[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-stenosis-severe\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-stenosis-severe":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,43,78,113,138,172,192,213,245],{"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":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100632969","valvosoft-outcomes-registry-for-real-world-evidence-100632969",false,"NCT07520591","Valvosoft Outcomes Registry for Real-World Evidence","Prospective Post-Market Clinical Follow-Up Registry to Assess the Long-term Safety and Effectiveness for the Treatment of Severe Symptomatic Aortic Valve Stenosis Using Valvosoft Non-Invasive Ultrasound Therapy","VALOR-PMCF","Inclusion Criteria:\n\n1. Suffering from calcific sSAS according to the definition presented in the current and applicable Guidelines for the management of valvular heart disease.\n2. Not recommended by the local heart team for immediate TAVR\u002FSAVR, or refusing such an intervention.\n3. Willing to provide a written informed consent prior to participating in this Registry.\n4. Able to comply with the follow up schedule or other Study requirements.\n\nExclusion Criteria:\n\n1. Prosthetic aortic valve;\n2. Chest deformity preventing optimal contact between Patient's chest and Valvosoft Applicator;\n3. Thoracic injured skin, presence of scar(s) and\u002For burn(s) on thorax that may be in contact or close proximity with Valvosoft Applicator;\n4. Pregnant or breastfeeding Patient.","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","The VALvosoft Outcomes Registry for Real-World Evidence (VALOR-PMCF) is a prospective, multicenter, single-arm post-market clinical follow-up (PMCF) registry designed to evaluate the long-term safety and effectiveness of the Valvosoft® non-invasive ultrasound therapy (NIUT) device in patients with severe symptomatic calcific aortic stenosis (sSAS).\n\nValvosoft® delivers focused, high-intensity, short-duration ultrasound pulses to the aortic valve via a trans-thoracic approach, inducing non-thermal mechanical softening of calcified valve tissue.\n\nThis registry will enroll up to 200 participants across approximately 20 clinical sites in Europe following CE marking. Participants will be followed from discharge through 12 months post-procedure to assess clinical outcomes, quality of life, echocardiographic parameters, and safety events in a real-world setting.",[25,26,27,28,29],"Aortic Valve Disease","Aortic Stenosis, Severe","Aortic Valve Calcification","Ultrasound Therapy","Heart Failure","NOT_YET_RECRUITING","2026-04-09",{"date":33,"type":34},"2026-04-14","ACTUAL",{"date":36,"type":21},"2026-05-30",{"date":38,"type":21},"2028-06-30",{"name":40,"class":41},"Cardiawave SA","INDUSTRY",6,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100561922","a-study-to-obtain-imaging-data-in-40-patients-having-transcatheter-aortic-valve-implantation-tavi-100561922","NCT06596460","A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI)","Single Centre Prospective Study to Obtain Data to Train an Algorithm for Prediction of Outcome in Transcatheter Aortic Valve Implantation (TAVI)","CONTINUUM-CT","Inclusion Criteria:\n\n* ≥ 18 years of age\n* Symptomatic, degenerative, tricuspid, severe aortic stenosis\n* TTE derived aortic valve area (AVA) of ≤ 1.0 cm2 (or indexed effective orifice area (EOAi) ≤ 0.6 cm2 \u002Fm2)\n* TTE derived AV mean gradient ≥ 40 mmHg or peak jet velocity ≥ 4.0 m\u002Fs or Doppler Velocity Index (DVI) ≤ 0.25\n* CT TAVI deemed of good quality (as per standard operating procedure) within past 6 months\n* TTE of good quality within past 6 months as defined by:\n\n  * Doppler signal across the aortic valve and LVOT is a clear and artifact-free waveform\n  * Correct alignment to the blood flow direction to ensure accurate velocity measurements\n  * Following measurements available\n  * Continuous-wave Doppler (CW) across the aortic valve\n  * AV Vmax, AV Vmean, AV peak gradient (MaxPG), AV mean gradient (meanPG), AV Velocity-Time integral (VTI), heart rate (HR);\n  * Pulse-wave Doppler (PW) across the LVOT\n  * LVOT Vmax, LVOT Vmean, LVOT MaxPG, LVOT meanPG, LVOT VTI;\n  * 2D LVOT diameter in plax view.\n* In sinus rhythm at time of any TTE or CT scans\n* Undergone a technically successful elective TAVI as defined by the operator using a Edwards Sapien 3 Ultra (20, 23, 26 or 29 mm):\n\n  * Position and height as planned\n  * Trivial aortic regurgitation\n  * No vascular or other complications prolonging discharge\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C6 months\n* Rockwood frailty score \\>6\n* Mixed aortic valve disease with predominant aortic regurgitation that is at least moderate.\n* Moderate-severe mitral regurgitation and\u002For mitral stenosis.\n* Congenital unicuspid or congenital bicuspid aortic valve as verified by echocardiography or CT\n* Previous TAVI or Aortic Valve Replacement (AVR)\n* Left Ventricular Ejection Fraction (LVEF) \\\u003C 50%\n* On or planned oral anticoagulation\n* Chronic severe renal failure (estimated glomerule filtration rate (eGFR)) less than 30 mL\u002Fmin\u002F1.73m2 by the MDRD equation or requiring dialysis)\n* Evidence of an acute myocardial infarction within 30 days prior to index procedure\n* Untreated clinically significant coronary artery disease requiring revascularization\n* Blood dyscrasias as defined: leukopenia (WBC \\\u003C 3000mm3), acute anaemia (Hb \\\u003C 9g\u002FdL), thrombocytopenia (platelet count \\\u003C 50,000 cells\u002Fmm3); history of bleeding diathesis or coagulopathy\n* Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation\n* Those lacking capacity to consent or are deemed vulnerable adults\n* Requires permanent pacemaker\n* Pregnancy or the possibility of pregnancy as reported by the participant.",{"count":52,"type":21},40,"INTERVENTIONAL",[55],"NA","The aim of this study is to learn if the Computed Tomography scan (CT scan) and heart echo scan TransThoracic Echo scan (TTE or heart echo scan) taken before a Transcatheter Aortic Valve Implantation (TAVI) procedure can be used to predict how the new TAVI valve will perform in the future.\n\nTo do this the investigators need the usual CT scan before and a new CT scan after the TAVI valve has been put in. At present a CT scan after TAVI procedure is not routinely done. Male and female patients with severe Aortic Stenosis (AS) will be asked to take part.\n\nThe data from the scans along with routine measures that are taken will be used to assess if there has been any deterioration in the valve at six months.\n\nThe scan data collected will be used in a computer programme. This programme will be trained to predict TAVI valve performance.\n\nThe main purpose of this study is to collect the CT scan data before and after the TAVI procedure.\n\nThe study aims to answer:\n\n• Can the investigators obtain additional CT imaging data and other data before and after TAVI to enable the prediction of valve performance?\n\nParticipants will be asked if they would have another CT scan 6 months after their TAVI procedure, during their routine follow up.",[26,58],"Aortic Valve Stenosis",[60,61,62,63,64,65],"Heart","Valve","Implantation","Transcatheter","CT","Computerised Tomography","RECRUITING","2025-09-01",{"date":69,"type":34},"2025-09-03",{"date":71,"type":34},"2024-07-09",{"date":73,"type":21},"2026-09-12",{"name":75,"class":76},"Barts & The London NHS Trust","OTHER",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":53,"phases":87,"briefSummary":88,"conditions":89,"keywords":97,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":77},"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":86,"type":21},186,[55],"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.",[90,26,91,92,93,94,95,96],"Ischemic Heart Disease","Aortic Insufficiency","Mitral Stenosis","Mitral Insufficiency","Mitral Stenosis With Insufficiency","Tricuspid Insufficiency","Ascending Aortic Aneurysm",[98,99,100,101,102,103],"Ultrasound examination of the lungs","B-lines","Coronary artery bypass grafting","Heart valve surgery","Cardiopulmonary bypass","On-pump cardiac surgery","2024-12-04",{"date":106,"type":34},"2024-12-09",{"date":108,"type":34},"2024-05-15",{"date":110,"type":21},"2026-01-01",{"name":112,"class":76},"Saint Petersburg State University, Russia",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":77},"100555190","timing-and-typology-of-conduction-disturbances-during-tavi-100555190","NCT06508866","Timing And Typology of ConducTIon disturbanCes During TAVI","Timing And Typology of ConducTIon disturbanCes During TAVI: the TACTIC-TAVI Registry","TACTIC-TAVI","Inclusion Criteria:\n\nPatients successfully undergoing transcatheter aortic valve implantation for native severe aortic stenosis.\n\n\\-\n\nExclusion Criteria:\n\n1. Presence of previously implanted permanent cardiac pacemaker.\n2. Valve-in-valve procedures.\n3. No pre-procedural electrocardiogram is available.\n4. No pre-procedural contrast CT TAVI is available.\n5. Enrollment in another clinical trial.\n6. Patients aged less than 18 years old.\n7. Patients who do not consent for their data to be included in the registry.\n8. Failed transcatheter aortic valve deployment. -",{"count":122,"type":21},490,"The TACTIC-TAVI registry aims to collect information about a consecutive cohort of patients undergoing transcatheter aortic valve insertion. The registry is international, multi-centre and observational. The registry is planned to continue until the calculated sample size is achieved.",[26],[126,127,128],"TAVI","Pacemaker","aortic stenosis","2024-07-19",{"date":131,"type":34},"2024-07-22",{"date":133,"type":34},"2023-02-01",{"date":135,"type":21},"2024-12-31",{"name":137,"class":76},"Istituto Clinico Humanitas",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":53,"phases":147,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"100286027","partner-3-trial---aortic-valve-in-valve-100286027","NCT03003299","PARTNER 3 Trial - Aortic Valve-in-Valve","A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3\u002FSAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve","Inclusion Criteria:\n\n1. Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and\u002For ≥ moderate insufficiency.\n2. Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.\n3. NYHA Functional Class ≥ II.\n4. Heart Team agrees the patient is low to intermediate risk.\n5. Heart Team agrees valve implantation will likely benefit the patient.\n6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion)\n2. Severe regurgitation (\\> 3+) or stenosis of any other valve\n3. Failing valve has moderate or severe paravalvular regurgitation\n4. Failing valve is unstable, rocking, or not structurally intact\n5. Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.\n6. Increased risk of embolization of THV\n7. Known bioprosthetic valve with residual mean gradient \\> 20 mmHg at the end of the index procedure for implantation of the original valve\n8. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (Transfemoral)\n9. Anatomical characteristics that would preclude safe access to the ascending aorta (Transaortic)\n10. Anatomical characteristics that would preclude safe access to the apex (Transapical)\n11. Evidence of an acute myocardial infarction ≤ 30 days before enrollment\n12. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days prior to the index procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion.\n13. Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation\n14. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states\n15. Untreated clinically significant coronary artery disease requiring revascularization\n16. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment\n17. Emergency interventional\u002Fsurgical procedures within 30 days prior to the procedure\n18. Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-up from the procedure\n19. Hypertrophic cardiomyopathy with obstruction\n20. LVEF \\\u003C 30%\n21. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation\n22. Inability to tolerate or condition precluding treatment with antithrombotic\u002Fanticoagulation therapy during or after the valve implant procedure\n23. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication\n24. Stroke or transient ischemic attack within 90 days of enrollment\n25. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment\n26. Renal insufficiency and\u002For renal replacement therapy at the time of screening\n27. Active bacterial endocarditis within 180 days of the procedure\n28. Patient refuses blood products\n29. Estimated life expectancy \\\u003C 24 months\n30. Positive urine or serum pregnancy test in female subjects of childbearing potential\n31. Currently participating in an investigational drug or another device study",{"count":146,"type":21},125,[55],"This study will assess the safety and effectiveness of the SAPIEN 3\u002FSAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.",[150,26],"Aortic Stenosis",[152,153,154,155,128,156,157,158,159,160,161],"SAPIEN 3","PARTNER 3","cardiovascular disease","heart disease","SAVR","TAVR","failing surgical valve","failing bioprosthetic valve","failing valve","SAPIEN 3 Ultra","2024-05-08",{"date":164,"type":34},"2024-05-10",{"date":166,"type":34},"2017-01-05",{"date":168,"type":21},"2038-04",{"name":170,"class":41},"Edwards Lifesciences",51,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":77},"100526058","exercise-cmr-in-plf-lg-as-100526058","NCT06129799","Exercise CMR in (p)LF-LG AS","Exercise CMR in (Paradoxical) Low-flow Low-gradient Aortic Stenosis","Inclusion Criteria:\n\n* paradoxical or conventional severe low-flow low-gradient aortic stenosis\n\nExclusion Criteria:\n\n* CMR incapable device\n* unable to undergo 40 min scan (can not lie flat, claustrophobia)\n* renal insufficiency (eGFR \\\u003C30 ml\u002Fmin\u002F1.73m²)\n* allergy against contrast agent\n* unable to exercise in supine position",{"count":180,"type":21},100,"Patient with paradoxical or conventional low-flow low-gradient aortic stenosis on echocardiographic assessment will undergo physiological exercise-stress CMR in addition to guideline recommended surveys prior to TAVR.",[26],"2023-11-09",{"date":185,"type":34},"2023-11-13",{"date":187,"type":34},"2023-11-01",{"date":189,"type":21},"2026-12-31",{"name":191,"class":76},"University of Göttingen",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":77},"100519410","outcome-prediction-in-patients-with-aortic-stenosis-after-tavi-100519410","NCT06043180","Outcome Prediction in Patients With Aortic Stenosis After TAVI","Observational Study of Outcome Prediction in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI) for Severe Symptomatic Aortic Stenosis (PREDICT-TAVI).","PREDICT-TAVI","Inclusion Criteria:\n\n* Patients with symptomatic severe aortic stenosis (AVA \\\u003C1.0 cm2\u002F\\\u003C0.6cm2\u002Fm2 or mean gradient \\>40mmHg or jet velocity \\>4.0 m\u002Fs).\n\nExclusion Criteria:\n\n* Extracardiac limitations of ambulatory exercise, cardiac rehab opt out, non-transfemoral TAVI, haemodynamic instability\u002Fcardiogenic shock, LVEF \\\u003C40%, poorly controlled AF, severe COPD, primary pulmonary hypertension, evidence of cardiac amyloid, more than moderate concomitant valvular heart disease other than aortic stenosis, previous sternotomy, permanent pacemaker implant, patients enrolled in another study where participation would involve deviation from either protocol.",{"count":201,"type":21},69,"This study will investigate changes right ventricular function and functional recovery metrics after transcatheter aortic valve implantation",[26],"2023-09-12",{"date":206,"type":34},"2023-09-21",{"date":208,"type":21},"2023-10-01",{"date":210,"type":21},"2027-02-01",{"name":212,"class":76},"Guy's and St Thomas' NHS Foundation Trust",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":221,"targetDuration":223,"studyType":22,"phases":4,"briefSummary":224,"conditions":225,"keywords":232,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":244},"100480463","tavis-registry---trilogy-heart-valve-system-for-management-of-patients-with-aortic-valve-disease-100480463","NCT05536310","TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease","Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease: Patient Registry and Post-Market Clinical Follow-up Study","TAVIS","Inclusion Criteria:\n\n1. Patients who have signed ICF and are indicated by their doctors to be treated with Trilogy Heart Valve System in line with the medical standard of care\n2. Patients with symptomatic severe aortic regurgitation (AR) or symptomatic, severe aortic stenosis (AS), who are at high risk for SAVR as documented by the heart team and Heart Team agrees that patient can undergo SAVR for \"bail out\"\u002Fto address unfavorable circumstances if necessary\n3. Patients 18 years of age or older\n4. Patient is willing to participate in the study, provides signed Informed Consent\u002FData Authorization Form and authorizes the sharing of data in the study\n5. The subject and treating physician agree the subject will return for all required post-procedure follow-up visits\n\nExclusion Criteria:\n\n1. Patients who have known hypersensitivity or contraindication to Nitinol (titanium and\u002For nickel), an anti-coagulation\u002Fanti-platelet regimen or contrast medium that cannot be managed with premedication\n2. Patients who have active bacterial endocarditis or other active infections\n3. Pediatric (\\\u003C18 years) and\u002For pregnant\u002Fnursing patients\n4. Congenital\u002Ffunctional unicuspid, bicuspid or quadricuspid native aortic valve morphology\n5. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant\n6. Echocardiographic evidence of current left heart thrombus\n7. Hypertrophic cardiomyopathy with or without obstruction.\n8. Access vessel characteristics that would preclude safe placement of the JenaValve 20Fr introducer sheath, such as severe obstructive calcification, severe tortuosity, or vessel diameter \\\u003C7mm.",{"count":222,"type":21},600,"5 Years","To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).",[58,226,227,228,25,229,230,231,26],"Aortic Valve Regurgitation","Aortic Valve Stenosis With Insufficiency","Constriction, Pathologic","Heart Valve Diseases","Cardiovascular Diseases in Old Age","Ventricular Outflow Obstruction",[233,25,234,226],"Trilogy","Transcatheter aortic valve replacement (TAVR)","2023-01-10",{"date":237,"type":34},"2023-01-11",{"date":239,"type":21},"2023-03",{"date":241,"type":21},"2027-10",{"name":243,"class":41},"JenaValve Technology, Inc.",3,{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":254,"conditions":255,"keywords":256,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":77},"100452965","mri-in-randomised-cohorts-of-asymptomatic-as-100452965","NCT05178368","MRI in Randomised Cohorts of Asymptomatic AS","Impact of Early Valve Replacement on Myocardial Scar in Asymptomatic Aortic Stenosis: an Observational MRI Study of Randomised Cohorts","Inclusion Criteria:\n\n1. Willing to and able to consent\n2. Participant in an RCT randomising patients with asymptomatic severe AS to early AVR vs standard care\n3. Severe aortic stenosis, as defined by original trial's inclusion criteria\n4. Asymptomatic at the time of randomisation in the RCT\n5. Willingness to have 1-2 cardiac MRI scan(s)\n\nExclusion Criteria:\n\n1. Contra-indication to MRI.\n2. eGFR \\\u003C30.\n3. Severe claustrophobia (precluding MRI).",{"count":253,"type":21},230,"Aortic stenosis is narrowing of the aortic valve, and is the commonest type of valve disease requiring surgery. Current guidelines recommend waiting till patients develop symptoms (chest pain, breathlessness and dizzy spells\u002Ffainting) before possible open heart surgery to replace the valve is offered. However, studies using detailed 'MRI' scanning of the heart have shown that up to half of the patients already have 'scarring' in the heart by the time symptoms develop. Furthermore, scarring is not fully reversed even after surgery and is associated with worse outcome. This suggests that some patients are being offered treatment too late. Two randomised trials in the UK (EASY AS and EVOLVED) are currently investigating if valve replacement before symptoms will result in better survival. The aim of this study is to compare the effect of early valve replacement versus waiting for symptoms, on the amount of scarring in the heart. The investigators want to know if early treatment leads to less overall scarring at the end, and leads to better quality of life and recovery after surgery. The investigators will invite participants of the EASY AS and EVOLVED trials to have 1-2 MRI heart scans: at recruitment and 3 years after being randomly allocated to early aortic valve replacement vs 'watchful waiting'. The investigators will also assess the impact of the two treatment approaches on quality of life, disability-free survival (using questionnaires) and recovery after surgery. The results from this project will increase understanding of the results of the main trials, and lead to improved selection of patients with aortic stenosis who are likely to benefit from early surgery.",[26],[257,258,259],"myocardial fibrosis","cardiac magnetic resonance imaging","late gadolinium enhancement","2021-12-16",{"date":262,"type":34},"2022-01-05",{"date":264,"type":34},"2021-07-28",{"date":266,"type":21},"2031-09-01",{"name":268,"class":76},"University of Leicester"]