[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-valve-insufficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-valve-insufficiency":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,42,75,99,127,155,181,212,237,259,290],{"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":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100341627","von-willebrand-factor-point-of-care-testing-to-improve-minimally-invasive-tavi-outcomes-100341627","NCT03728049","Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes","Point-of-care Haemostasis Testing of Von Willebrand Factor Function Embedded in Catheterization Laboratory to Improve Real-time Management of Paravalvular Regurgitation During Minimally Invasive TAVI","WITAVI-REAL","Inclusion Criteria:\n\n* All patients scheduled to undergo mini-invasive TAVI at any of the participating centers and fulfilling the inclusion criteria will be eligible for entry in the study. The decision to undertake TAVI will be made by the local heart team.\n* Symptomatic aortic stenosis scheduled to undergo TAVI\n* TAVI performed via mini-invasive approach defined as: transfemoral access route; local anesthesia\u002Fconscious sedation; no TEE guidance.\n* All types of prosthetic valves (balloon-expandable, self-expandable, others) are accepted\n\nExclusion Criteria:\n\n* TAVI through non-transfemoral approach\n* TAVI with concomitant percutaneous coronary intervention\n* TAVI performed under general anesthesia\n* TAVI performed under TEE guidance\n* Valve-in-valve procedure\n* Inability to provide informed consent\n* Associated ≥ moderate mitral regurgitation\n* Peri-procedural treatment with ticagrelor or prasugrel treatment \u002F direct oral anticoagulant","18 Years",{"count":52,"type":20},944,[23],"Paravalvular regurgitation (PVR) is an important complication of Transcatheter Aortic Valve Implantation (TAVI) that is associated with a 2.5-fold increase risk of mortality. Transesophageal echocardiographic (TEE) is considered as the gold standard to assess the severity of PVR and guide the physician to perform corrective procedures during TAVI, but it requires general anesthesia (GA). With such approach (TEE+GA), the PARTNERII trial has demonstrated that very low rate of PVR (3,5%) can be achieved with current devices. Registries have demonstrated a strong trend for using a mini-invasive approach in which the procedure is performed under conscious sedation (CS) without TEE. However, several studies raised concerns on the safety of this mini-invasive approach concerning the PVR rate. Thus, the accurate and real-time assessment of the presence and severity of PVR is an unmet clinical need to optimize TAVI without TEE guidance. A recent study reported that a blood biomarker reflecting the Von Willebrand factor (VWF) activity, i.e. the closure time with adenosine diphosphate (CT-ADP), is a valuable non-invasive, highly reproducible, and easy to perform alternative to TEE for PVR evaluation.\n\nThe hypothesis is that the measurement of CT-ADP during TAVI performed without TEE guidance can improve both the detection of significant PVR and thus the procedural and clinical outcomes (primary objective).",[56,27],"Aortic Valve Stenosis",[58,59,60,61,62,63],"Transcatheter Aortic Valve Replacement","Paravalvular regurgitation","Point-of-care test","Biomarker","Aortic stenosis","Von willebrand Factor","2026-05-20",{"date":66,"type":33},"2026-05-22",{"date":68,"type":33},"2019-12-18",{"date":70,"type":20},"2026-12",{"name":72,"class":73},"University Hospital, Lille","OTHER",9,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"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":84,"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",[26,27,28,88,89],"Aortic Valve Disease","Left Ventricular Dysfunction","2026-03-30",{"date":92,"type":33},"2026-04-01",{"date":94,"type":33},"2024-12-09",{"date":96,"type":20},"2027-08",{"name":39,"class":40},15,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":126},"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":109,"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],[26,114,115,116],"TAVR","SAVR","RCT","2026-03-06",{"date":119,"type":33},"2026-03-10",{"date":121,"type":33},"2026-03-05",{"date":123,"type":20},"2038-03",{"name":125,"class":73},"Second Affiliated Hospital, School of Medicine, Zhejiang University",12,{"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":138,"phases":4,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":154},"100349165","transpacific-tavr-registry-100349165","NCT03826264","Transpacific TAVR Registry","a Multinational Multicenter Prospective Transpacific TAVR Registry","TP-TAVR","Inclusion Criteria:\n\n* All patients undergoing TAVR\n* Informed consent","19 Years",{"count":137,"type":20},10000,"OBSERVATIONAL","This registry evaluates the long-term outcome of Transcatheter aortic valve replacement (TAVR) in real-world clinical practice.",[141,27],"Heart Valve Diseases",[114,143,144],"TAVI","real-world","2025-12-28",{"date":147,"type":33},"2026-01-02",{"date":149,"type":33},"2019-06-15",{"date":151,"type":20},"2036-12-31",{"name":153,"class":73},"Duk-Woo Park, MD",7,{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":21,"phases":164,"briefSummary":165,"conditions":166,"keywords":167,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":178,"locationsCount":180},"100452551","alliance-aviv-safety-and-effectiveness-of-the-sapien-x4-transcatheter-heart-valve-in-failing-aortic-bioprosthetic-valves-100452551","NCT05172973","ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves","Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves","Inclusion Criteria:\n\n1. Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and\u002For ≥ moderate insufficiency\n2. Bioprosthetic valve size suitable for SAPIEN X4 THV\n3. NYHA functional class ≥ II\n4. Heart Team agrees the subject is at high or greater surgical risk\n5. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system\n2. Failing valve has moderate or severe paravalvular regurgitation\n3. Failing valve is unstable, rocking, or not structurally intact\n4. Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient \\> 20 mmHg at the end of the index procedure for implantation of the original valve\n5. Increased risk of THV embolization\n6. Surgical or transcatheter valve in the mitral position\n7. Severe mitral regurgitation (\\> 3+) or ≥ moderate mitral stenosis\n8. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months\n9. Left ventricular ejection fraction \\\u003C 20%\n10. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation\n11. Increased risk of coronary artery obstruction after THV implantation\n12. Myocardial infarction within 30 days prior to the study procedure\n13. Hypertrophic cardiomyopathy with subvalvular obstruction\n14. Subjects with planned concomitant ablation for atrial fibrillation\n15. Clinically significant coronary artery disease requiring revascularization\n16. Any surgical or transcatheter procedure within 30 days prior to the study procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion.\n17. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure\n18. Endocarditis within 180 days prior to the study procedure\n19. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure\n20. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure\n21. Renal insufficiency and\u002For renal replacement therapy\n22. Leukopenia, anemia, thrombocytopenia\n23. Inability to tolerate or condition precluding treatment with antithrombotic therapy\n24. Hypercoagulable state or other condition that increases risk of thrombosis\n25. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication\n26. Subject refuses blood products\n27. Body mass index \\> 50 kg\u002Fm2\n28. Estimated life expectancy \\\u003C 24 months\n29. Female who is pregnant or lactating\n30. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments\n31. Participating in another investigational drug or device study that has not reached its primary endpoint\n32. Subject considered to be part of a vulnerable population",{"count":163,"type":20},200,[23],"The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.",[27,56],[168,169,170,171],"Transcatheter aortic valve replacement (TAVR)","Transcatheter aortic valve implantation (TAVI)","SAPIEN X4","Valve-in-valve","2025-12-18",{"date":174,"type":33},"2025-12-22",{"date":176,"type":33},"2023-11-22",{"date":37,"type":20},{"name":179,"class":40},"Edwards Lifesciences",35,{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":21,"phases":190,"briefSummary":191,"conditions":192,"keywords":195,"overallStatus":201,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":4},"100612290","comparison-of-early-postoperative-outcomes-between-minimally-invasive-valve-surgery-via-right-thoracotomy-and-conventional-valve-surgery-via-sternotomy-100612290","NCT07251660","Comparison of Early Postoperative Outcomes Between Minimally Invasive Valve Surgery Via Right Thoracotomy and Conventional Valve Surgery Via Sternotomy.","Comparison of Early Postoperative Outcomes Between Minimally Invasive Valve Surgery Via Right Thoracotomy and Conventional Valve Surgery Via Sternotomy","Inclusion Criteria:\n\n* Patients of any age and gender.\n* Undergoing elective, isolated mitral or aortic valve surgery.\n* Considered suitable for either:\n\n  * MIVS via right thoracotomy, or\n  * Conventional valve surgery , as decided by the operating surgical team.\n* Patients giving written informed consent.\n\nExclusion Criteria:\n\n* Emergency or redo cardiac surgeries\n* Concomitant cardiac procedures (e.g., CABG, multiple valve replacements)\n* Ejection Fraction \\\u003C30%\n* Severe pulmonary hypertension (identified as the mean pulmonary artery pressure (mPAP) exceeding 45 mmHg on echocardiography, as outlined by the AHA guidelines(10).\n* Active systemic infections or sepsis at the time of surgery\n* Refusal to participate in the study",{"count":189,"type":20},32,[23],"This randomized controlled trial aims to compare early postoperative outcomes between Minimally Invasive Valve Surgery (MIVS) via right thoracotomy and Conventional Valve Surgery via median sternotomy in patients undergoing elective, isolated mitral or aortic valve surgery. Minimally invasive techniques are believed to reduce postoperative pain, ventilation time, chest drain output, and wound complications, but evidence from Pakistan is limited.\n\nThe study will enroll patients of all ages and genders who are scheduled for isolated valvular procedures at Chaudhary Pervaiz Elahi Institute of Cardiology (CPEIC), Multan. Participants will be randomly assigned to undergo either minimally invasive thoracotomy or conventional sternotomy.\n\nPrimary outcomes include ventilation time, CPB duration, cross-clamp time, pain scores, and chest drain output. Secondary outcomes include wound healing (Day 7 and 30 days), return to routine activity, echocardiographic evaluation, transfusion requirements, and 30-day mortality. Findings from this study may provide evidence to guide the adoption of minimally invasive valvular surgery techniques in low-resource and developing settings.",[193,56,27,194],"Heart Valve Diseases or Prosthesis","Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)",[196,197,198,199,200],"Heart valve disease","Mitral valve surgery Aortic valve surgery Minimally invasive cardiac surgery","Conventional open-heart surgery","Aortic cross-clamping","Early postoperative outcomes","NOT_YET_RECRUITING","2025-11-19",{"date":204,"type":33},"2025-11-26",{"date":206,"type":20},"2025-12-15",{"date":208,"type":20},"2026-08-15",{"name":210,"class":211},"Chaudhry Pervaiz Elahi Institute of Cardiology","OTHER_GOV",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":17,"minAge":135,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":201,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":236},"100598218","korea-vhd-echo-study-surveillance-of-aortic-mitral--tricuspid-patients---insights-from-real-world-practice-100598218","NCT07068633","Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice","Inclusion Criteria:\n\n* Period: 2010.1.1\\~2020.12.31\n* Age \\> 18 years\n* Moderate or severe native VHD (AS, AR, MR and TR)\n* Perform echocardiography more than twice\n\nExclusion Criteria:\n\n* Poor image of echocardiography\n* Follow up loss",{"count":219,"type":20},30000,"Valvular heart disease (VHD) is a growing public health concern globally, with increasing disease burden and rising interest in advanced treatment strategies such as transcatheter interventions. However, there remains a significant lack of real-world data regarding echocardiography practices, disease prevalence and progression, referral patterns, and treatment pathways. Addressing these gaps is critical for improving patient care and informing clinical decision-making.\n\nSouth Korea provides a unique opportunity to conduct a nationwide retrospective echocardiographic study due to its advanced healthcare infrastructure, high patient volume, and strong tradition in clinical research. The current study aims to evaluate the real-world burden and clinical journey of patients with moderate or severe valvular disease over a 10-year period, based on echocardiographic and electronic medical record (EMR) data collected from multiple tertiary centers across the country.",[141,56,27,222,223,224,225,226],"Mitral Valve Insufficiency","Mitral Valve Prolapse","Tricuspid Valve Insufficiency","Rheumatic Heart Disease","Aortic Diseases","2025-07-07",{"date":229,"type":33},"2025-07-16",{"date":231,"type":20},"2025-08",{"date":233,"type":20},"2027-12-31",{"name":235,"class":73},"Yonsei University",1,{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":244,"targetDuration":246,"studyType":138,"phases":4,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":258},"100483259","avalus-european-registry---an-observational-study-to-evaluate-safety-and-efficacy-in-a-real-world-population-100483259","NCT05572710","Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population","Avalus","Inclusion Criteria:\n\n* Clinical indication for replacement of the native or prosthetic aortic valve with a bioprosthesis\n* Age \\>= 18 years\n* Patient has been adequately informed of risks and requirements of the registry (which are actually limited since the prosthesis is in full commercial use and only data registration is performed) and is able to provide informed consent for participation in the clinical registry.\n\nExclusion Criteria:\n\n* Patient requires salvage surgery (according to EuroSCORE II definitions: \"patients requiring cardiopulmonary resuscitation (external cardiac massage) en route to the operating theatre or prior to induction of anaesthesia. This does not include cardiopulmonary resuscitation following induction of anaesthesia\")\n* Not been able to provide informed consent",{"count":245,"type":20},1000,"1 Year","This is a prospective, observational, single-arm, multi-center registry of patients undergoing bioprosthetic aortic valve replacement with the Avalus valve. This prospective registry aims to examine the outcome and performance of surgical aortic valve replacement with the Avalus pericardial bioprosthesis.",[56,27],"2024-06-28",{"date":251,"type":33},"2024-07-01",{"date":253,"type":33},"2020-06-10",{"date":255,"type":20},"2025-12-31",{"name":257,"class":73},"Universitaire Ziekenhuizen KU Leuven",19,{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":268,"conditions":269,"keywords":278,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":236},"100534173","european-association-of-cardiovascular-imaging-multiple-and-mixed-valvular-disease-study-100534173","NCT06235385","European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study","EACVI-MMVD","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patient referred to the cardiovascular imaging department.\n3. Diagnosis of MMVD confirmed by transthoracic echocardiography, defined as:\n\n   1. Multiple VHD: at least 2 moderates to severe VHD involving ≥ 2 different valves, using the current ESC guidelines.\n\n      and\u002For\n   2. Mixed VHD: at least moderate stenosis and at least moderate regurgitation of a single valve, using the current ESC guidelines.\n4. Patient not refusing to have their data involved in the protocol after information.\n\nExclusion Criteria (patients fulfilling any of the following criteria are not eligible for inclusion in this study):\n\n1. History of prior valve surgery or percutaneous valve intervention (concerning a valve other than those involved in the definition of MMVD).\n2. Acute infective endocarditis at the time of evaluation for inclusion (confirmed according to modified Duke criteria) or history of endocarditis ≤ 6 months.\n3. Complex congenital heart diseases.",{"count":267,"type":20},1500,"This study aims to investigate the prevalence and characteristics of multiple and mixed valvular heart disease (MMVD), which includes combinations of stenotic or regurgitant lesions on cardiac valves. The research will be conducted as a multicenter observational study, involving several centers worldwide, and will have a one-year follow-up period (with a possible extension to 5 years). The primary aim is to determine the proportion of MMVD among patients evaluated for valvular heart disease. Secondary aims include the evaluation of the epidemiologic distribution of clinical, biological, and cardiovascular imaging characteristics at baseline, management strategies, and their impact on prognosis. The study will also evaluate clinical outcomes such as mortality, hospitalization for heart failure, and changes in echocardiographic parameters. This research aims to provide valuable insights into the diagnosis, management, and prognosis of MMVD, addressing an important knowledge gap in this area.",[141,270,88,56,27,271,272,273,222,274,275,224,276,277],"Multiple Valve Disease, Unspecified","Mitral Valve Disease","Mitral Valve Stenosis","Mitral Valve Insufficiency and Aortic Valve Insufficiency","Aortic Valve Stenosis With Insufficiency","Mitral Valve Disease Mixed","Tricuspid Valve Disease","Tricuspid Stenosis",[279,280],"Multiple Valvular Heart Disease","Mixed Valvular Heart Disease","2024-05-31",{"date":283,"type":33},"2024-06-03",{"date":285,"type":33},"2024-02-07",{"date":287,"type":20},"2029-08-01",{"name":289,"class":73},"Assistance Publique - Hôpitaux de Paris",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":17,"minAge":297,"maxAge":298,"enrollmentInfo":299,"targetDuration":4,"studyType":138,"phases":4,"briefSummary":301,"conditions":302,"keywords":303,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":236},"100374974","results-of-the-aortic-valve-reconstruction-in-children-100374974","NCT04162444","Results of the Aortic Valve Reconstruction in Children","Short-term and Midterm Results of the Aortic Valve Reconstruction With Autopericardium in Children","Inclusion Criteria:\n\n* Age from 29 days to 12 years\n* Patient's official caregivers have to sign the informed consent after they are thoroughly explained the meaning of the study, its protocol and timelines.\n* Patients with manifestations, with mean gradient at the aortic valve \\>40 mmHg with normal left ventricular ejection fraction (LVEF), or patients with manifestations with the mean gradient \\\u003C 40 mmHg with decreased LVEF, or patients with manifestations with severe aortic insufficiency, or patients without manifestations, but with decreased LVEF with aortic insufficiency, or patients with concomitant moderate aortic insufficiency and moderate aortic stenosis with manifestations.\n* Aortic Z-score over -1,5\n* Absence of subvalvular and supravalvular aortic stenosis\n* Absence of intracardiac malformations requiring correction, except for septal defects\n\nNon-inclusion criteria:\n\n* Known hypersensitivity to aspirin, heparin, nitinol, intravenous contrast or contradictions to their administration due to other causes.\n* Previous replacement of the aortic valve with mechanical or xenografts.\n* Confirmed active sepsis or endocarditis.\n* Hypoplasia of the fibrous ring of the aortic valve with Z score under -1,5.\n* Life expectancy less than 3 years due to concomitant diseases.\n* Participation in another clinical research.\n* Indications for urgent surgery.\n* Intracardiac malformations requiring momentary surgical correction.\n* Geographical instability of a patient and his\u002Fher official caregivers, complicating significantly the constant contact during the study\n\nExclusion Criteria:\n\n• Refusal of patient's caregivers to participate further in the study.","29 Days","12 Years",{"count":300,"type":20},40,"Aortic valve disease counts up to 5% of cases of congenital heart disease being one of the most common congenital malformations of the cardiovascular system. This disease requires replacement of the damaged valve which in itself is not a trivial task to complete in children as there is still no available best practice for valve replacement. Today, the following alternative variants are performed in children: mechanical aortic prosthesis, xenografts, allografts, and pulmonary autograft (Ross procedure) and each has its potential advantages and disadvantages.\n\nMechanical aortic prostheses require lifelong anticoagulation therapy and repeated surgeries to replace mechanical valves during child growth. Available xenografts in children also has suboptimal results not only because of absence of growth potential, but also due to development of degenerative changes in biological tissue of the graft leaflets. Allograft tissues are exposed to rapid biodegradation in the recipient body and thus requiring repeated surgeries associated with higher difficulty, high risk of hemorrhages, and injury of the coronary injuries. Ross procedure was proposed as theoretically the most evidence-based reconstruction of the aortic valve in children. Even successfully performed Ross operation transforms one-valve disorder into two-valve disease.\n\nThe accumulation of knowledge on the anatomy of the aortic root and improvement of surgical techniques led to the development of new methods for reconstruction of the valve function. The technique is widely applied in adult cardiac surgery, uses glutaraldehyde-treated autopericardium for augmentation of the leaflets. Absence of foreign material provides no need for anticoagulation therapy. Potentially, reconstruction of the aortic valve with autopericardium can be widely used in children.\n\nAim is to study safety, clinical and hemodynamic efficacy of the method of the aortic valve reconstruction with autopericardium in children with aortic valve disease. Patients aged 29 days to 12 years will be included into the study. The data according to the protocol of the study will be assessed at the stage of inclusion, during the surgery, in 30 days after the surgery, and in 1, 2, and 3 years after the surgery. Data about all the patients included into the research will be analyzed in order to study the endpoints and achieve the research aim.",[27],[304,305,306,307,308,309,310,311,312,313],"Aortic Valve Insufficiency\u002Fsurgery","Aortic Valve\u002Fsurgery","Child","Reconstructive Surgical Procedures\u002Fmethods","Cardiac Surgical Procedures","Hemodynamics","Pericardium\u002Ftransplantation","Transplantation, Autologous","Treatment Outcome","Heart Valve Prosthesis Implantation","2021-03-02",{"date":316,"type":33},"2021-03-03",{"date":318,"type":33},"2020-02-18",{"date":320,"type":20},"2027-10",{"name":322,"class":211},"National Medical Research Center for Children's Health, Russian Federation"]