endocarditis or ongoing systemic infection\u002Fsepsis.\n* Aortic pathology requiring open surgery, such as significant ascending aortic aneurysm\u002Froot disease above surgical thresholds, acute aortic syndrome, or other conditions where surgery is mandated.\n* Annulus\u002Flanding-zone dimensions outside device range",{"count":163,"type":20},30,[23],"Transcatheter aortic valve replacement (TAVR) is an established therapy for severe aortic valve disease, yet conventional workflows rely on fluoroscopy and iodinated contrast, exposing patients and operators to ionizing radiation and posing challenges for individuals with chronic kidney disease, contrast allergy, or other contraindications. In patients with native aortic regurgitation, the absence of annular\u002Fleaflet calcification and frequent annular dilation can further complicate device positioning and anchoring, increasing the procedural dependence on precise imaging guidance. Transthoracic echocardiography (TTE) provides real-time assessment of valve anatomy, coaxial alignment, depth control, and immediate hemodynamic results, and-when used as the primary imaging modality-offers a potential \"radiation- and contrast-free\" alternative for selected patients. However, clinical evidence for fully TTE-guided (echo-only) TAVR remains limited. Here, the investigators describe our procedural workflow and evaluate the feasibility and early outcomes of total TTE-guided TAVR for treating aortic regurgitation.",[26,167],"Transcatheter Aortic Valve Replacement (TAVR)","2026-03-04",{"date":170,"type":33},"2026-03-09",{"date":147,"type":20},{"date":173,"type":20},"2027-12-31",{"name":175,"class":69},"Chinese Academy of Medical Sciences, Fuwai Hospital",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":21,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":70},"100627839","tavr-for-aortic-regurgitation-under-tee-guidance-100627839","NCT07453849","TAVR for Aortic Regurgitation Under TEE Guidance","Radiation- and Contrast-Free TAVR for Aortic Regurgitation Under Transesophageal Echocardiography Guidance",{"count":163,"type":20},[23],"Under contemporary practice, transcatheter aortic valve replacement (TAVR) is typically performed with fluoroscopic visualization and repeated injections of iodinated contrast. While effective, this paradigm introduces cumulative radiation exposure to both patients and staff and can be problematic in individuals with renal dysfunction, prior contrast reactions, or other situations where contrast use is undesirable. Treating native aortic regurgitation (AR) adds another layer of complexity: limited valvular\u002Fannular calcification, enlarged annular dimensions, and dynamic root motion may reduce frictional \"purchase\" and make prosthesis stabilization more demanding, thereby heightening the need for continuous, high-fidelity intraprocedural imaging. Transesophageal echocardiography (TEE), with its close acoustic window to the aortic root, provides detailed real-time information on annular geometry, cusp coaptation, LVOT-aortic root alignment, guidewire trajectory, and implant depth, and it allows immediate confirmation of valve function and rapid recognition of adverse events (e.g., significant paravalvular regurgitation, maldeployment, pericardial effusion, or coronary compromise). Leveraging TEE as the dominant imaging modality therefore represents a pragmatic pathway toward a low-radiation and potentially contrast-sparing-or in selected cases, contrast-free-TAVR workflow. Nevertheless, evidence supporting an \"echo-only\" TEE-guided approach remains sparse, especially for native AR. In this study, we present a standardized TEE-guided procedural protocol and report feasibility and early clinical outcomes of TEE-only TAVR in patients with aortic regurgitation.",[26,186],"Transcatheter Aortic Valve Replacement","2026-03-02",{"date":145,"type":33},{"date":190,"type":20},"2026-03-01",{"date":192,"type":20},"2026-12-31",{"name":175,"class":69},{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":17,"minAge":202,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":21,"phases":205,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"100578960","phase-4-transcatheter-treatment-of-pure-aortic-regurgitation-with-vitaflow-liberty-system-100578960","NCT06818084","TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System","Transcatheter Treatment of Pure Aortic Regurgitation With VitaFlow Liberty System: a Prospective, Multicenter Study","TRAMPERS","Inclusion Criteria Age ≥ 60 years. Symptomatic moderate-to-severe or greater isolated aortic regurgitation.\n\nAsymptomatic moderate-to-severe or greater isolated aortic regurgitation meeting at least one of the following criteria:\n\nLVEF ≤ 55% (measured by biplane Simpson's method); LVESD \\> 50 mm ; LVESDi \\> 22 mm\u002Fmm²； LVESVi \\> 45mL\u002Fm2 Anatomical suitability for TAVR as assessed by the heart team. Provision of written informed consent by the patient or their legal guardian, with agreement to the treatment plan and willingness and ability to comply with all required follow-up assessments.\n\nExclusion Criteria Incomplete coronary revascularization. Less than 30 days of guideline-directed medical therapy at maximally tolerated doses.\n\nLife expectancy \\\u003C 1 year. LVEF \\\u003C 45%. eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m². Known allergy or contraindication to required medications (e.g., aspirin, clopidogrel, warfarin) or contrast media.\n\nAny condition that precludes contrast-enhanced CT. Concurrent moderate-to-severe or severe valvular heart disease other than aortic regurgitation.\n\nPoor patient compliance, unable to complete follow-up as required. Any other condition that, in the investigator's judgment, would make the patient unsuitable for the study.","60 Years",{"count":204,"type":20},120,[206],"PHASE4","This study is a prospective, multicenter, non-randomized controlled trial, planning to enroll 180 patients with pure native aortic regurgitation. On the basis of standardized medical therapy, patients will be assigned in a 1:1 ratio to undergo transfemoral transcatheter aortic valve replacement (TF-TAVR) . This prospective, multicenter trial aims to evaluate the safety and effectiveness of transfemoral TAVR using the VitaFlow™ self-expanding valve system compared to dedicated transcatheter devices in patients with PNAR.\n\nThe primary endpoint is a composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure, myocardial Infarction, and requiring dialysis or valve reoperation at 12 months post-procedure.\n\nSecondary endpoints include procedure-related complications, long-term clinical events, patient functional status and quality of life, bioprosthetic valve imaging follow-up, echocardiographic parameters, and treatment costs. All endpoint definitions conform to the Valve Academic Research Consortium-3 (VARC-3) criteria",[209,26,167],"AORTIC VALVE DISEASES",[211,212,213,214],"pure aortic regurgitation","Transcatheter aortic valve replacement (TAVR)","hypoattenuated leaflet thickening","reduced leaflet motion","2026-01-27",{"date":217,"type":33},"2026-01-30",{"date":219,"type":33},"2025-04-29",{"date":221,"type":20},"2027-11-30",{"name":223,"class":69},"Ruijin Hospital",4,{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":244,"locationsCount":70},"100372178","comparative-imaging-assessment-of-valvular-heart-disease-100372178","NCT04126018","Comparative Imaging Assessment of Valvular Heart Disease","Assessment of Left Ventricular Volumes and Strain and Assessment of Valvular Lesions Using Two- and Three-dimensional Echocardiography and Cardiac MRI, a Correlation Study","Inclusion Criteria:\n\n* Age 18-90 years of age\n* Suspected moderate or severe MR,AR or AS on the basis of prior known clinical history or clinical exam.\n* Suspected CRT \"non-responder\" with an implanted MRI compatible CRT device and reduced ejection fraction\n\nExclusion Criteria:\n\n* Acute traumatic cardiac injury\n* Aortic dissection or aortic root rupture\n* Congenital heart diseases such as patent ductus arteriosus, coarctation of aorta, ASD and VSD\n* Presence of A-V fistula or intracardiac shunts\n* Any contraindications to CMR\n* Moderate or severe dysfunction in multiple valves\n* Patients with significant claustrophobia","90 Years",{"count":234,"type":20},200,"The purpose of the study is to compare the various 2D and 3D methods of valvular heart disease quantification (Doppler, PISA, VCA, volumetric method) and strain with cardiac magnetic resonance (CMR) measurements of left and right ventricular systolic function strain and myocardial fibrosis assessment.",[237,56,26],"Valve Heart Disease","2026-01-12",{"date":240,"type":33},"2026-01-13",{"date":242,"type":33},"2019-08-23",{"date":173,"type":20},{"name":245,"class":69},"The Cleveland Clinic",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":232,"enrollmentInfo":252,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":70},"100576050","novel-characterization-of-sex-specific-biologic-signatures-in-valvular-heart-disease-100576050","NCT06780241","Novel Characterization of Sex Specific Biologic Signatures in Valvular Heart Disease","Inclusion Criteria:\n\n* Age 18-90 years of age\n* Suspected moderate or severe (2-3+ or more) aortic regurgitation, or moderate or more aortic stenosis on the basis of prior known clinical history, echocardiogram or cardiac MRI.\n\nExclusion Criteria:\n\n* Acute traumatic cardiac injury\n* Aortic dissection or aortic root rupture\n* Congenital heart diseases such as patent ductus arteriosus, coarctation of aorta, ASD and VSD\n* Presence of A-V fistula or intracardiac shunts\n* Any contraindications to cardiac MRI including:\n\n  * Patients with any MR-incompatible implant, including cardiac pacemakers or defibrillators, or older types of cerebral aneurysm clips.\n  * Patients who weigh more than 440 lbs. or have a very wide waist circumference.\n  * Patients with claustrophobia may have difficulty tolerating the exam.",{"count":234,"type":20},"This project aims to validate sex-specific biologic signatures associated with aortic valve disease developed in a large multicenter CMR registry, using unsupervised phenomapping.\n\nThe aim to use standard and advanced CMR techniques (MRF, DTI, chemical exchange transfer, and radiomics analysis) is to determine advanced CMR predictors of reverse remodeling following aortic valve surgery and develop sex-specific thresholds for risk. Infrastructure developed by this study will enable development of an innovative, scalable, sex-specific precision medicine cardiovascular imaging pipeline to determine overall risk and treatment response.",[26,57,56],"2025-12-28",{"date":257,"type":33},"2026-01-02",{"date":259,"type":33},"2024-12-10",{"date":261,"type":20},"2030-12-31",{"name":245,"class":69},{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":269,"enrollmentInfo":270,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":278,"leadSponsor":279,"locationsCount":70},"100601013","mild-and-moderate-aortic-regurgitation-risk-factors-for-progress-and-outcome-100601013","NCT07104968","Mild and Moderate Aortic Regurgitation: Risk Factors for Progress and Outcome","Inclusion Criteria:\n\n* Patients investigated with echocardiography between January 2003 and March 2025\n* Age ≥18 years\n* At least minimal aortic regurgitation\n* At least one additional echocardiography after the index investigation\n\nExclusion Criteria:\n\n* Age \\\u003C18 years","100 Years",{"count":271,"type":20},35000,"This observational study aims to evaluate risk factors of progress and adverse outcome of aortic regurgitation",[26],"2025-08-01",{"date":276,"type":33},"2025-08-05",{"date":274,"type":20},{"date":120,"type":20},{"name":280,"class":69},"Uppsala University",{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":17,"minAge":289,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":21,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":70},"100600457","early-feasibility-study-of-surgical-implantation-of-a-polymer-prosthetic-mitral-and-aortic-valve-100600457","NCT07097740","Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve","A Prospective Early Feasibility Clinical Study of Surgical Implantation of a Polymer Prosthetic Heart Valve","POLYVALVE-FIH","Inclusion Criteria:\n\n* Adults requiring surgical replacement of either mitral or aortic valve\n* Capable of undergoing cardiopulmonary bypass\n* Able to tolerate anticoagulation therapy\n* Able to understand study purpose, willing to provide informed consent and comply with follow-up\n\nExclusion Criteria:\n\n1. History of previous cardiac valve surgery or percutaneous valve replacement, including surgical aortic or mitral valve replacement (excluding Percutaneous Balloon Mitral Valvuloplasty \\[PBMV\\], which is permitted).\n2. Requirement for urgent or emergency cardiac surgery.\n3. Planned concurrent aortic valve surgery or combined valve procedure (e.g., simultaneous aortic and mitral valve surgery).\n4. Scheduled coronary artery bypass graft (CABG) during the same admission.\n5. Anticipated need for additional non-valve cardiac surgery within 12 months.\n6. Active systemic infection, including pneumonia or infective endocarditis.\n7. Intracardiac thrombus detected on echocardiography or imaging.\n8. Stroke or transient ischemic attack within the prior 3 months.\n9. Myocardial infarction, unstable coronary syndrome, or coronary revascularization within the prior 3 months.\n10. Severe comorbidities with expected life expectancy \\\u003C12 months, including Child-Pugh C liver disease, end-stage malignancy, or advanced pulmonary disease.\n11. Participation in another interventional clinical trial involving investigational devices or drugs.\n12. Anatomical risk factors such as ascending aortic aneurysm (≥50 mm), bicuspid aortic valve with ascending aorta ≥45 mm, or other high-risk features identified on imaging.\n13. Left ventricular ejection fraction (LVEF) ≤35%, indicating severe systolic dysfunction.\n14. Severe renal insufficiency, e.g., estimated GFR \\\u003C30 mL\u002Fmin\u002F1.73 m² or requirement for chronic dialysis.\n15. Coagulopathy or active bleeding disorders, e.g., INR \\>1.5 without anticoagulation therapy.\n16. Hematologic abnormalities: hematocrit \\\u003C30%, hemoglobin \\\u003C100 g\u002FL, platelet count \\\u003C100 × 10⁹\u002FL, or WBC \\\u003C4 × 10⁹\u002FL or \\>10 × 10⁹\u002FL.\n17. History of substance abuse, chronic alcoholism, or significant psychiatric illness impairing study compliance.\n18. Preoperative or intraoperative anatomical unsuitability of the valve apparatus or cardiac structure.\n19. Known allergy or hypersensitivity to polyurethane, polyester, or sulfonate-based biomaterials used in the valve prosthesis.\n20. Withdrawal from the study after valve implantation (such participants are not allowed to re-enroll).","50 Years",{"count":291,"type":20},10,[23],"The goal of this clinical trial is to explore the early feasibility, initial safety, and efficacy of surgical implantation of a polymer prosthetic heart valve in patients requiring either mitral valve replacement or aortic valve replacement.\n\nThe main question it aims to answer is:\n\n\\-- What is the rate of valve-related complications, including thromboembolism, valve thrombosis, severe perivalvular leak, severe bleeding, and endocarditis, at 12 months post-operation?\n\nParticipants will undergo:\n\n* Surgical implantation of a polymer prosthetic valve (mitral valve replacement for mitral valve group and aortic valve replacement for aortic valve group).\n* Regular follow-up visits at 30 days, 3-6 months, and 12 months post-operation to evaluate clinical outcomes, including echocardiographic assessment and clinical event monitoring.",[209,295,56,26,296,57],"Mitral Valve Disease","Mitral Stenosis","2025-07-24",{"date":299,"type":33},"2025-07-31",{"date":301,"type":33},"2025-06-27",{"date":303,"type":20},"2027-06",{"name":305,"class":40},"Mitrassist Lifesciences Limited Co., Ltd.",{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":21,"phases":315,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":327},"100523913","safety-and-effectiveness-of-taurustrio-heart-valve-system-in-patients-with-severe-aortic-regurgitation-ar-100523913","NCT06101888","Safety and Effectiveness of TaurusTrio™ Heart Valve System in Patients With Severe Aortic Regurgitation (AR)","A Prospective, Multicenter, Single-group Clinical Study to Evaluate the Safety and Efficacy of Peijia Medical Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Regurgitation","Inclusion Criteria:\n\n* Patients who voluntarily participate and sign the informed consent and are able to comply with the entire trial process;\n* Age ≥ 18 years;\n* Adult subjects with severe AR (Grade ≥ 3) as assessed by echocardiography based on ASE (American Society of Echocardiography) using multiparametric approach with:\n\n  * Jet width ≥ 65% of LVOT\n  * Vena contracta width of \\> 6 mm\n  * Holodiastolic flow reversal in proximal abdominal\u002Fdescending aorta\n  * Jet deceleration rate\u002FPressure half time \\\u003C200ms\n  * AND, For Grade 3:\n  * Regurgitant volume ≥ 45-59 ml\u002Fbeat\n  * Regurgitant fraction ≥ 40-49%\n  * EROA ≥ 0.2-0.29 cm2\n  * OR, For Grade 4:\n  * Regurgitant volume ≥ 60 ml\u002Fbeat\n  * Regurgitant fraction≥50%\n  * EROA ≥ 0.3 cm2 Note: In cases where not all criteria listed for severe AR are met, the Core Lab will determine severity. Supplemental CMR imaging may be used to substantiate the degree of AR reported by Core Lab on baseline echo when imaging is suboptimal, Doppler parameters are discordant or inconclusive regarding the severity of AR, or when a discrepancy is present between the echo findings and the clinical setting.\n* Patients who have symptoms obviously caused by Aortic Regurgitation, such as dyspnea, chest pain, NYHA Class II or higher;\n* Patients who are unsuitable for conventional surgery but needs TAVR（It is recommended to refer to the 2020 ACC\u002FAHA Heart Valve Disease Management Guidelines when evaluating the risks of surgical valve surgery），evaluated by the cardiac team (including at least one interventional cardiologist and one cardiovascular surgeon)\n* Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy™ Heart Valve System，evaluated by core laboratory;\n\nExclusion Criteria:\n\n* Congenital uni- or bicuspid aortic valve morphology；\n* Previous prosthetic aortic valve (bioprosthesis or mechanical) implant；\n* Mitral regurgitation or Tricuspid regurgitation\\> moderate；\n* 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；\n* Echocardiographic evidence of left ventricular thrombus；\n* Endocarditis within 180 days prior to index procedure；\n* Hypertrophic cardiomyopathy with or without obstruction；\n* Severe pulmonary hypertension (systolic PA pressure \\>80 mmHg)；\n* Severe RV dysfunction as assessed clinically and by echo；\n* Severely reduced left ventricular ejection fraction (LVEF \\\u003C25%)；\n* Aortic annular perimeter derived diameter of \\\u003C21.0 mm or \\> 28.6 mm or perimeter \\\u003C66.0 mm or \\>90 mm (assessed by Multi-Detector CT measurement)；\n* Aortic annulus angulation \\> 70° (assessed by Multi-Detector CT measurement)；\n* Straight length of ascending aorta of \\\u003C 55 mm；\n* 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)\n* Need for urgent or emergent TAVR procedure for any reason；\n* Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device within 30 days prior to index procedure；\n* Myocardial infarction \\\u003C 30 days prior to index procedure；\n* Cerebrovascular event (TIA, stroke) \\\u003C 180 days prior to index procedure；\n* Patients with common carotid artery or internal carotid artery or vertebral artery stenosis (\\>70%)；\n* Patients with severe coagulopathy；\n* Severe renal insufficiency (GFR \\\u003C 30 ml\u002Fmin) at Screening, OR renal disease requiring renal replacement therapy within 180 days prior to index procedure；\n* 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)；\n* Active peptic ulcer or upper gastrointestinal bleeding \\\u003C 90 days prior to index procedure；\n* Known allergies to to heparin, aspirin, ticlopidine, Clopidogrel, Nitroglycerin and other drugs，contrast agents, nitinol shape memory alloy, tantalum or porcine products；\n* Contraindication to intraoperative transesophageal echocardiography and\u002For Multi-Detector CT (MDCT) scan；\n* Estimated life-expectancy of \\\u003C 24 months；\n* 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 study);\n* Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the patient from providing appropriate informed consent;\n* Severe dementia (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 assessments);\n* Unable to comply with follow-up requirements;",{"count":314,"type":20},116,[23],"To evaluate the safety and effectiveness of the TaurusTrio™ Heart Valve System in a patient population with symptomatic severe AR requiring replacement\u002Frepair of their native aortic valve that are at high risk for open surgical aortic valve replacement\u002Frepair (SAVR).",[26],"2024-03-15",{"date":320,"type":33},"2024-03-18",{"date":322,"type":33},"2023-08-01",{"date":324,"type":20},"2029-07-31",{"name":326,"class":40},"Peijia Medical Technology (Suzhou) Co., Ltd.",19]