[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-valve-disease-mixed\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-valve-disease-mixed":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,73],{"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":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"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":56,"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).",[27,28,60],"Aortic Insufficiency",[30,31,32,33,34,62,63],"Left Ventricular Assist Device","LVAD","NOT_YET_RECRUITING","2026-03-03",{"date":67,"type":39},"2026-03-05",{"date":69,"type":21},"2026-04",{"date":71,"type":21},"2029-11",{"name":45,"class":46},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":82,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100535839","safety-and-efficacy-of-post-marketing-transcatheter-aortic-valves-in-real-world-chinese-patients-100535839","NCT06257043","Safety and Efficacy of Post-marketing Transcatheter Aortic Valves in \"Real World\" Chinese Patients","RECORD TAVR REGISTRY: Prospective, Multi-Center Registry of \"Real World\" Chinese Patients Undergoing Transcatheter Aortic Valve Replacement","Inclusion Criteria:\n\n1. Patients with aortic valve disease are evaluated by the cardiac team and indicate TAVR therapy\n2. Patients who understand the purpose of this study, voluntarily participate in the trial and sign the informed consent form\n\nExclusion Criteria:\n\n1. Patients with aortic valve disease who have been evaluated by a cardiac team as unsuitable for TAVR\n2. Patients who cannot tolerate the materials or medications associated with this study\n3. Women who are pregnant or breastfeeding\n4. Patients who participated in a clinical trial of another drug or medical device before enrollment",{"count":81,"type":21},3000,"10 Years","OBSERVATIONAL","The purpose of this prospective multi-center, observational registry in China is to collect clinical baseline, procedural, and follow-up data of all patients treated with TAVR in China and to evaluate short-, mid-, and long-term clinical outcome data of all post-marketing transcatheter valves. Each center will collect baseline and procedural data as well as clinical outcomes for up to 10 years.",[28],[87,88,33],"Aortic Valve Disease","Real world","2024-04-18",{"date":91,"type":39},"2024-04-19",{"date":93,"type":39},"2023-10-30",{"date":95,"type":21},"2034-01-01",{"name":97,"class":98},"Xijing Hospital","OTHER",1]