[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-insufficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-insufficiency":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,42,67,100,128,156,177],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100562873","artist-aortic-regurgitation-trial-investigating-surgery-versus-trilogy-100562873",false,"NCT06608823","ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™","A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Transcatheter Heart Valve System Versus Surgical Valve Replacement in Patients With Aortic Regurgitation","ARTIST","Inclusion Criteria:\n\n1. Clinical indication for AVR for native valve predominant AR defined as:\n\n   1. Class I or II indication for AVR according to ACC\u002FAHA or ESC\u002FEACTS guidelines with moderate to severe or severe AR (Grade ≥3+) on transthoracic echocardiography, transesophageal echocardiography or cardiac MRI as assessed by the core laboratory OR\n   2. AR severity that remains indeterminate despite core laboratory review of all imaging including at least one advanced imaging modality (TEE or cardiac MRI) AND evidence of left ventricular damage\\* from AR with unanimous agreement from the local heart team, an independent clinical evaluation committee and the CRB that the symptomatic subject (NYHA II or greater) will benefit from SAVR for AR\n2. The subject is a candidate for TAVR using the Trilogy THV system and SAVR using a commercially approved bioprosthetic heart valve\n3. Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits\n4. Subject meets the legal minimum age to provide informed consent based on local regulatory requirements\n\nExclusion Criteria:\n\n1. Confirmed moderate (2+) or less AR severity by core laboratory evaluation\n2. Estimated life expectancy of less than 24 months due to associated non- cardiac comorbid conditions\n3. Subject is high-risk for SAVR as determined by the local heart team\n4. Subject refuses SAVR as a treatment option\n5. Subject refuses a blood transfusion\n6. Subject is selected for aortic valve repair or aortic surgery\n7. Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement\u002Fintervention\n8. Subject unable to undergo pre-procedure CT scan analysis for annular sizing\n9. Mitral or tricuspid disease, considered clinically significant, such that if randomized to surgery, repair or replacement would be expected.\n10. Subject has a known hypersensitivity or contraindication to all anticoagulation\u002Fantiplatelet medications (or inability to be anticoagulated for the index procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated\n11. Hostile chest or conditions or complications from a prior surgery that would preclude safe reoperation (i.e., mediastinitis, radiation damage, chest wall abnormalities, adhesion of aorta or internal mammary artery (IMA) to the sternum)\n12. Need for emergency surgery or TAVR for any reason\n13. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or need for mechanical circulatory support\n14. Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks\n15. Cardiac resynchronization therapy (CRT) device implantation within 30 days of randomization\n16. LVEF \\<25% according to core laboratory measurement of resting echocardiogram at time of screening\n17. Moderate to severe or worse right ventricular dysfunction on resting echocardiogram according to core laboratory\n18. Severe chronic liver disease (Child-Pugh C) or any active liver disease\n19. Chronic Kidney Disease Stage 4 or 5 (\\<30 cc\u002Fmin\u002F1.73 m2 or dialysis)\n20. Severe Pulmonary Hypertension (pulmonary arterial systolic pressure\n\n    * amp;amp;gt;2\u002F3 systemic systolic pressure)\n21. Severe Chronic Obstructive Pulmonary Disease (COPD) with FEV1\n\n    * amp;amp;lt;50% predicted or need for chronic supplementary oxygen\n22. Blood dyscrasia as defined: leukopenia (WBC \\<3,000 Cells\u002FμL), thrombocytopenia (platelet count \\<50,000 Cells\u002FμL), or anemia (hemoglobin \\<9.0 g\u002FdL) that is uncorrected prior to randomization\n23. History of bleeding diathesis or coagulopathy that is not adequately treated\n24. Active gastrointestinal bleeding precluding anticoagulation or antiplatelet therapy\n25. Any condition considered a contraindication to mechanical circulatory support\n26. Uncontrolled atrial fibrillation (i.e., resting heart rate \\>120 bpm)\n27. Evidence of an acute myocardial infarction ≤30 days before the index AVR\n28. Any percutaneous coronary or peripheral interventional procedure performed ≤30 days prior to AVR (Subjects with placement of coronary or peripheral stent(s) should be assessed for the ability to safely proceed with SAVR within the protocol timeframe)\n29. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization\n30. Prior stroke with residual modified Rankin Score ≥2\n31. Stroke or transient ischemic attack (TIA) within 6 months of randomization\n32. Body mass index (BMI) \\<20 or \\>50 kg\u002Fm2\n33. Currently participating in a cardiovascular investigational drug or device trial and has not yet completed follow-up for the primary endpoint (excluding registries)\n34. Severe cognitive decline (resulting in either inability to provide informed consent for the trial\u002Fprocedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)\n35. Other medical, social, or psychological conditions that in the opinion of the investigator preclude the subject from appropriate consent or adherence to the protocol required follow-up exams\n36. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements\n37. Anatomical exclusion criteria (ANY of the following):\n\n    1. Congenital bicuspid, unicuspid or quadricuspid aortic valve verified by echocardiography or CCT core laboratory\n    2. Native aortic annulus perimeter \\<66 mm or \\>90 mm per the core laboratory reading of baseline cardiac CT imaging\n    3. Iliofemoral arteries with vessel characteristics unsuitable for sheath passage (e.g., calcification, tortuosity) as determined by the case review board (CRB)\n    4. Significant abdominal or thoracic aortic disease (such as porcelain aorta, aneurysm, severe calcification, aortic coarctation) that would preclude safe passage of the delivery system or cannulation and aortotomy for SAVR\n    5. According to the CRB, a combination of aortic root angulation (angle between the plane of the aortic valve annulus and horizontal plane\u002Fvertebrae), sinus size, and straight length of the aorta that will not allow safe device delivery and THV deployment\n    6. Sinus of Valsalva anatomy that would prevent adequate coronary perfusion after valve implantation\n38. According to core laboratory evaluation, severe aortic stenosis\n39. Uncorrected hypertrophic obstructive cardiomyopathy\n40. Echocardiographic or Multi-slice CT (MSCT) evidence of untreated intracardiac mass or vegetation\n41. Left ventricular thrombus\n42. Left atrial thrombus without continuous appropriate anticoagulation within 90 days of the study procedure\n43. Complex coronary artery disease:\n\n    1. Unprotected left main coronary artery disease ≥50%\n    2. Syntax score \\>32 (in the absence of prior revascularization)\n    3. Heart Team determines that optimal revascularization cannot be adequately performed with EITHER CABG at the time of SAVR OR PCI at least 30 days prior to THV implant.","ALL",{"count":19,"type":20},1016,"ESTIMATED","INTERVENTIONAL",[23],"NA","To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System compared with surgical aortic valve replacement (SAVR) for treatment of subjects with clinically significant native aortic regurgitation (AR)",[26,27,28],"Aortic Regurgitation","Aortic Valve Insufficiency","Aortic Insufficiency","RECRUITING","2026-06-22",{"date":32,"type":33},"2026-06-25","ACTUAL",{"date":35,"type":33},"2025-06-18",{"date":37,"type":20},"2036-02",{"name":39,"class":40},"JenaValve Technology, Inc.","INDUSTRY",28,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100561787","the-jenavalve-align-ar-lvad-registry-100561787","NCT06594705","The JenaValve ALIGN-AR LVAD Registry","Transcatheter Aortic Valve Replacement Using the JenaValve TrilogyTM Heart Valve System for Clinically Significant Aortic Regurgitation in Patients With Left Ventricular Assist Devices (LVAD)","JENA-VAD","Inclusion Criteria:\n\n1. Subjects \\>=18 years of age with continuous flow LVAD (cfLVAD) with clinically significant AR1 leading to cfLVAD dysfunction using cfLVAD ASE guidelines that utilize contemporary management strategies for measurement of AR in patients with cfLVAD2,3:\n\n   • AR is graded from 0 to 6 (0 = none; 1 = trace; 2 = mild; 3 = mild-to-moderate; 4 = moderate; 5 = moderate-to-severe; 6 = severe). Considering that AR during continuous flow LVAD (cfLVAD) support is generally both systolic and diastolic, AR is deemed significant if graded ≥ 3.1\n2. Patient with NYHA functional class III\u002FIV\n3. Patient with high risk for SAVR as documented by Heart Team.\n4. Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy™ Heart Valve System\n5. Patient or the patient's legal representative has provided written informed consent\n6. Patient or the patient's legal representative agrees to comply with all required post-procedure follow-up visits\n\nExclusion Criteria:\n\n1. Congenital uni- or bicuspid (Sievers 0) aortic valve morphology\n2. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant\n3. Mitral regurgitation \\> moderate\n4. Clinically significant coronary artery disease (CAD) requiring revascularization within 30 days prior to index procedure, or planned CAD revascularization procedure within 12 months after index procedure\n5. Echocardiographic or CT evidence of left ventricular or aortic valve thrombus\n6. Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks\n7. Hypertrophic cardiomyopathy with or without obstruction\n8. Severe pulmonary hypertension (systolic PA pressure \\>80 mmHg)\n9. Decompensated right heart failure as assessed clinically and, if available, by baseline right heart catheterization hemodynamics (e.g., right atrial pressure \\> pulmonary capillary wedge pressure and cardiac index \\\u003C 2.5 L\u002Fmin\u002Fm2\n10. Severe RV dysfunction as assessed clinically and by echocardiography\n11. Aortic annular diameter of \\\u003C21.0 mm or \\> 28.6 mm (assessed by Multi-detector CT measurement)\n12. Aortic annulus angulation \\> 70° (assessed by Multi-detector CT measurement)\n13. Straight length of ascending aorta of \\\u003C 55 mm\n14. Significant disease of ascending aorta, including ascending aortic aneurysm (defined as maximal luminal diameter of 50 mm or greater) or atheroma (including if thick \\[\\>5 mm\\], protruding or ulcerated)\n15. Myocardial infarction \\\u003C 30 days prior to index procedure\n16. Cerebrovascular event (TIA, stroke) \\\u003C 180 days prior to index procedure\n17. Blood dyscrasias as defined: leukopenia (WBC \\\u003C 3000\u002Fmm³), or thrombocytopenia (platelets \\\u003C 90,000\u002Fμl) or anemia (Men: Hgb \\\u003C 8.1 g\u002Fdl; Women: Hgb \\\u003C 7.4 g\u002Fdl)\n18. Active peptic ulcer or upper gastrointestinal bleeding \\\u003C 90 days prior to index procedure\n19. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be premedicated\n20. Subject unable to undergo pre-procedure transesophageal echocardiography or Multi-Detector CT (MDCT) scan for aortic annular sizing\n21. Patient is enrolled in another investigational medical device or drug study which has not completed the required primary endpoint follow-up. (Note: Patients involved in a long-term surveillance phase of another study are eligible for enrollment in this registry)","18 Years",{"count":52,"type":20},50,[23],"To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) who are indicated for TAVR",[26,27,28,56,57],"Aortic Valve Disease","Left Ventricular Dysfunction","2026-03-30",{"date":60,"type":33},"2026-04-01",{"date":62,"type":33},"2024-12-09",{"date":64,"type":20},"2027-08",{"name":39,"class":40},15,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100589345","prospective-long-term-evaluation-of-the-sapien-3-ultra-resilia-valve-100589345","NCT06953206","Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve","SAPIEN Ultra RESILIA Durability EU Registry - The RESOUND-EU Registry","RESOUND-EU","Inclusion criteria:\n\n* Adult patients (≥18 years)\n* Patients with severe aortic stenosis undergoing transfemoral TAVI on their native valve with S3UR valve\n* Patient is willing to attend the follow-up visits up to 10 years at the center\n\nExclusion criteria:\n\n* Lack of written informed consent\n* Emergency procedure\n* Pregnancy at time of TAVI\n\nCritieria for long-term observation (1y-10y):\n\n* Technical success at exit from procedure room (VARC-3):\n\n  * Freedom from mortality\n  * Successful access, delivery of the device, and retrieval of the delivery system\n  * Correct positioning of a single prosthetic heart valve into the proper anatomical location\n  * Freedom from surgery or intervention related to the device (excluding permanent pacemaker or PTA and stenting without major bleeding) or to a major vascular or access related, or cardiac structural complication\n* Absence of the following severe procedural and in-hospital complications (VARC-3 definitions):\n\n  * All stroke\n  * Bleeding type 3-4\n  * Myocardial infarction\n  * Need for a second valve\n  * Valve embolization\n  * Coronary obstruction\n  * Annular rupture",{"count":76,"type":20},500,"OBSERVATIONAL","Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.",[80,81,28,82],"Transcatheter Aortic Valve Replacement (TAVR)","Aortic-Stenosis","Degenerative Valve Disease",[84,85,86,87,88],"TAVR","SAPIEN 3 Ultra RESILIA Valve","S3UR","TAVI","Aortic Stenosis","NOT_YET_RECRUITING","2026-03-25",{"date":58,"type":33},{"date":93,"type":20},"2026-03-01",{"date":95,"type":20},"2037-09-30",{"name":97,"class":98},"Institut für Pharmakologie und Präventive Medizin","NETWORK",1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":127},"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":110,"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],[26,84,115,116],"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":126},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",12,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":137,"conditions":138,"keywords":141,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"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":52,"type":20},[23],"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).",[139,140,28],"Aortic Valve Regurgitation","Aortic Valve Disease Mixed",[142,143,144,84,145,146,147],"J-Valve Transfemoral System","Transcatheter Therapy","Transcatheter Aortic Valve Replacement","Transfemoral","Left Ventricular Assist Device","LVAD","2026-03-03",{"date":121,"type":33},{"date":151,"type":20},"2026-04",{"date":153,"type":20},"2029-11",{"name":155,"class":40},"JC Medical, Inc., an affiliate of Edwards Lifesciences LLC",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":99},"100580334","impact-of-anesthesia-positive-pressure-ventilation-and-modality-of-imaging-on-the-echocardiographic-assessment-of-the-severity-of-aortic-regurgitation-100580334","NCT06835946","Impact of Anesthesia, Positive Pressure Ventilation and Modality of Imaging on the Echocardiographic Assessment of the Severity of Aortic Regurgitation","Prospective Single-center Observational Trial Aimed at Investigating the Effect of General Anesthesia, Positive Pressure Ventilation and Change of Imaging Modality From Transthoracic Echo to Transesophageal Echo on the Grading of the Severity of Aortic Regurgitation.","Inclusion Criteria:\n\n* Known aortic regurgitation of any grade\n* Scheduled for a cardiac surgery procedure during which a trans-esophageal echo is planned.\n\nExclusion Criteria:\n\n* Non sinus rhythm\n* Mitral regurgitation more than mild.\n* Pre-operative critical state (according to the definition of the EuroSCORE II)\n* Presence of a prosthetic aortic valve\n* Contra-indication to trans-esophageal echo",{"count":164,"type":20},100,"The goal of this observational study is to assess the impact of imaging modality (trans-thoracic echo (TTE) vs trans-esophageal echo (TEE)), anesthesia and positive pressure ventilation on the grading of aortic insufficiency.\n\nPatients scheduled for cardiac surgery and in whom a TEE is going to be performed intra-operatively will be enrolled. The grading of the aortic insufficiency will be compared between a TTE performed immediately before the induction of general anesthesia end the TEE performed after induction of general anesthesia.",[167,28],"Aortic Regurgitation Disease","2025-04-07",{"date":170,"type":33},"2025-04-10",{"date":172,"type":33},"2025-03-01",{"date":174,"type":20},"2027-04-01",{"name":176,"class":126},"University of Liege",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":21,"phases":186,"briefSummary":187,"conditions":188,"keywords":196,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":99},"100545096","influence-of-lung-ultrasonography-on-the-prognosis-and-postoperative-outcomes-in-cardiac-surgical-patients-100545096","NCT06377449","Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients","Influence of Ultrasound Examination of the Lungs on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients","Inclusion Criteria:\n\n* open heart surgery with cardiopulmonary bypass (CPB) between 15 December 2023 and 15 December 2024\n* signed informed consent for participation in the study\n\nExclusion Criteria:\n\n* reoperations on the open heart with CPB\n* surgical procedures on lungs and lung cancer in the anamnesis\n* chronic obstructive pulmonary disease, stage III\n* chronic kidney disease, stages 4 and 5\n* patients with low Risk Score profile by the Society of Thoracic Surgeons",{"count":185,"type":20},186,[23],"The goal of this interventional is to assess advantages of the ultrasound examination of the lungs in the early postoperative period in cardiac surgical patients after heart surgeries requiring cardiopulmonary bypass. Evaluation of pulmonary complications and outcomes during mid-term follow-up, as well as comparison of ultrasound examination and traditional roentgenologic methods (X-ray examination and CT of the chest) will be performed. The main question\\[s\\] it aims to answer are:\n\n* Is ultrasound examination of the lungs a more specific and sensitive method in identification of early postoperative pulmonary complications after on-pump cardiac surgical procedures, in comparison with traditional X-ray methods.\n* Does early identification of interstitial pulmonary edema (based on number of visualised B-lines in the early postoperative period), influences mid-term outcomes in this cohort of patients Participants will undergo ultrasound examination of the lungs on postoperative day 1, 3, 5 and 7 after heart surgery. Based on ultrasound findings and degree of interstitial pulmonary edema, medical (diuretics, anti-inflammatory, e.t.c) therapy will be modified.\n\nResearchers will compare this group of patients with control group, in which ultrasound examination will be performed in the same time frames, but no changes in medical management based on ultrasound findings will be made to see if timely administered medical therapy, based on ultrasound findings, can significantly improve symptoms, hospital lengths of stay and outcomes of this patients.",[189,190,28,191,192,193,194,195],"Ischemic Heart Disease","Aortic Stenosis, Severe","Mitral Stenosis","Mitral Insufficiency","Mitral Stenosis With Insufficiency","Tricuspid Insufficiency","Ascending Aortic Aneurysm",[197,198,199,200,201,202],"Ultrasound examination of the lungs","B-lines","Coronary artery bypass grafting","Heart valve surgery","Cardiopulmonary bypass","On-pump cardiac surgery","2024-12-04",{"date":62,"type":33},{"date":206,"type":33},"2024-05-15",{"date":208,"type":20},"2026-01-01",{"name":210,"class":126},"Saint Petersburg State University, Russia"]