[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-valve-regurgitation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-valve-regurgitation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,48,74,99,127,165,190,214,246,273,293,321,343],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100551107","j-valve-transfemoral-pivotal-study-100551107",false,"NCT06455787","J-Valve Transfemoral Pivotal Study","J-Valve to Treat Aortic Regurgitation Via Transcatheter Therapy","JOURNEY","Inclusion Criteria:\n\n1. Symptomatic according to New York Heart Association (NYHA) functional class (FC) II or higher\n2. Severe AR, defined as follows, as assessed by Imaging Core Laboratory:\n\n   A. Severe AR by Transthoracic Echocardiography (TTE) (grade 3 or 4)\n\n   B. OR, if indeterminate AR, by TTE, ANY ONE of the following:\n\n   i. Cardiac magnetic resonance imaging (CMR)-derived aortic regurgitant fraction (RF) ≥43% ii. CMR-derived RF ≥33% + left ventricular dilation (left ventricular end diastolic volume index \\[LVEDVi\\]) \\>105 mL\u002Fm\\^2 for men or LVEDVi \\>96 mL\u002Fm\\^2 for women) iii. CMR-derived RF ≥33% + LV ejection fraction (LVEF) ≤55% or left ventricular end systolic volume index (LVESVi) ≥43mL\u002Fm\\^2; iv. Severe AR by Transesophageal Echocardiography (TEE) (grade 3 or 4)\n3. High risk for surgery as judged by a multi-disciplinary heart team\n4. Suitable anatomy to accommodate the insertion, delivery, and deployment of the study devices (see anatomic exclusions below)\n5. Written informed consent and agreement to comply with all required post-procedure follow-up visits at investigational site.\n\nExclusion Criteria:\n\n1. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant\n2. Aortic valve stenosis \\> moderate\\*\n3. Severe mitral valve or tricuspid valve regurgitation\\*\n4. Severe mitral valve or tricuspid valve stenosis\\*\n5. Active infection, including infective endocarditis\n6. Cardiac imaging evidence of cardiac mass, thrombus or vegetation\n7. Inability to tolerate or a condition precluding treatment with antithrombotic (antiplatelet, anticoagulant) therapy\n8. Renal insufficiency (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m\\^2) or end stage renal disease requiring chronic dialysis\n9. Liver disease (cirrhosis of the liver \\[Child-Pugh Class B or C\\])\n10. Blood dyscrasias as defined: leukopenia (WBC \\\u003C3000 cells\u002FmcL), thrombocytopenia (platelet count \\\u003C50,000 cells\u002FmcL), anemia (hemoglobin \\\u003C9 g\u002FdL), history of bleeding diathesis coagulopathy, or hypercoagulable state (unless therapeutically stable)\n11. Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, Nitinol (Nickel, Titanium) or sensitivity to contrast media, which cannot be adequately premedicated\n12. Left ventricular dysfunction with left ventricular ejection fraction (LVEF) \\\u003C25% as measured by resting echocardiogram (or by CMR, when performed)\\*\n13. Clinically significant untreated coronary artery disease requiring revascularization or anticipated coronary revascularization procedure within 12-months post index procedure\n14. Acute myocardial infarction within 30 days prior to index procedure\n15. PCI within 30 days prior to index procedure\n16. Carotid intervention within 6 weeks prior to index procedure or carotid artery disease requiring intervention\n17. Previous, or planned, other surgical or interventional procedures within 30 days before, during, or within 30 days after the index procedure\n18. Uncontrolled atrial fibrillation\n19. Severe right ventricular (RV) dysfunction\\*\n20. Pulmonary hypertension (systolic PA pressure \\>70mmHg or systolic PA pressure ≥2\u002F3 of systemic systolic BP)\n21. Severe chronic obstructive pulmonary disease (COPD) requiring chronic oral steroids or requiring continuous home O2\n22. Stroke (CVA), transient ischemic attack (TIA) or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to index procedure\n23. Cardiogenic shock defined as systolic blood pressure \\\u003C90 mmHg in addition to signs of tissue hypoperfusion or the need for vasopressors and\u002For mechanical hemodynamic support to maintain systolic blood pressure ≥90mmHg\n24. Patient requires mechanical circulatory support within 30 days prior to index procedure\n25. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions\n26. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements\n27. Participation in another investigational study that has not reached its primary endpoint\n28. Considered to be part of a vulnerable population\n\n    * As assessed by Imaging Core Laboratory\n\nAnatomic Exclusions:\n\n1. Ascending Aortic diameter \\>5 cm\\*\n2. Aortic Annulus Perimeter \\\u003C57 mm or \\>104 mm\\*\n3. Inappropriate anatomy for femoral introduction and delivery of the study system\n4. Left ventricular end-diastolic diameter (LVEDD) \\>75 mm\\*\n5. Congenital aortic valve disease including Unicuspid, Bicuspid, or Quadricuspid aortic valve anatomy\\*\n6. Congenital univentricle or other condition that, in the opinion of the investigator and\u002For consulting physician, may constitute an unwarranted surgical risk\n7. Excessive aortic valve prolapse that would preclude proper seating of the implant in the aortic annulus\n8. Abdominal\u002Fthoracic aortic aneurysm ≥5.0 cm\\*\n9. Aorto-iliac disease requiring intervention to facilitate delivery of access sheath\n10. Excessive tortuosity of delivery system pathway, defined as severe tortuosity of multiple vessels including iliofemoral, thoracoabdominal aorta, aortic arch, or LV-aortic root angle \\>80⁰\n11. Non-native anatomy in aortic zones 0A \\& 0B (aortic valve annulus to the distal margin of the right pulmonary artery); 0C (to innominate) only if deemed unfavorable by the Study Screening Committee\n\n    * As assessed by Imaging Core Laboratory","ALL","18 Years",{"count":20,"type":21},194,"ESTIMATED","INTERVENTIONAL",[24],"NA","The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR).\n\nA Cardiac Magnetic Resonance (CMR) sub-study will examine if intervention for AR translates to improved ventricular remodeling, the impact of LV remodeling on clinical outcomes and quality of life, as well as volumetric and myocardial differences between genders.",[27,28],"Aortic Valve Regurgitation","Aortic Valve Disease Mixed",[30,31,32,33,34],"J-Valve Transfemoral System","Transcatheter Therapy","Transcatheter Aortic Valve Replacement","TAVR","Transfemoral","RECRUITING","2026-04-30",{"date":38,"type":39},"2026-05-04","ACTUAL",{"date":41,"type":39},"2024-10-17",{"date":43,"type":21},"2032-02",{"name":45,"class":46},"JC Medical, Inc., an affiliate of Edwards Lifesciences LLC","INDUSTRY",40,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100474540","valve-hemodynamic-optimization-based-on-doppler-echocardiography-vs-catheterization-measurements-following-viv-tavr-100474540","NCT05459233","Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR","Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial","ECHOCATH","Inclusion Criteria:\n\n* Patients with surgical aortic bioprosthetic valve failure defined as severe aortic stenosis and\u002For regurgitation approved for a valve-in-valve procedure by the Heart Team\n* Surgical stented bioprosthetic valve (label size ≤25 mm)\n* TAVR with the SAPIEN 3 Ultra valve\n\nExclusion Criteria:\n\n* Stentless or sutureless surgical valves\n* Trifecta bioprosthesis\n* Hancock II bioprosthesis\n* High-risk of coronary obstruction (defined either as a virtual transcatheter valve - coronary distance as evaluated by CT \\\u003C4 mm or based on the criterion of the heart team responsible for the procedure).\n* Impossibility to obtain written informed consent",{"count":57,"type":21},310,[24],"Data on valve performance following ViV-TAVR has usually been obtained with the use of Doppler-echocardiography. However, some reports have shown significant discordances in the evaluation of mean transvalvular gradient between echocardiography and catheterization, with an overestimation of the real gradient with echo (vs. cath) in most cases. Thus, the incidence of procedural-device failure may be lower than that reported in the ViV-TAVR literature,",[61,27,62],"Aortic Valve Stenosis","Prosthesis Failure","2026-03-23",{"date":65,"type":39},"2026-03-24",{"date":67,"type":39},"2023-01-11",{"date":69,"type":21},"2029-09-01",{"name":71,"class":72},"Institut universitaire de cardiologie et de pneumologie de Québec, University Laval","OTHER",7,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":4},"100620888","journey-lvad-journey-left-ventricular-assist-device-100620888","NCT07363473","JOURNEY LVAD: JOURNEY Left Ventricular Assist Device","Transcatheter Therapy to Treat Aortic Regurgitation in the Presence of a Left Ventricular Assist Device","Inclusion Criteria:\n\n1. Adult with durable left ventricular assist device (LVAD) support and clinically significant AR (grade 4 or higher as assessed by core lab using TTE and adjunct TEE, if necessary) leading to LVAD dysfunction\n2. Symptomatic according to New York Heart Association (NYHA) functional class II or higher\n3. High risk for surgery as judged by a multi-disciplinary heart team\n4. Suitable anatomy to accommodate the insertion, delivery, and deployment of the study devices (see anatomic exclusions below)\n5. Written informed consent and agreement to comply with all required follow-up visits at investigational site\n\nExclusion Criteria:\n\n1. Prior aortic valve replacement or repair\n2. Aortic valve stenosis \\> moderate as assessed by core lab\n3. Severe mitral valve or tricuspid valve regurgitation as assessed by core lab\n4. Severe mitral valve or tricuspid valve stenosis as assessed by core lab\n5. Active infection requiring current antibiotic therapy, including infective endocarditis\n6. Cardiac imaging evidence of cardiac mass, thrombus or vegetation\n7. Inability to tolerate or a condition precluding treatment with antithrombotic (antiplatelet, anticoagulant) therapy\n8. Renal insufficiency (eGFR \\\u003C25 mL\u002Fmin\u002F1.73m2) or end stage renal disease requiring chronic dialysis\n9. Cirrhosis (Child-Pugh Class B or C)\n10. Leukopenia (WBC \\\u003C3000 cells\u002FmcL), thrombocytopenia (platelet count \\\u003C50,000 cells\u002FmcL), anemia (hemoglobin \\\u003C9 g\u002FdL), history of bleeding diathesis, coagulopathy, or hypercoagulable state (unless therapeutically stable)\n11. Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, Nitinol (Nickel, Titanium) or sensitivity to contrast media which cannot be adequately premedicated\n12. Clinically significant untreated coronary artery disease requiring revascularization or anticipated coronary revascularization procedure within 12 months post-index procedure\n13. Acute myocardial infarction within 30 days prior to index procedure\n14. PCI within 30 days prior to index procedure\n15. Carotid intervention within 6 weeks prior to index procedure or carotid artery disease requiring intervention\n16. Previous, or planned, other surgical or interventional procedures within 30 days before, during, or within 30 days after the index procedure\n17. Uncontrolled atrial fibrillation\n18. Severe right ventricular (RV) dysfunction or chronic inotrope support (\\>30 days)\n19. Severe pulmonary hypertension (systolic pulmonary artery pressure \\>80 mmHg measured by right heart catheterization)\n20. Severe chronic obstructive pulmonary disease (COPD) requiring chronic oral steroids or requiring continuous home oxygen\n21. Stroke (cerebrovascular accident, CVA), transient ischemic attack (TIA) or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to index procedure\n22. Estimated life expectancy of less than 12 months\n23. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements\n24. Participation in another investigational study that has not reached its primary endpoint\n25. Considered to be part of a vulnerable population\n\nAnatomic Exclusions:\n\n1. Ascending aortic diameter ≥5.5 cm as assessed by core lab\n2. Aortic annulus perimeter \\\u003C57 mm or \\>104 mm as assessed by core lab\n3. Inappropriate anatomy for femoral introduction and delivery of the study system\n4. Congenital aortic valve disease including unicuspid, bicuspid, or quadricuspid aortic valve anatomy as assessed by core lab\n5. Congenital univentricle or other condition that, in the opinion of the investigator and\u002For consulting physician, may constitute an unwarranted surgical risk\n6. Excessive aortic valve prolapse or leaflet deterioration that would preclude proper seating of the implant in the aortic annulus\n7. Abdominal\u002Fthoracic aortic aneurysm ≥5.0 cm as assessed by core lab\n8. Aorto-iliac disease requiring intervention to facilitate delivery of access sheath\n9. Excessive tortuosity of delivery system pathway, defined as severe tortuosity of multiple vessels including iliofemoral, thoracoabdominal aorta, aortic arch, and\u002For LV-aortic root angle \\>80°",{"count":82,"type":21},50,[24],"The objective of this study is to assess the safety and effectiveness of the J-Valve Transfemoral Transcatheter Heart Valve System in patients on left ventricular assist device (LVAD) support with significant native aortic valve regurgitation (AR).",[27,28,86],"Aortic Insufficiency",[30,31,32,33,34,88,89],"Left Ventricular Assist Device","LVAD","NOT_YET_RECRUITING","2026-03-03",{"date":93,"type":39},"2026-03-05",{"date":95,"type":21},"2026-04",{"date":97,"type":21},"2029-11",{"name":45,"class":46},{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":112,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":126},"100472974","early-aortic-valve-surgery-versus-watchful-waiting-strategy-in-severe-asymptomatic-aortic-regurgitation-100472974","NCT05438862","Early Aortic vaLve surgEry Versus wAtchful waitiNg Strategy in Severe Asymptomatic aOrtic reguRgitation","Early Aortic Valve Surgery Versus Watchful Waiting Strategy in Severe Asymptomatic Aortic Regurgitation","ELEANOR","Inclusion Criteria:\n\n* Chronic asymptomatic aortic regurgitation grade 3 (moderate to severe) and grade 4 (severe)\n* No indication for the surgical treatment at the time of enrolment\n* LV ejection fraction \\>50%\n* Absence of more than mild-to-moderate concomitant valve disease or complex congenital heart disease\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Clearance Creatinine \\\u003C30 mL\u002Fmin\n* Contraindication for magnetic resonance (implanted active device, ferromagnetic implant incompatible with magnetic resonance scanner, cerebral aneurysm clip, metallic fragment in the eye or near sensitive tissue)\n* Pregnancy\n* Permanent atrial fibrillation.",{"count":108,"type":21},217,[24],"The optimal timing of surgical intervention in asymptomatic patients with severe aortic regurgitation remains controversial. As per cardiac magnetic resonance assessment, early surgical treatment will be compared with conventional guideline-based strategy in asymptomatic patients with severe aortic regurgitation.",[27],[113,114,115,116],"aortic regurgitation","cardiac magnetic resonance","echocardiography","early surgical intervention","2026-02-13",{"date":119,"type":39},"2026-02-17",{"date":121,"type":39},"2022-09-01",{"date":123,"type":21},"2027-12-31",{"name":125,"class":72},"Na Homolce Hospital",8,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":138,"conditions":139,"keywords":152,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":164},"100613478","cohort-observing-mechanisms-progression-and-sequelae-of-valvular-heart-disease-100613478","NCT07267117","Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease","Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease (VALVE-COMPASS)","VALVE-COMPASS","Inclusion Criteria:\n\n* At least 18 years old;\n* Be willing and able to provide informed consent to participate in the study;\n* Patients with heart valve disease diagnosed by echocardiography who meet one of the following criteria:\n\n  1. Grade II or higher Aortic valve regurgitation: regurgitant jet width \\>3 mm, jet width \u002F LVOT diameter ≥25%, jet cross-sectional area\u002FLVOT cross-sectional area ≥5%, effective regurgitant orifice area (EROA) ≥0.1 cm², regurgitant volume per beat (R Vol)≥30 ml, or regurgitant fraction (RF) ≥30%.\n  2. Moderate or higher aortic valve stenosis: peak velocity ≥3.0 m\u002Fs, Mean gradient ≥20 mm Hg, aortic valve area ≤1.5 cm², Indexed aortic valve area ≤0.85 cm²\u002Fm², or velocity ratio ≤0.50.\n  3. Grade II or higher mitral valve regurgitation: regurgitant jet width ≥3 mm, regurgitant volume per beat ≥30 ml, regurgitant jet area\u002Fleft atrial area \\>30%, or effective regurgitant orifice area (EROA) ≥0.2 cm².\n  4. Moderate or higher valve stenosis: valve area (specific finding) ≤1.5 cm², or mean gradient (supportive finding) ≥10.0 mmHg.\n  5. Grade II or higher tricuspid valve regurgitation: regurgitant jet width ≥3 mm, proximal isovelocity surface area ≥6 mm, effective regurgitant orifice area (EROA) ≥0.2 cm², or regurgitant volume per beat ≥30 ml.\n  6. Significant tricuspid valve stenosis: mean pressure gradient ≥5.0 mmHg, inflow time-velocity integral \\>60 cm, T1\u002F2 ≥190 ms, or valve area ≤1.0 cm².\n  7. Grade II or higher pulmonary valve regurgitation: regurgitant jet width \\>3 mm, regurgitant volume per beat ≥30 ml, regurgitant fraction ≥30%, or effective regurgitant orifice area (EROA) ≥0.1 cm².\n  8. Moderate or higher Pulmonary valve stenosis: pulmonary valve transvalvular pressure gradient ≥40 mmHg, right ventricular systolic pressure ≥60 mmHg, or pulmonary valve opening \\\u003C1.5 cm².\n\nExclusion Criteria:\n\n* Patients who are unwilling to accept registration and follow-up;\n* Patients who cannot cooperate with information collection and follow-up due to mental illness or other conditions;\n* Patients whose life expectancy is less than 12 months due to non-cardiac diseases (such as cancer, liver disease, kidney disease, or end-stage lung disease).",{"count":136,"type":21},10000,"OBSERVATIONAL","The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging (MRI) data. Additionally, the study aims to analyze the potential impact of device-based interventions, pharmacological therapy, and lifestyle modifications on disease progression.",[140,141,142,143,144,61,145,146,27,147,148,149,150,151],"Heart Valve Disease","Mitral Valve (MV) Regurgitation","Mitral Valve Disease","Mitral Valve Stenosis","Aortic Valve Disease","Tricuspid Valve Disease","Tricuspid Valve Regurgitation","Pulmonary Valve Disease","Transcatheter Valve Replacement","Transcatheter Aortic Valve Replacement (TAVR)","Transcatheter Pulmonary Valve Replacement (TPVR)","Transcatheter Edge-to-edge Repair",[153,154],"Heart Valve Disease Progression","Heart Valve disease sequelae","2025-11-25",{"date":157,"type":39},"2025-12-05",{"date":159,"type":39},"2025-06-01",{"date":161,"type":21},"2030-05-31",{"name":163,"class":72},"Second Affiliated Hospital, School of Medicine, Zhejiang University",15,{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":22,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":4},"100602892","evaluation-of-safety-and-effectiveness-of-the-emblok-eps-compared-with-no-cerebral-embolic-protection-during-tavr-100602892","NCT07129421","Evaluation of Safety and Effectiveness of the EMBLOK EPS Compared With No Cerebral Embolic Protection During TAVR","A Prospective, Randomized, Multicenter Evaluation of the Safety and Effectiveness of the EMBLOK™ Embolic Protection System Compared With No Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement","EMBLOK II","Clinical Eligibility Criteria:\n\nClinical Inclusion Criteria:\n\nSubjects must meet all the following criteria to be eligible for participation in the study:\n\n1. Subject is ≥ 18 years of age.\n2. Subject meets FDA approved indications for TAVR using an iliofemoral approach with a commercially approved transcatheter heart valve.\n3. Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to the index study procedure.\n4. Subject agrees to comply with all protocol-specified procedures and assessments.\n5. Subject or subject's legal representative signs an IRB\u002FEC approved informed consent form prior to study participation.\n\nClinical Exclusion Criteria:\n\nSubjects will be excluded if any of the following criteria apply:\n\n1. Subjects with hepatic failure (Child-Pugh class C).\n2. Subjects with hypercoagulable states that cannot be corrected by additional periprocedural heparin.\n3. Subjects who have a planned treatment with any other investigational device or procedure during the study period.\n4. Subjects planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 10 days prior to the TAVR procedure. NOTE: Diagnostic cardiac catheterization is permitted within 10 days prior to the TAVR procedure.\n5. Subject has experienced an acute myocardial infarction (World Health Organization \\[WHO\\] criteria) within 30 days of the planned index procedure.\n6. Subject requires an urgent or emergent TAVR procedure.\n7. Subjects with renal failure (estimated Glomerular Filtration Rate \\[eGFR\\] \\\u003C 30 mL\u002Fmin by the Modification of Diet in Renal Disease \\[MDRD\\] formula, or on dialysis).\n8. Subject has documented history of stroke or transient ischemic attack within prior 6 months, or any prior stroke with a permanent major disability or deficit (baseline mRS ≥3).\n9. Subject has an ejection fraction of 30% or less.\n10. Subject has a sensitivity to contrast media that cannot be adequately pre-treated.\n11. Subject has known allergy or hypersensitivity to any embolic protection device materials (e.g., nickel-titanium) or allergy to intravascular contrast agents that cannot be pre-medicated.\n12. Subject has active endocarditis or an ongoing systemic infection defined as fever with temperature \\> 38°C and\u002F or white blood cell \\> 15,000 IU.\n13. Subjects undergoing therapeutic thrombolysis.\n14. Subject has history of bleeding diathesis or a coagulopathy or contraindications to anticoagulation and antiplatelet therapy.\n15. Subject is known or suspected to be pregnant, or is lactating.\n16. Subject has contraindications to cerebral MRI (e.g., body habitus that precludes imaging, claustrophobia, implanted non-MRI compatible permanent pacemaker or defibrillator, metallic clips or fragments).\n17. In the investigator's opinion, the subject has other factors that may cause the subject to be non-compliant with the protocol or confound the data interpretation, such as participating in another drug or device clinical study, or other medical illness.\n\nGeneral Anatomic Exclusion Criteria\n\nSubjects meeting any of the following criteria will not be eligible for participation in the study:\n\n1. Non-iliofemoral approach is required for the TAVR system (e.g., trans-axillary, trans-subclavian, trans-brachiocephalic, trans-carotid, trans-apical or trans-aortic access for TAVR is required).\n2. Subject peripheral anatomy is not compatible with contralateral iliofemoral access with an 11 French catheter (e.g., due to excessive tortuosity, stenosis, ectasia, dissection, or aneurysm).\n3. Ascending aorta length (from the brachiocephalic artery takeoff to the most distal edge of the TAVR prosthetic device) less than 3.5 cm.\n4. Diameter of the aorta at the intended site of Emblok filter deployment proximal to the brachiocephalic artery ostium is less than 25 mm or greater than 40 mm.\n5. Subjects with severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery sheath vascular access.\n6. Subjects in whom the aortic arch is heavily calcified, severely atheromatous, or severely tortuous.",{"count":174,"type":21},560,[24],"The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with TAVR without embolic protection (unprotected TAVR). The targeted study population consists of patients meeting FDA-approved indications for TAVR with commercially available transcatheter heart valve systems.\n\nThis prospective, multicenter, single-blind, randomized controlled trial will enroll up to a total of 560 subjects undergoing TAVR at up to 40 investigational sites in the United States. All subjects will undergo clinical follow-up (including detailed neurological assessments) in-hospital and at 30 days, and diffusion-weighted magnetic resonance imaging (DW-MRI) follow-up at 24 to 36 hours post-procedure.",[178,179,27,180],"AORTIC VALVE DISEASES","Aortic Valve Stenosis and\u002For Insufficiency","Aortic Valve Replacement","2025-08-11",{"date":183,"type":39},"2025-08-19",{"date":185,"type":21},"2025-10-21",{"date":187,"type":21},"2027-03-15",{"name":189,"class":46},"Emblok, Inc.",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":17,"minAge":197,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":199,"briefSummary":200,"conditions":201,"keywords":202,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":4},"100602458","clinical-investigation-for-the-poliavalve-aortic-heart-valve--india-100602458","NCT07123766","Clinical Investigation for the PoliaValve Aortic Heart Valve- India","A Prospective, Multicenter, Single-Arm Study With Objective Performance Criteria Evaluating the Efficacy and Safety of PoliaValve® Artificial Heart Valve","Inclusion Criteria:\n\n* Is 45 years or older\n* Provide written informed consent prior to trial procedures after standard of care studies and tests indicate that the patient needs aortic valve replacement\n* Agrees to attend all follow-up assessments for up to 1 year and is willing to comply with specified follow-up evaluations for the clinical trial\n* Diagnosed with severe symptomatic aortic valve stenosis and\u002For regurgitation\n\nExclusion Criteria:\n\n* Requires multiple valve replacement \u002F repair\n* Requires emergency surgery\n* Has had prior valve surgery\n* Requires a surgical procedure outside of the cardiac area\n* Requires a cardiac procedure other than a CABG or root enlargement or aortic root replacement\n* Requires or are planning another unrelated surgery within 12 months of undergoing implantation of the study device\n* Has active endocarditis\u002Fmyocarditis or within 3 months to the scheduled surgery\n* Has renal insufficiency as determined by creatinine (S-Cr) level as ≥ 1.5 mg\u002Fdl or end-stage renal disease requiring chronic dialysis at screening visit\n* Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months (90 days) prior to planned valve surgery\n* Has acute myocardial infarction (AMI) within 30 days prior to planned valve surgery\n* Has life expectancy to less than 12 months\n* Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM), except patients who have isolated subaortic muscular hypertrophy diagnosed at the time of surgery\n* Diagnosed with abnormal calcium metabolism and\u002For hyperparathyroidism\n* Echocardiographic left ventricular ejection fraction \\\u003C25%\n* Echocardiographic evidence of an intra-cardiac thrombus or vegetation\n* Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery\n* Documented leukopenia (WBC \\\u003C 4.0 x 103\u002FµL), acute anemia (Hgb \\\u003C 10.0 gm\u002Fdl or 6 mmol\u002FL), thrombocytopenia (platelet count \\\u003C 100 x103\u002FµL) or history of bleeding diathesis or coagulopathy\n* Has prior organ transplant or is currently an organ transplant candidate\n* Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial\n* Pregnant, lactating or planning to become pregnant during the duration of participation in trial\n* Currently incarcerated or unable to give voluntary informed consent\n* Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant\n* Requires concomitant left ventricular assist device (LVAD) placement, Impella placement, and\u002For intra-aortic balloon pump\n* Currently has uncontrolled infection\n* Currently diagnosed as uncontrolled diabetes mellitus (Random BLS \\> 300 mg\u002Fdl)","45 Years",{"count":82,"type":21},[24],"The purpose of this study is to conduct a clinical investigation of the HeartHill PoliaValve Aortic Valve to collect evidence on the device's safety and performance.",[178,61,27],[203,27,144,204],"Heart Valve Diseases","Polymeric Aortic Valve","2025-08-08",{"date":207,"type":39},"2025-08-14",{"date":209,"type":21},"2025-11-15",{"date":211,"type":21},"2027-12-30",{"name":213,"class":46},"Suzhou Hearthill Medical Technology Co.,LTD",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":224,"conditions":225,"keywords":231,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":245},"100577973","left-ventricular-reverse-remodeling-evaluation-after-surgical-correction-of-aortic-regurgitation-100577973","NCT06805253","Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation","Left Ventricular Reverse Remodeling Outcomes Evaluation in Patients With Aortic Regurgitation After Surgical Treatment","ORMIX","Inclusion Criteria:\n\n* Age over 18 years\n* Planned primary elective surgery for chronic aortic regurgitation\n* Presence of functional mitral regurgitation\n* End-diastolic volume of the left ventricle \\>= 250 ml\n\nExclusion Criteria:\n\n* Infectious endocarditis\n* History of myocardial infarction\n* Indications on simultaneous myocardial revascularisation\n* Acute aortic regurgitation of any etiology\n* Previously diagnosed dilatation of the left ventricle, not associated with the development of aortic regurgitation\n* Long-term persistent or permanent form of atrial fibrillation\n* Pregnancy in the first 12 months after surgery\n* Simultaneous participation in other studies\n* Presence of implanted pacemakers\n* Refusal to sign informed consent\n* Acute coronary event diagnosed within 12 months after aortic valve surgery\n* Indications for resynchronization therapy or permanent right ventricular pacing in the first 12 months after aortic valve surgery\n* Re-do cardiac surgery for any reason within 12 months after aortic valve surgery",{"count":223,"type":21},120,"Investigators assume that surgical correction approach to functional mitral regurgitation during intervention for chronic aortic regurgitation in patients with severe enlargement of the left heart chambers influences reverse remodeling of the left ventricle (LV) in the postoperative period. It is suggested that functional mitral regurgitation (MR) provides supra-physiological left ventricle volume overload and this fact plays positive role in early-stage post-operative left ventricle volume and function recovery. LV volume, systolic and diastolic function will be monitored with echocardiography (EchoCG) along with life quality in patients with different grades of functional mitral regurgitation secondary to severe chronic aortic insufficiency after surgical treatment of aortic regurgitation.",[27,226,227,228,229,230],"Mitral Valve Regurgitation","Left Ventricle Dilated","Left Atrium Dilated","Systolic Left Ventricular Heart Failure","Diastolic Heart Failure",[232,233,234,235],"reverse remodeling","left ventricle dilatation","mitral valve functional regurgitation recovery","left ventricle reverse remodeling","2025-06-05",{"date":238,"type":39},"2025-06-11",{"date":240,"type":39},"2024-05-09",{"date":242,"type":21},"2030-05",{"name":244,"class":72},"Petrovsky National Research Centre of Surgery",2,{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":22,"phases":256,"briefSummary":257,"conditions":258,"keywords":260,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":270,"locationsCount":272},"100423722","clinical-evaluation-of-the-free-margin-cusp-sizer-calibrate-100423722","NCT04797572","Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)","CALIBRATE TRIAL: a Prospective, Single Arm Investigational Clinical Trial Evaluating Safety and Performance of the Free Margin Cusp Sizer During Aortic Valve Repair Surgery","CALIBRATE","Inclusion Criteria:\n\n* Patients with Tricuspid Aortic Valve (TAV) operated electively for aortic valve regurgitation and or ascending aorta dilatation.\n\nExclusion Criteria:\n\n* Acute aortic dissection;\n* Diffuse aortic valve calcification;\n* AV endocarditis;\n* Bicuspid, unicuspid or quadricuspid aortic valves;\n* Patients under the age of 18 years;\n* Patients above the age of 80 years.","80 Years",{"count":223,"type":21},[24],"The objective of this study is to investigate safety and performance of the Free Margin Cusp sizer. The device will be used during aortic valve repair and sparing procedures as a caliper to measure the aortic valve free margin length at different stages of the procedure. The patient will be followed for one year clinically (at 1, 2, 6 and 12 months) and by echocardiography (at 6 and 12 months) to assess aortic valve function.",[27,259],"Aortic Root Aneurysm",[261,262,263],"aortic valve repair","Valve sparing surgery","Trileaflet aortic valve","2025-05-13",{"date":266,"type":39},"2025-05-16",{"date":268,"type":39},"2021-03-22",{"date":211,"type":21},{"name":271,"class":72},"Cliniques universitaires Saint-Luc- Université Catholique de Louvain",1,{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":4},"100572783","clinical-trial-evaluating-the-safety-and-efficacy-of-artificial-polymer-heart-valve-for-the-treatment-of-aortic-valve-disease-100572783","NCT06737757","Clinical Trial Evaluating the Safety and Efficacy of Artificial Polymer Heart Valve for the Treatment of Aortic Valve Disease","Prospective, Multicenter, Randomized Controlled, Non-Inferiority Clinical Trial Evaluating the Safety and Efficacy of Artificial Polymer Heart Valve for the Treatment of Aortic Valve Disease","Inclusion Criteria:\n\n1. The subjects are aged ≥18 years old;\n2. The subjects understand the nature and purpose of the study, voluntarily participate, and sign the informed consent form. They agree to comply with the trial requirements, cooperate with surgical treatment and follow-up, and consent to relevant follow-up inquiries and examinations;\n3. The subjects have been confirmed to have severe aortic valve stenosis and\u002For regurgitation (also known as insufficiency) through echocardiography;\n4. According to the 2020 ACC\u002FAHA guidelines for the management of patients with valvular heart disease, the subjects meet the indications for surgical aortic valve replacement and preoperative assessment recommends surgical aortic valve replacement.\n\nExclusion Criteria:\n\n1. Other valve diseases with surgical indications, such as severe mitral regurgitation, severe tricuspid regurgitation, moderate or greater mitral stenosis, or a history of previous aortic or other valve replacement surgery;\n2. Other severe cardiovascular conditions with surgical indications, such as Stanford A-type aortic dissection, aortic sinus aneurysm (sinus diameter \\> 5.0cm), hypertrophic obstructive cardiomyopathy, diffuse three-vessel coronary artery disease, or placement of a left ventricular assist device in end-stage heart failure;\n3. End-stage heart failure that is not reversible even with aortic valve surgery, such as severe left ventricular dysfunction (LVEF \\\u003C 25%), or severe heart failure that cannot be corrected, or severe pulmonary hypertension assessed by right heart catheterization, with planned postoperative Impella, IABP, or left ventricular assist;\n4. Preoperative decompensated heart failure, cardiogenic shock, malignant arrhythmias, etc., requiring mechanical circulatory support, mechanical ventilation, or emergency surgery;\n5. Active endocarditis within the past 3 months or the presence of cardiac vegetations;\n6. Severe acute myocardial infarction or history of cerebrovascular accidents within the past 3 months (excluding lacunar infarcts);\n7. Severe renal insufficiency (glomerular filtration rate \\\u003C 30mL\u002Fmin) or end-stage renal disease requiring long-term dialysis;\n8. Liver dysfunction or gastrointestinal malnutrition-related diseases;\n9. Active bleeding, bleeding tendencies, or patients unable to receive anticoagulant therapy;\n10. Severe respiratory or ventilatory dysfunction requiring continuous oxygen therapy;\n11. Poor compliance or cognitive impairment (such as coma, Parkinson's disease, dementia, substance abuse), inability to follow study requirements or refusal to participate in follow-up visits;\n12. Other conditions with an expected lifespan of less than 1 year, such as malignancies and immunodeficiency diseases;\n13. Other situations not suitable for artificial aortic valve replacement or participation in this trial.",{"count":281,"type":21},198,[24],"The purpose of this study is to conduct the clinical investigation of the HeartHill Medical's polymer aortic valve, namely PoliaVavle，to collect evidence on the device's safety and performance. This prospective, multicenter, randomized controlled, non inferiority clinical trial is expected to enroll 198 subjects and conduct a 1:1 random grouping. The experimental group will use polymer material surgical aortic valves（PoliaVavle, HeartHill Medical, Suzhou China) for aortic valve replacement, while the control group will use bovine pericardial biological valves for aortic valve replacement.",[61,144,27],"2024-12-23",{"date":287,"type":39},"2024-12-30",{"date":289,"type":21},"2024-12",{"date":291,"type":21},"2029-12",{"name":213,"class":46},{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":299,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":272},"100398171","a-10-minute-cardiovascular-magnetic-resonance-protocol-for-cardiac-disease-100398171","NCT04464655","A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease","Healthy Volunteers\n\nInclusion Criteria:\n\n* Age: \\> 18y, Informed consent No known current or pre-existing significant medical conditions that would affect the cardiovascular or respiratory system\n\nExclusion Criteria:\n\n* General MRI contraindications: MR- incompatible devices such as pacemakers, defibrillators, or implanted material or foreign bodies. Consumption of caffeinated drinks or foods (including cocoa and chocolate) during the 12 hours prior to the exam.Regular nicotine consumption during the last 6 months\n\nPatients\n\nInclusion Criteria:\n\n* Age: \\>18 y, Informed consent, Clinically indicated CMR exam\n\nExclusion Criteria:\n\n* General MRI contraindications: MR- incompatible devices such as pacemakers, defibrillators, or implanted material or foreign bodies Vasoactive medication (e.g. nitro) during the 12 hours prior to the exam. Consumption of caffeinated drinks or foods (including cocoa and chocolate) during the 12 hours prior to the exam.\n\nRegular nicotine consumption during the last 6 months",true,{"count":301,"type":21},2130,"This study aims to identify and assess new CMR techniques that can improve current CMR protocols.",[304,305,306,307,308,61,27,309,310,311],"Coronary Artery Disease","Myocarditis","Infiltrative Cardiomyopathy","Dilated Cardiomyopathy","Hypertrophic Cardiomyopathy","Pericardial Effusion","Congenital Heart Disease","Vascular Anomaly","2024-10-22",{"date":314,"type":39},"2024-10-24",{"date":316,"type":39},"2019-12-12",{"date":318,"type":21},"2025-01-31",{"name":320,"class":72},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":330,"conditions":331,"keywords":332,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":272},"100545389","transcatheter-aortic-valve-replacement-for-pure-severe-aortic-valve-regurgitation-100545389","NCT06381271","Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation","Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation: a Real-world, Prospective, Multicenter Study (TRUST TAVR Registry)","Inclusion Criteria:\n\n* 1\\. Patients diagnosed with severe aortic valve regurgitation undergo evaluation by the Heart team and are eligible for TAVR therapy.\n* 2\\. Patients who understand the purpose of this study, agree to participate in the trial and sign the informed consent form\n\nExclusion Criteria:\n\n* 1\\. Patients who cannot provide informed consent\n* 2\\. Patients who are treated with TAVR for aortic stenosis\n* 3\\. Patients who are participating in other clinical trials",{"count":329,"type":21},500,"The purpose of this multicenter, prospective and observational registry is to evaluate the safety and efficacy of TAVR for treatment of pure severe aortic valve regurgitation. Baseline characteristics, procedural and clinical data will be collected",[27],[27,33,333],"Real-Word","2024-04-18",{"date":336,"type":39},"2024-04-24",{"date":338,"type":39},"2018-10-30",{"date":340,"type":21},"2034-10",{"name":342,"class":72},"Xijing Hospital",{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":351,"targetDuration":353,"studyType":137,"phases":4,"briefSummary":354,"conditions":355,"keywords":361,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":372},"100480463","tavis-registry---trilogy-heart-valve-system-for-management-of-patients-with-aortic-valve-disease-100480463","NCT05536310","TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease","Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease: Patient Registry and Post-Market Clinical Follow-up Study","TAVIS","Inclusion Criteria:\n\n1. Patients who have signed ICF and are indicated by their doctors to be treated with Trilogy Heart Valve System in line with the medical standard of care\n2. Patients with symptomatic severe aortic regurgitation (AR) or symptomatic, severe aortic stenosis (AS), who are at high risk for SAVR as documented by the heart team and Heart Team agrees that patient can undergo SAVR for \"bail out\"\u002Fto address unfavorable circumstances if necessary\n3. Patients 18 years of age or older\n4. Patient is willing to participate in the study, provides signed Informed Consent\u002FData Authorization Form and authorizes the sharing of data in the study\n5. The subject and treating physician agree the subject will return for all required post-procedure follow-up visits\n\nExclusion Criteria:\n\n1. Patients who have known hypersensitivity or contraindication to Nitinol (titanium and\u002For nickel), an anti-coagulation\u002Fanti-platelet regimen or contrast medium that cannot be managed with premedication\n2. Patients who have active bacterial endocarditis or other active infections\n3. Pediatric (\\\u003C18 years) and\u002For pregnant\u002Fnursing patients\n4. Congenital\u002Ffunctional unicuspid, bicuspid or quadricuspid native aortic valve morphology\n5. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant\n6. Echocardiographic evidence of current left heart thrombus\n7. Hypertrophic cardiomyopathy with or without obstruction.\n8. Access vessel characteristics that would preclude safe placement of the JenaValve 20Fr introducer sheath, such as severe obstructive calcification, severe tortuosity, or vessel diameter \\\u003C7mm.",{"count":352,"type":21},600,"5 Years","To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).",[61,27,356,357,144,203,358,359,360],"Aortic Valve Stenosis With Insufficiency","Constriction, Pathologic","Cardiovascular Diseases in Old Age","Ventricular Outflow Obstruction","Aortic Stenosis, Severe",[362,144,363,27],"Trilogy","Transcatheter aortic valve replacement (TAVR)","2023-01-10",{"date":67,"type":39},{"date":367,"type":21},"2023-03",{"date":369,"type":21},"2027-10",{"name":371,"class":46},"JenaValve Technology, Inc.",3]