[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-valve-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-valve-diseases":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,45,75,107,132,157,201,231,257,284],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100382350","phase-4-long-term-anticoagulation-with-oral-factor-xa-inhibitor-versus-vitamin-k-antagonist-after-mechanical-aortic-valve-replacement-100382350",false,"NCT04258488","Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement","Randomized, Evaluation of Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement","RENOVATE","Inclusion Criteria:\n\n1. Age 19 and more\n2. At least 3 months after mechanical aortic valve replacement\n3. At least one of the conditions(as defined below) is met\n\n   * The New York Heart Association (NYHA) Functional Classification I or II; or\n   * According to the Valve Academic Research Consortium(VARC)2 criteria, confirmed proper valve function: no prosthesis-patient mismatch and mean aortic valve gradient \\\u003C20 mm Hg or peak velocity \\\u003C3 m\u002Fs, AND no moderate or severe prosthetic valve regurgitation\n4. Voluntarily participated in the written agreement\n\nExclusion Criteria:\n\n1. Old-generation mechanical valve\n2. History of mechanical valve implantation in the mitral valve, pulmonary valve, or tricuspid valve\n3. Valvular atrial fibrillation(atrial fibrillation with moderate or severe mitral stenosis)\n4. Moderate to severe mitral stenosis or regurgitation\n5. History of hemorrhagic stroke\n6. Clinically overt stroke within the last 3 months\n7. Renal failure(creatinine clearance \\\u003C15mL\u002Fmin) or on hemodialysis\n8. Left ventricular dysfunction: Left ventricular ejection fraction (LVEF) ≤40%\n9. Child-Pugh B and C hepatic impairment or any hepatic disease associated with coagulopathy\n10. Clinically significant active bleeding\n11. Bleeding or hemorrhagic disorder\n12. The increased risk of bleeding due to the following reasons\n\n    1. History of gastrointestinal ulcers or active ulcerations within the last 6 months\n    2. History of intracranial or intracerebral hemorrhage within the last 6 months\n    3. Spinal cord vascular abnormalities or intracerebral vascular abnormalities\n    4. History of the brain, spinal cord, or ophthalmic surgery within the last 6 months\n    5. History of the brain or spinal cord injury within the last 6 months\n    6. History of the brain or spinal cord injury or spinal tap, major regional anesthesia, or spinal anesthesia within the last 6 months\n    7. Esophageal varices\n    8. Arteriovenous malformation\n    9. Vascular aneurysms\n    10. Malignant tumor with a high risk of bleeding\n13. Bleeding tendencies associated with overt bleeding of\n\n    1. gastrointestinal, genitourinary, respiratory tract, or colorectal cancer\n    2. cerebrovascular hemorrhage\n    3. aneurysms- cerebral, dissecting aorta\n    4. pericarditis and pericardial effusions\n    5. bacterial endocarditis\n14. Hemodynamically unstable or pulmonary embolism required thrombolysis or embolectomy\n15. Combination therapy with other anticoagulants(Unfractionated heparin(UFH), enoxaparin, dalteparin, fondaparinux, etc.) However, the following cases are permitted\n\n    * Switching anticoagulants\n    * Intravenous UFH to keep central\u002Farterial lines open\n16. Uncontrolled moderate or severe hypertension\n17. Anemia at least one among the conditions(as defined below) is met 1) Hemoglobin level \\\u003C10.0 g\u002FdL or platelet count \\\u003C 100 x 10x9\u002FL within the last 6 months 2) Diagnosed and documented ongoing anemia\n18. Infective endocarditis\n19. Hypersensitivity to the main component or constituents of Rivaroxaban or Vitamin K antagonist\n20. Positive pregnancy test results (all pregnant women should undergo urinary human chorionic gonadotropin (hCG) testing within 7 days before screening and\u002For randomization) or during pregnancy or lactation\n21. A genetic problem with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption\n22. The unsuitable condition of the protocol\n23. Actively participating in another drug or device investigational study, which has not completed the primary endpoint follow-up period\n24. Terminal illness with life expectancy \\\u003C12 months\n25. Vitamin K deficiency\n26. Alcoholic or psychical disorder\n27. Threatened abortion, eclampsia, or preeclampsia\n28. Concomitant use with antiplatelet in patients with a history of stroke or transient ischemic attack for the treatment of the acute coronary syndrome","ALL","19 Years",{"count":20,"type":21},1300,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This study evaluates the long-term anticoagulation with oral factor Xa inhibitor versus vitamin K antagonist in patients receiving a mechanical aortic valve replacement.",[27,28],"AORTIC VALVE DISEASES","Thromboembolism",[30,31],"Aortic valve replacement","Mechanical valve","RECRUITING","2026-06-23",{"date":35,"type":36},"2026-06-24","ACTUAL",{"date":38,"type":36},"2022-02-21",{"date":40,"type":21},"2028-12-30",{"name":42,"class":43},"Joon Bum Kim","OTHER",16,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100579915","sapien-3-transcatheter-aortic-valve-replacement-in-young-aortic-valve-stenosis-patients-from-china-100579915","NCT06830499","Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China","Safety, Effectiveness and Durability of Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China","Inclusion Criteria:\n\nSubjects must meet ALL of the following inclusion criteria to be eligible for participation:\n\n* 50 years of age or older but ≤70 years old at time of consent.\n* Severe AS, defined as follows:\n\n  a) For symptomatic patients: i) Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2\u002Fm2), OR mean gradient ≥40 mm Hg, OR Maximal aortic valve velocity ≥4.0 m\u002Fsec by transthoracic echocardiography at rest b) For asymptomatic patients: i) Very severe AS with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2\u002Fm2), AND maximal aortic velocity ≥5.0 m\u002Fsec, or mean gradient ≥60 mm Hg by transthoracic echocardiography at rest, OR ii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2\u002Fm2), AND a mean gradient ≥40 mm Hg or maximal aortic valve velocity ≥4.0 m\u002Fsec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR iii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2\u002Fm2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m\u002Fsec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction \\\u003C50%.\n* Tricuspid aortic valve stenosis and type-1 bicuspid aortic valve anatomy confirmed by MDCT.\n* The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.\n* Adequate iliofemoral access and acceptable level of vessel calcification and tortuosity for safe device implant.\n* The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.\n\nExclusion Criteria:\n\nSubjects are NOT eligible for participation if they meet ANY of the following exclusion criteria:\n\n* Any of the following: a. no calcification; b. challenging calcification based on physician's experience and discretion (Case Review Board would decide whether to exclude challenging calcification cases).\n* Aortic valve is a congenital unicuspid valve, congenital Type-0 or Type-2 bicuspid valve, or quadricuspid valve.\n* Severe femoral, iliac or aortic atherosclerosis, calcification, coarctation, aneurysm or tortuosity, which prevents transfemoral TAVR.\n* Evidence of an acute myocardial infarction ≤ 1 month (30 days), with evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia.\n* Need for open heart surgery (including severe aortic regurgitation, mitral regurgitation or stenosis, or tricuspid regurgitation, congenital heart disease, AF, complex coronary artery disease).\n* Aortic disease: a. bicuspid aortic valve with an ascending aorta diameter ≥ 45mm b. tricuspid aortic valve with an ascending aorta diameter ≥ 50mm.\n* Pre-existing mechanical or bioprosthetic valve in any position.\n* Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit.\n* Emergency interventional\u002Fsurgical procedures within 30 days of the valve implant procedure.\n* Hypertrophic cardiomyopathy with or without obstruction.\n* Ventricular dysfunction with LVEF \\\u003C 30%.\n* Cardiac imaging (echo, CT, and\u002For MRI) evidence of ventricular mass, thrombus or vegetation.\n* Inability (including allergy) to heparin, iodine contrast agent, warfarin or NOAC, aspirin or clopidogrel.\n* Stroke or transient ischemic attack (TIA) within 180 days of the valve implant procedure.\n* Renal replacement therapy at the time of screening.\n* Severe lung disease (FEV1 \\\u003C 50% predicted) or currently on home oxygen.\n* Estimated life expectancy \\\u003C 24 months.\n* Currently participating in an investigational drug or another device study. 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.","50 Years","70 Years",{"count":55,"type":21},450,"OBSERVATIONAL","Safety, effectiveness and durability of Sapien 3 transcatheter aortic valve replacement in young aortic valve stenosis patients from China：A multi-center, retrospective and prospective, single arm, observational study",[27,59],"Bicuspid Aortic Valve (BAV)",[61,62,63,64],"TAVR","real-world","aortic valve stenosis","Sapien 3","2026-05-21",{"date":67,"type":36},"2026-05-27",{"date":69,"type":36},"2025-04-24",{"date":71,"type":21},"2031-06-30",{"name":73,"class":43},"Xijing Hospital",4,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100622105","soft-foam-dressings-for-pressure-injury-prevention-of-cardiac-surgery-100622105","NCT07379294","Soft Foam Dressings for Pressure Injury Prevention of Cardiac Surgery","Effectiveness of Using Soft Foam Dressings in Preventing Pressure Injuries During Cardiac Surger","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Scheduled to undergo cardiac surgery under general anesthesia\n* Use of cardiopulmonary bypass (CPB) during surgery\n* Expected surgical duration greater than 4 hours\n* Intact skin without pre-existing pressure injury prior to surgery\n\nExclusion Criteria:\n\n* Surgical position other than supine\n* Long-term bedridden status prior to hospital admission\n* Altered consciousness or inability to cooperate\n* History of stroke with residual limb weakness","18 Years",{"count":84,"type":21},80,[86],"NA","The purpose of this study is to evaluate whether the application of soft foam dressings can reduce the occurrence of surgery-related pressure injuries among patients undergoing cardiac surgery. Specifically, this research aims to investigate differences in pressure injury outcomes before and after the intervention, and to assess the preventive effectiveness of soft foam dressings as an adjunctive skin-protection strategy.",[89,90,91,92,93,94,95,27,96],"CAD - Coronary Artery Disease","CABG","Valve Disease, Heart","Aortic Diseases","Valve Heart Stenosis","Aortic Aneurysm","Mitral Disease","Aortic Dissection","NOT_YET_RECRUITING","2026-05-11",{"date":100,"type":36},"2026-05-14",{"date":102,"type":21},"2026-05-31",{"date":104,"type":21},"2027-05-30",{"name":106,"class":43},"Shih,Wen-Chi",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100627558","a-prospective-multicenter-observational-study-evaluating-safety-and-effectiveness-of-sapien-3-transcatheter-aortic-valve-replacement-for-type-0-bicuspid-aortic-valve-stenosis-patients-in-china-100627558","NCT07450196","A Prospective, Multicenter, Observational Study Evaluating Safety and Effectiveness of SAPIEN 3 Transcatheter Aortic Valve Replacement for Type-0 Bicuspid Aortic Valve Stenosis Patients in China","ASCENT","Inclusion Criteria:\n\n* Age ≥50 years, and after thorough physician-patient discussion and shared decision-making, willing to undergo or accept TAVR.\n* Severe AS, defined as follows:\n\n  a) For symptomatic patients: i) Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2\u002Fm2), OR mean gradient ≥40 mm Hg, OR Maximal aortic valve velocity ≥4.0 m\u002Fsec by transthoracic echocardiography at rest b) For asymptomatic patients: i) Very severe AS with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2\u002Fm2), AND maximal aortic velocity ≥5.0 m\u002Fsec, or mean gradient ≥60 mm Hg by transthoracic echocardiography at rest, OR ii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2\u002Fm2), AND a mean gradient ≥40 mm Hg or maximal aortic valve velocity ≥4.0 m\u002Fsec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR iii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2\u002Fm2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m\u002Fsec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction \\\u003C50%.\n* Type-0 bicuspid aortic valve anatomy confirmed by multi-detector computed tomography (MDCT).\n* The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.\n* Adequate iliofemoral access and acceptable level of vessel calcification and tortuosity for safe device implant.\n* The study patient has provided written informed consent.\n\nExclusion Criteria:\n\n* Challenging calcification based on physician's experience and discretion\n* Aortic valve is a congenital unicuspid valve, congenital Type-1 or Type-2 bicuspid valve, tricuspid or quadricuspid valve\n* Severe femoral, iliac or aortic atherosclerosis, calcification, coarctation, aneurysm or tortuosity, which prevents transfemoral TAVR\n* Need for open heart surgery (including severe aortic regurgitation, mitral regurgitation or stenosis, or tricuspid regurgitation, congenital heart disease, AF, complex coronary artery disease)\n* Pre-existing mechanical or bioprosthetic valve in any position\n* Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit\n* Emergency interventional\u002Fsurgical procedures within 30 days of the valve implant procedure\n* Hypertrophic cardiomyopathy with obstruction\n* Ventricular dysfunction with LVEF \\\u003C 30%\n* Cardiac imaging (echo, CT, and\u002For MRI) evidence of ventricular mass, thrombus or vegetation\n* Renal replacement therapy at the time of screening\n* Estimated life expectancy \\\u003C 12 months\n* Currently participating in an investigational drug or another device study. 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.",{"count":115,"type":21},170,"In China, bicuspid aortic valve (BAV) represents a significantly high proportion of the transcatheter aortic valve replacement (TAVR) population. The application of TAVR in patients with BAV is challenging due to complex anatomy. To date, no prospective study has evaluated the Sapien 3 TAVR in patients with Type-0 BAV.",[118,27],"Aortic Stenosis",[120,61,121],"Balloon-expandable transcatheter heart valve","aortic stenosis","2026-05-03",{"date":124,"type":36},"2026-05-07",{"date":126,"type":21},"2026-04-15",{"date":128,"type":21},"2029-08-31",{"name":130,"class":43},"Chinese Academy of Medical Sciences, Fuwai Hospital",1,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":131},"100633277","self-expanding-hydra-transcatheter-heart-valve-thv-series-versus-balloon-expandable-devices-for-valve-in-valve-transcatheter-aortic-valve-implantation-tavi-for-patients-with-failed-surgical-aortic-bioprosthesis-100633277","NCT07524595","Self-Expanding Hydra Transcatheter Heart Valve (THV) Series Versus Balloon-Expandable Devices for Valve-In-Valve Transcatheter Aortic Valve Implantation (TAVI) for Patients With Failed Surgical Aortic Bioprosthesis.","Randomised Comparison of Self-Expanding Hydra THV Series Versus Balloon-Expandable Devices for Valve-In-Valve Transcatheter Aortic Valve Implantation (TAVI) for Patients With Failed Surgical Aortic Bioprosthesis: REVIVAL Trial","REVIVAL","\"Inclusion Criteria\":\n\n1. Male or Female patient ≥18 years of age\n2. Severe hemodynamic valve deterioration of a surgically implanted bioprosthetic aortic valve, including severe valve stenosis and\u002For severe valve regurgitation, as determined by the Heart Team assessment\n3. Patients eligible for transfemoral TAVI with both study THV platforms per heart team consensus.\n4. TAVI (with or without fracture of surgical valve) is suitable with commercially available sizes of both Hydra and Sapien\u002FMyvall BEVs.\n5. Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethics Committee and is willing to comply with all protocol-required (follow-up) evaluations.\n\n\"Exclusion criteria\":\n\n1. Patients unwilling to provide an informed consent, or whose legal representative object to their participation in the study\n2. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in woman of child-bearing potential according to local practice)\n3. Patients with non-transfemoral TAVI access.\n4. Surgical or transcatheter valve in mitral position (mitral rings are not an exclusion)\n5. Patients who had received the Bentall procedure.\n6. Patients with active bacterial endocarditis or ongoing sepsis ≤6 months prior to the index procedure\n7. Echocardiographic evidence of intracardiac mass, thrombus or vegetation\n8. Acute myocardial infarction ≤30 days before the intended TAVI procedure\n9. Known hypersensitivity or contraindication to antithrombotic therapy (or inability to be anticoagulated during the procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated\n10. Patients with severe left ventricular dysfunction and ejection fraction \\\u003C30% or hemodynamic instability requiring inotropic agent or mechanical support.\n11. Patients with significant renal insufficiency (serum creatinine \\>3.0 mg\u002FdL (265.5μmol\u002FL)) and\u002For end stage renal disease requiring chronic dialysis\n12. Patients who are at very high risk of coronary obstruction (e.g., VIVID classification IIB, IIIB, IIIC) and are judged by the heart team to require upfront leaflet laceration (e.g. Basilica or Unicorn procedure) or chimney or snorkel stenting as part of the TAVI procedure.\n13. Any planned surgical or peripheral procedure to be performed in next 30-day after the index procedure\n14. Life expectancy \\\u003C12 months due to non-cardiac co-morbid conditions including carcinomas, chronic liver disease, chronic renal disease or chronic end-stage pulmonary disease",{"count":141,"type":21},111,[86],"This is a prospective, randomised, international, multicentre, open-label, investigator-initiated study in patients undergoing valve-in-valve Transcatheter Aortic Valve Implantation (TAVI) for failed surgical aortic bioprosthesis. A total of 111 patients will be randomized in a 2:1 ratio, with 74 patients assigned to self-expanding Hydra THV Series and 37 patients assigned to BEV (Sapien THV Series and MyVal THV Series).",[27,145,146,147],"Valve-in-valve Procedures","Surgical Valve Replacement","Valve Disease, Aortic","2026-04-05",{"date":150,"type":36},"2026-04-13",{"date":152,"type":21},"2026-04",{"date":154,"type":21},"2027-08",{"name":156,"class":43},"National University of Ireland, Galway, Ireland",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":165,"sex":17,"minAge":166,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":170,"conditions":171,"keywords":183,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":131},"100629594","expanded-studies-on-the-scapis-stockholm-reexamination-cohort-100629594","NCT07476703","Expanded Studies on the SCAPIS Stockholm Reexamination Cohort","Expanded Studies of Risk Factors for Pulmonary-, Liver-, and Cardiovascular Disease in the SCAPIS 2 Stockholm Reexamination","SCAPIS-ReEx","Inclusion Criteria: Subjects already included in the main \u002F general SCAPIS reexamination study in Stockholm.\n\nExclusion Criteria: Inability to provide consent.",true,"56 Years","74 Years",{"count":169,"type":21},1400,"The Swedish CArdioPulmonary bioImage Study (SCAPIS) is a unique, large-scale national research initiative involving 30,000 randomly selected individuals aged 50-64, recruited between 2014 and 2018. The study is a collaborative effort among six university hospitals across Sweden. A follow-up study, SCAPIS 2, is conducted for half of the original participants. In Stockholm, 2,500 individuals will be re-examined at Danderyd University Hospital and Karolinska Institutet.\n\nSCAPIS 2 includes a core set of examinations involving blood sampling, questionnaires, and imaging. In addition to these, complementary local investigations are conducted to enable more detailed research questions. This protocol describes the additional studies conducted in the Stockholm cohort. All complementary assessments aim to identify risk factors for current and future lung, liver, and cardiovascular diseases.:\n\nEXTENDED SAMPLING: Saliva and Blood Samples with Blood Cell Isolation. EXTENDED QUESTIONNAIRES: Dyspnea, Sleep, Respiratory Infections, and Dental Health.\n\nEXTENDED IMAGING AND PHYSIOLOGICAL MEASUREMENTS Cardiac Ultrasound and Abdominal Aortic Measurements. Liver Elastography. Vascular Stiffness by cuff-based pulse wave analysis and Photoplethysmography (PPG). Valvular and Vascular Calcification by CT imaging.",[172,173,27,174,175,176,177,178,179,180,181,182],"Coronary Artery Disease","Arterial Stiffness, Blood Pressure","Mitral Valve Stenosis and\u002For Insufficiency","Heart Failure","Pulmonary Disease, Chronic Obstructive (COPD)","Steatohepatitis","Inflammation Biomarkers","Lipid Profile","Oral Microbiota","MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease","Metabolic Associated-dysfunction Steatohepatitis (MASH)",[184,185,186,187,188,189,190,191],"coronary artery disease","arterial stiffness","MASLD","COPD","inflammation","dyslipidemia","aortic aneurysm","oral microbiota","2026-03-12",{"date":194,"type":36},"2026-03-17",{"date":196,"type":36},"2024-04-08",{"date":198,"type":21},"2026-08-30",{"name":200,"class":43},"Danderyd Hospital",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":17,"minAge":209,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":22,"phases":212,"briefSummary":213,"conditions":214,"keywords":217,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":74},"100578960","phase-4-transcatheter-treatment-of-pure-aortic-regurgitation-with-vitaflow-liberty-system-100578960","NCT06818084","TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System","Transcatheter Treatment of Pure Aortic Regurgitation With VitaFlow Liberty System: a Prospective, Multicenter Study","TRAMPERS","Inclusion Criteria Age ≥ 60 years. Symptomatic moderate-to-severe or greater isolated aortic regurgitation.\n\nAsymptomatic moderate-to-severe or greater isolated aortic regurgitation meeting at least one of the following criteria:\n\nLVEF ≤ 55% (measured by biplane Simpson's method); LVESD \\> 50 mm ; LVESDi \\> 22 mm\u002Fmm²； LVESVi \\> 45mL\u002Fm2 Anatomical suitability for TAVR as assessed by the heart team. Provision of written informed consent by the patient or their legal guardian, with agreement to the treatment plan and willingness and ability to comply with all required follow-up assessments.\n\nExclusion Criteria Incomplete coronary revascularization. Less than 30 days of guideline-directed medical therapy at maximally tolerated doses.\n\nLife expectancy \\\u003C 1 year. LVEF \\\u003C 45%. eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m². Known allergy or contraindication to required medications (e.g., aspirin, clopidogrel, warfarin) or contrast media.\n\nAny condition that precludes contrast-enhanced CT. Concurrent moderate-to-severe or severe valvular heart disease other than aortic regurgitation.\n\nPoor patient compliance, unable to complete follow-up as required. Any other condition that, in the investigator's judgment, would make the patient unsuitable for the study.","60 Years",{"count":211,"type":21},120,[24],"This study is a prospective, multicenter, non-randomized controlled trial, planning to enroll 180 patients with pure native aortic regurgitation. On the basis of standardized medical therapy, patients will be assigned in a 1:1 ratio to undergo transfemoral transcatheter aortic valve replacement (TF-TAVR) . This prospective, multicenter trial aims to evaluate the safety and effectiveness of transfemoral TAVR using the VitaFlow™ self-expanding valve system compared to dedicated transcatheter devices in patients with PNAR.\n\nThe primary endpoint is a composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure, myocardial Infarction, and requiring dialysis or valve reoperation at 12 months post-procedure.\n\nSecondary endpoints include procedure-related complications, long-term clinical events, patient functional status and quality of life, bioprosthetic valve imaging follow-up, echocardiographic parameters, and treatment costs. All endpoint definitions conform to the Valve Academic Research Consortium-3 (VARC-3) criteria",[27,215,216],"Aortic Regurgitation","Transcatheter Aortic Valve Replacement (TAVR)",[218,219,220,221],"pure aortic regurgitation","Transcatheter aortic valve replacement (TAVR)","hypoattenuated leaflet thickening","reduced leaflet motion","2026-01-27",{"date":224,"type":36},"2026-01-30",{"date":226,"type":36},"2025-04-29",{"date":228,"type":21},"2027-11-30",{"name":230,"class":43},"Ruijin Hospital",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"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":240,"type":21},560,[86],"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.",[27,244,245,246],"Aortic Valve Stenosis and\u002For Insufficiency","Aortic Valve Regurgitation","Aortic Valve Replacement","2025-08-11",{"date":249,"type":36},"2025-08-19",{"date":251,"type":21},"2025-10-21",{"date":253,"type":21},"2027-03-15",{"name":255,"class":256},"Emblok, Inc.","INDUSTRY",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":17,"minAge":264,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":22,"phases":267,"briefSummary":268,"conditions":269,"keywords":271,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"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":266,"type":21},50,[86],"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.",[27,270,245],"Aortic Valve Stenosis",[272,245,273,274],"Heart Valve Diseases","Aortic Valve Disease","Polymeric Aortic Valve","2025-08-08",{"date":277,"type":36},"2025-08-14",{"date":279,"type":21},"2025-11-15",{"date":281,"type":21},"2027-12-30",{"name":283,"class":256},"Suzhou Hearthill Medical Technology Co.,LTD",{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":290,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":22,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":131},"100600457","early-feasibility-study-of-surgical-implantation-of-a-polymer-prosthetic-mitral-and-aortic-valve-100600457","NCT07097740","Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve","A Prospective Early Feasibility Clinical Study of Surgical Implantation of a Polymer Prosthetic Heart Valve","POLYVALVE-FIH","Inclusion Criteria:\n\n* Adults requiring surgical replacement of either mitral or aortic valve\n* Capable of undergoing cardiopulmonary bypass\n* Able to tolerate anticoagulation therapy\n* Able to understand study purpose, willing to provide informed consent and comply with follow-up\n\nExclusion Criteria:\n\n1. History of previous cardiac valve surgery or percutaneous valve replacement, including surgical aortic or mitral valve replacement (excluding Percutaneous Balloon Mitral Valvuloplasty \\[PBMV\\], which is permitted).\n2. Requirement for urgent or emergency cardiac surgery.\n3. Planned concurrent aortic valve surgery or combined valve procedure (e.g., simultaneous aortic and mitral valve surgery).\n4. Scheduled coronary artery bypass graft (CABG) during the same admission.\n5. Anticipated need for additional non-valve cardiac surgery within 12 months.\n6. Active systemic infection, including pneumonia or infective endocarditis.\n7. Intracardiac thrombus detected on echocardiography or imaging.\n8. Stroke or transient ischemic attack within the prior 3 months.\n9. Myocardial infarction, unstable coronary syndrome, or coronary revascularization within the prior 3 months.\n10. Severe comorbidities with expected life expectancy \\\u003C12 months, including Child-Pugh C liver disease, end-stage malignancy, or advanced pulmonary disease.\n11. Participation in another interventional clinical trial involving investigational devices or drugs.\n12. Anatomical risk factors such as ascending aortic aneurysm (≥50 mm), bicuspid aortic valve with ascending aorta ≥45 mm, or other high-risk features identified on imaging.\n13. Left ventricular ejection fraction (LVEF) ≤35%, indicating severe systolic dysfunction.\n14. Severe renal insufficiency, e.g., estimated GFR \\\u003C30 mL\u002Fmin\u002F1.73 m² or requirement for chronic dialysis.\n15. Coagulopathy or active bleeding disorders, e.g., INR \\>1.5 without anticoagulation therapy.\n16. Hematologic abnormalities: hematocrit \\\u003C30%, hemoglobin \\\u003C100 g\u002FL, platelet count \\\u003C100 × 10⁹\u002FL, or WBC \\\u003C4 × 10⁹\u002FL or \\>10 × 10⁹\u002FL.\n17. History of substance abuse, chronic alcoholism, or significant psychiatric illness impairing study compliance.\n18. Preoperative or intraoperative anatomical unsuitability of the valve apparatus or cardiac structure.\n19. Known allergy or hypersensitivity to polyurethane, polyester, or sulfonate-based biomaterials used in the valve prosthesis.\n20. Withdrawal from the study after valve implantation (such participants are not allowed to re-enroll).",{"count":5,"type":21},[86],"The goal of this clinical trial is to explore the early feasibility, initial safety, and efficacy of surgical implantation of a polymer prosthetic heart valve in patients requiring either mitral valve replacement or aortic valve replacement.\n\nThe main question it aims to answer is:\n\n\\-- What is the rate of valve-related complications, including thromboembolism, valve thrombosis, severe perivalvular leak, severe bleeding, and endocarditis, at 12 months post-operation?\n\nParticipants will undergo:\n\n* Surgical implantation of a polymer prosthetic valve (mitral valve replacement for mitral valve group and aortic valve replacement for aortic valve group).\n* Regular follow-up visits at 30 days, 3-6 months, and 12 months post-operation to evaluate clinical outcomes, including echocardiographic assessment and clinical event monitoring.",[27,296,118,215,297,298],"Mitral Valve Disease","Mitral Stenosis","Mitral Regurgitation","2025-07-24",{"date":301,"type":36},"2025-07-31",{"date":303,"type":36},"2025-06-27",{"date":305,"type":21},"2027-06",{"name":307,"class":256},"Mitrassist Lifesciences Limited Co., Ltd."]