[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-stenosis":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,85,0,25,[9,41,77,111,143,173,202,232,253,277,299,322,343,354,381,404,429,450,474,502,532,560,582,607,633],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100053784","phase-2-to-establish-whether-dapagliflozin-and-spironolactone-in-patients-with-severe-aortic-stenosis-undergoing-aortic-valve-replacement-result-in-better-left-ventricular-mass-regression-myocardial-health-and-patient-reported-outcomes-100053784",false,"NCT07539259","To Establish Whether Dapagliflozin and Spironolactone in Patients With Severe Aortic Stenosis Undergoing Aortic Valve Replacement, Result in Better Left Ventricular Mass Regression, Myocardial Health and Patient Reported Outcomes","Regression in Left Ventricular Hypertrophy and Fibrosis in Aortic Stenosis - a Randomised Controlled Trial","RELIEF-AS","Inclusion Criteria:\n\n* Participants ≥ 18 years\n* Left Ventricular Ejection Fraction (LVEF) ≥40%.\n* Diagnosed with severe symptomatic aortic stenosis\\* by a cardiologist or cardiac surgeon.\n\n  o Severity of AS follows international guideline criteria \\[38\\], namely at least one out of: effective orifice area \\[EOA\\] \\\u003C1.0 cm2, indexed EOA of ≤0.6 cm2\u002Fm2, peak velocity ≥4.0 m\u002Fs or mean gradient \\>40 mmHg. \\* including severe low flow low gradient AS\n* Referred for surgical or transcatheter AVR (SAVR or TAVI).\n* Able to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Current use or intolerance or hypersensitivity to MRAs or SGLT2-inhibitors.\n* Hyperkalaemia (K\\>4.5 mmol\u002FL)\n* Significant renal impairment (eGFR \\\u003C 45 mL\u002Fmin\u002F1.73m²)\n* Severe hepatic insufficiency\n* Concomitant severe other valve lesion (severe MR, MS or AR)\n* Contraindications to MRAs including:\n\n  * Addison's disease.\n  * Acute porphyrias.\n  * Receiving potassium-sparing diuretics, potassium supplements or strong inhibitors of CYP 3A4 (for example. itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone).\n* Contraindications to SGLT2-inhibitors including:\n\n  * Active urinary tract infections.\n  * At risk or with a history of diabetic ketoacidosis\n* Type 1 or Type 2 Diabetes on insulin.\n* Concomitant diagnosis affecting trial participation or life expectancy of less than two years as evaluated by the treating clinician.\n* Contraindications to MRI (e.g. non-conditional cardiac pacemaker, severe claustrophobia, inability to lie flat: participants who do not meet local safety rules for MRI). NB: Conditional pacemakers\u002FICDs, if implanted after the baseline scan, are not an exclusion, depending on local expertise.\n* Ongoing participation in another CTIMP interventional clinical trial (i.e. drug trial), will not be permitted. Participation in any other trial will need to be discussed with the trial investigators.\n* Significant comorbidities that would contraindicate participation, including uncontrolled hypertension, or recent myocardial infarction (within 3 months prior to screening).\n* Pregnancy or breastfeeding, or females of childbearing potential not using an effective method of contraception.\n* Any other medical or psychiatric condition that would interfere with participation or compliance with study procedures as determined by the Principal Investigator (PI).\n\n  * As evidenced by features of decompensated cirrhosis e.g. hepatic encephalopathy, ascites, jaundice or markedly deranged liver blood tests e.g. elevated bilirubin, serum albumin \\\u003C30 or deranged clotting","ALL","18 Years",{"count":21,"type":22},445,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This trial aims to improve the heart health of people with a narrowed aortic valve called aortic stenosis (AS) who then have aortic valve replacement (AVR) by assessing the change in the mass of the left ventricle.\n\nEven after an AVR in many patients the heart is still unable to pump as well and can lead to heart failure.\n\nThis study will assess if medication used in other causes of heart failure can help participants having an AVR recover better. Researchers will compare two drugs, dapagliflozin and spironolactone, that have been shown to help patients with heart failure who do not have AS, to see if taking one or both medicines together will help patients with AS.\n\nThere will be four treatment arms: dapagliflozin, spironolactone, dapagliflozin and spironolactone together, and standard of care. These will be taken as one tablet of each IMP per day for 12 months.\n\nParticipants will have approximately four follow up visits, dependent on the treatment arm - those in an arm with spironolactone will have an extra safety follow up visit.\n\nThese medicines might help patients after AVR by reducing heart muscle thickness and scarring.",[28],"Aortic Stenosis","NOT_YET_RECRUITING","2026-07-10",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":22},"2026-12",{"date":37,"type":22},"2030-02-28",{"name":39,"class":40},"University College, London","OTHER",{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":58,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100504659","mechanisms-of-disease-progression-in-aortic-stenosis---the-modas-study-100504659","NCT05851209","Mechanisms Of Disease Progression in Aortic Stenosis - the MODAS Study","Evaluation of Immunologic and Image Morphologic Parameters to Predict Disease Progression in Patients With Moderate Aortic Valve Stenosis","Inclusion Criteria:\n\n* The patient has an acquired (tricuspid) moderate aortic valve stenosis, which is the reason for regular outpatient cardiological care.\n* The subject has been informed verbally and in writing about the study and has given written consent to participate in this study.\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* The subject has contraindications for the performance of a magnetic resonance imaging or computed tomography (e.g., severe arrhythmias , contrast agent intolerance, a pacemaker, or severe renal insufficiency or severe renal insufficiency or claustrophobia).\n* Presence of only mild or already high-grade acquired tricuspid Aortic valve stenosis\n* Patient with bicuspid aortic valve\n* Inability to follow the instructions of study personnel\n* Lack of written informed consent",{"count":49,"type":22},938,"OBSERVATIONAL","Biomarkers and mechanisms in the progression of aortic valve stenosis are sometimes not sufficiently understood. The current project will take into account image morphological and immunological aspects that predict the development of hemodynamically relevant aortic valve stenosis in order to identify high-risk patients and to develop further therapeutic options.",[28,53,54,55,56,57],"Imaging","Pathogenesis","Disease Progression","Aortic Valve Calcification","Genetics",[59,60,61,62,63,64,65],"severe aortic stenosis","disease progression","pathogenesis of degenerative aortic stenosis","early detection","Cardiovascular magnet resonance","Transthoracal echocardiography","computertomography","RECRUITING","2026-06-26",{"date":69,"type":33},"2026-06-30",{"date":71,"type":33},"2023-07-01",{"date":73,"type":22},"2031-07",{"name":75,"class":40},"Heinrich-Heine University, Duesseldorf",3,{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":18,"minAge":84,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":76},"100614216","capture-2-controlled-arterial-protection-to-ultimately-remove-embolic-material-100614216","NCT07276711","CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material","Controlled Arterial Protection to Ultimately Remove Embolic Material","Clinical Inclusion Criteria\n\n1. Age ≥ 22 years at the time of consent\n2. Meets FDA-approved indications for elective transfemoral self-expanding transcatheter aortic valve replacement (TAVR) procedure on a native or non-native (valve-in-valve) aortic valve. Note: Due to Neurologist availability and importance of capturing the neurological assessments, procedures must be performed Monday-Thursday.\n3. Left ventricular ejection fraction ≥ 30% as confirmed by echocardiogram\n4. Willing and able to provide written informed consent and written HIPAA authorization prior to initiation of study procedures\n5. Willing and able to comply with the protocol-specified procedures and assessments\n\nImaging Inclusion Criteria\n\n1. Echocardiogram including left ventricular ejection fraction ≥ 30% within 6 months (180 days) prior to the index procedure and prior to randomization to confirm adequate cardiac function.\n2. Subjects must undergo a computed tomography angiography (CTA) scan within 6 months (180 days) prior to the index procedure and prior to randomization to confirm anatomic compatibility with the study device and the control device. Subjects must meet the following anatomical inclusion criteria:\n\nEmStop Angiographic (CTA) Inclusion Criteria 1. Subject anatomy is compatible with correct device positioning with:\n\n* Ascending aorta length ≥8 cm\n* Femoral and iliac artery minimal lumen diameter of ≥ 8.0 mm\n* Ascending aorta\u002Faortic arch diameter is ≥25 or ≤40 mm.\n* Ascending aorta or aortic arch exhibits ≤ Grade 1 atheromatous disease and limited wall calcification\n\nSentinel Angiographic (CTA) Inclusion Criteria\n\n1\\. Subject anatomy, excluding bovine arch anatomy, is compatible with correct device positioning with:\n\n* Artery diameter is 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery\n* Arterial stenosis \\\u003C70% in either the left common carotid artery or the brachiocephalic artery\n* Brachiocephalic or left carotid artery without significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium\n* Adequate blood flow to the right upper extremity\n* Access vessels without excessive tortuosity\n\nExclusion Criteria:\n\n1. Requires use of a balloon-expandable transcatheter aortic valve for the index procedure\n2. Documented history of stroke or transient ischemic attack (TIA) within the prior 6 months, or any prior stroke with a permanent major disability or deficit (National Institute of Health Stroke Scale \\[NIHSS\\] \\>1 at baseline)\n3. Left ventricular ejection fraction \\\u003C30%, cardiogenic shock, or hypotension requiring inotropes or mechanical circulatory support, within 3 months prior to index procedure\n4. Acute myocardial infarction (MI) within 30 days of the planned index procedure\n5. Planned to undergo any other open cardiac surgical or left heart interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 30 days prior to the TAVR procedure. The need for a postoperative pacemaker implant after TAVR is not exclusionary.\n6. Renal failure, defined as estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\n7. Hypercoagulable state that cannot be corrected by additional periprocedural heparin\n8. History of intolerance, allergic reaction, or contraindication to any of the study medications, including heparin, aspirin, clopidogrel, or a sensitivity to contrast media or anesthesia that cannot be adequately pre-treated\n9. Undergoing therapeutic thrombolysis\n10. History of bleeding diathesis or major coagulopathy\n11. Hepatic failure (Child-Pugh class C)\n12. Active endocarditis or ongoing systemic infection, defined as fever (\\>38°C) and\u002For WBC \\>15,000 IU\n13. Known allergy to any materials used in the EmStop system (e.g., nitinol)\n14. Currently participating in another drug or device clinical study\n15. Known or suspected to be pregnant, or is lactating; women of child bearing age must have a negative serum or urine pregnancy test within 48 hours prior to the index study procedure\n16. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)\n17. Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study","22 Years",{"count":86,"type":22},663,[88],"NA","The objective of this study is to demonstrate safety and efficacy of the EmStop Embolic Protection System when used as indicated to capture and remove thrombus\u002Fdebris during self-expanding transcatheter aortic valve replacement (TAVR) procedures.",[91,28,92],"Aortic Valve Stenosis","Aortic Valve Disease",[94,95,96,97,98,99,100,101],"Transcatheter aortic valve replacement (TAVR)","Cerebral embolic protection device","Stroke","Cerebrovascular accident","Neuroprotection","Aortic valve disease","Aortic valve stenosis","Aortic stenosis","2026-06-24",{"date":67,"type":33},{"date":105,"type":33},"2026-05-12",{"date":107,"type":22},"2028-05",{"name":109,"class":110},"EmStop Inc","INDUSTRY",{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":18,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":122,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":142},"100488920","phase-2-a-multicenter-trial-assessing-the-impact-of-lipoproteina-lowering-with-pelacarsen-tqj230-on-the-progression-of-calcific-aortic-valve-stenosis-100488920","NCT05646381","A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis","A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis [Lp(a)FRONTIERS CAVS]","Inclusion Criteria:\n\n* Male and female ≥50 to \\\u003C80 years of age at Screening Part II\n* Lp(a) ≥175 nmol\u002FL at the screening visit, measured at the Central laboratory\n* Mild or moderate calcific aortic valve stenosis\n* At the randomization visit, participant must be optimally treated for existing CV risk factors\n\nExclusion Criteria:\n\n* Severe calcific aortic valve stenosis\n* Uncontrolled hypertension\n* History of malignancy of any organ system\n* History of hemorrhagic stroke or other major bleeding\n* Platelet count ≤ LLN\n* Active liver disease or hepatic dysfunction\n* Significant kidney disease\n* Pregnant or nursing women\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply","50 Years","80 Years",{"count":121,"type":22},502,[25],"The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.",[28],[126,127,128,129,130,131,132,100,101],"Cardiovascular","Lipoprotein(a)","Lp(a)","Hyperlipoproteinemia(a)","Calcific aortic valve stenosis","TQJ230","Pelacarsen","2026-06-19",{"date":135,"type":33},"2026-06-23",{"date":137,"type":33},"2024-03-07",{"date":139,"type":22},"2030-03-12",{"name":141,"class":110},"Novartis Pharmaceuticals",140,{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":150,"targetDuration":152,"studyType":50,"phases":4,"briefSummary":153,"conditions":154,"keywords":158,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":172},"100638082","derivation-and-validation-of-the-aortic-valve-echocardiographic-calcium-score-to-confirm-severe-aortic-stenosis-the-echo-avcs-study-100638082","NCT07620925","Derivation and Validation of the Aortic Valve Echocardiographic Calcium Score to Confirm Severe Aortic Stenosis: the Echo-AVCS Study","Echo-AVCS","Inclusion Criteria:\n\n* Age \\> 18 years old\n* Clinical indication for standard transthoracic echocardiography.\n* Clinical indication for cardiac CT with available calcium score.\n* 3-month time interval between transthoracic echocardiography and cardiac CT.\n* Able to give informed consent.\n\nExclusion Criteria:\n\n* Patients with inadequate transthoracic echocardiographic images.\n* Poor quality cardiac CT, inadequate for standard calcium score assessment.\n* Patients with known prior stents and\u002For coronary artery bypass grafts.\n* Patients with known previous percutaneous or surgical aortic valve replacement.\n* Patients with active or a history of endocarditis.\n* Patients with congenital heart defects (other than isolated bicuspid aortic valve).",{"count":151,"type":22},250,"1 Year","The Echo-AVCS Study is an investigator-initiated, prospective, multicenter observational study designed to derive and validate an artificial intelligence (AI)-based echocardiographic aortic valve calcium score (Echo-AVCS) for confirming severe aortic stenosis (AS). Transthoracic echocardiography (TTE) is the standard imaging modality for assessing AS severity; however, discrepancies between valve area and transvalvular gradient measurements may complicate diagnosis, particularly in low-flow or discordant AS presentations. Cardiac computed tomography (CT)-derived aortic valve calcium scoring is currently used to resolve diagnostic uncertainty, but it involves additional cost and radiation exposure. This study will enroll consecutive adult patients undergoing clinically indicated TTE and cardiac CT with calcium scoring performed within 3 months. Standardized echocardiographic images will be centrally analyzed using dedicated AI-based image segmentation and machine learning methods to quantify aortic valve calcification directly from TTE images. CT-derived aortic valve calcium score will serve as the reference standard. The primary objective is to derive and validate the Echo-AVCS score for identifying severe AS. Secondary objectives include determination of sex-specific diagnostic thresholds, correlation with CT calcium volume, association with symptoms and NYHA class, and evaluation of prognostic associations with aortic valve replacement, heart failure hospitalization, cardiovascular events, and mortality at 1-year follow-up.",[28,155,156,157],"Chronic Coronary Syndrome","Calcific Aortic Valve Disease","Calcific Aortic Stenosis",[101,159,160,161,162],"Low-flow","Aortic valve calcium score","Echocardiography","Cardiac-CT","2026-06-03",{"date":165,"type":33},"2026-06-04",{"date":167,"type":33},"2026-03-01",{"date":169,"type":22},"2027-12-31",{"name":171,"class":40},"Azienda Ospedaliera \"Sant'Andrea\"",5,{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":201},"100578954","phase-4-application-of-tavi-at-experienced-interventional-cardiac-centers-without-on-site-cardiac-surgery-atlas-study-100578954","NCT06818006","Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)","Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery","ATLAS","Inclusion Criteria:\n\n* Severe symptomatic AS reviewed and accepted for Transfemoral (TF) TAVI by an established Heart Team\n* Obtained informed consent\n\nExclusion Criteria:\n\n* Ambiguous aortic annular sizing on CT measurement deemed to increase the risk of valve embolization\n* Hostile aortic root on CT for TAVI implantation defined by, but not limited to:\n* High risk LVOT with a dimension significantly smaller than the annulus and\u002For extensive calcification\n* Features that increase the risk of coronary artery occlusion including inadequate coronary artery height and\u002For shallow coronary sinuses in the setting of a significant coronary artery territory at risk (accounting for prior CABG)\n* High risk STJ anatomy defined by inadequate height and\u002For diameter and\u002For excessive calcification\n* Vascular anatomy with increased risk of ascending aorta trauma (i.e. combinations of existing ascending aortic aneurysm, and\u002For unfolded aorta and\u002For extensive tortuosity and\u002For excessive iliofemoral calcification)\n* GFR \\\u003C15, excluding patients on dialysis\n* Life expectancy less than 3 years\n* Any factor precluding 1-year follow-up",{"count":182,"type":22},600,[184],"PHASE4","The purpose of this study is to see if having the Transcatheter Aortic Valve Replacement (TAVR) procedure done in a hospital with onsite cardiac surgery available or not, makes a difference on participant outcomes. Current standard of care is to have this procedure done in a hospital with onsite cardiac surgery available.\n\nHypothesis\n\nThe investigators hypothesize that the TAVR in experienced interventional cardiac centers without on-site cardiac surgery will be safe and effective. Although this is happening clinically in select regions internationally, this change in the clinical application of TAVI requires a rigorous assessment of safety with a robust randomized trial and multicenter international collaboration.",[28,187],"Severe Aortic Stenosis",[28,189,190,191],"TAVR","TAVI","Sever aortic stenosis","2026-06-01",{"date":194,"type":33},"2026-06-02",{"date":196,"type":22},"2026-08-01",{"date":198,"type":22},"2030-12",{"name":200,"class":40},"University of Alberta",2,{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":212,"conditions":213,"keywords":217,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":4},"100640284","evaluation-of-a-management-algorithm-for-tavi-patients-with-concomitant-mitral-or-tricuspid-regurgitation-100640284","NCT07623083","Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation","Evaluation of a Treatment Algorithm for the Management of TAVI Patients With Significant Concomitant Mitral or Tricuspid Regurgitation","MASTER-TAVI II","Inclusion Criteria:\n\n* Age \\>18 years.\n* Patients with severe AS undergoing transarterial TAVI.\n* Concomitant significant MR and\u002For TR (≥3+).\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C1 year due to noncardiac conditions.\n* Any prior mitral or tricuspid valve surgery.\n* Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.\n* Active endocarditis.\n* Subjects in whom transesophageal echocardiography is contraindicated or high risk.",{"count":211,"type":22},300,"Aortic stenosis is a condition in which the aortic valve becomes narrow and does not open properly, making it harder for the heart to pump blood to the body. Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure commonly used to treat this condition, especially in older patients or patients at high surgical risk.\n\nMany patients undergoing TAVI also have leakage of the mitral valve and\u002For tricuspid valve. These valve problems can cause symptoms such as shortness of breath, fatigue, swelling, heart failure, and repeated hospitalizations. Patients with multiple valve diseases generally have worse outcomes and are more difficult to treat.\n\nIn some patients, mitral or tricuspid valve leakage improves after TAVI because the heart works better once the aortic valve has been treated. However, in other patients, the leakage remains severe and continues to affect their health and quality of life. New minimally invasive treatments are now available to repair or replace the mitral and tricuspid valves, but doctors still do not know the best order or timing for these procedures.\n\nThis study aims to evaluate a treatment algorithm for patients with severe aortic stenosis and significant mitral and\u002For tricuspid valve leakage. The proposed approach follows current clinical guidelines and uses a stepwise strategy. Patients will first undergo TAVI, followed by reassessment of the mitral and tricuspid valves. If important valve leakage persists after TAVI, additional minimally invasive procedures may be considered to treat the mitral or tricuspid valve.\n\nThe study will include patients with severe aortic stenosis and moderate-to-severe or severe mitral and\u002For tricuspid regurgitation. Researchers will collect information about patient symptoms, heart imaging results, procedures, hospitalizations, quality of life, and clinical outcomes during follow-up.\n\nThe main goal of the study is to evaluate whether this staged treatment approach is safe, feasible, and effective in improving patient outcomes. Researchers will also assess whether the strategy can reduce hospitalizations for heart failure and improve symptoms, daily functioning, and quality of life.\n\nThe results of this study may help doctors better manage patients with multiple valve diseases and provide a more personalized and structured treatment approach for this complex group of patients.",[28,214,215,216],"Mitral Regurgitation","Tricuspid Regurgitation","Transcatheter Aortic Valve Implantation (TAVI)",[101,218,219,220,221,222,223],"Transcatheter aortic valve implantation (TAVI)","Multivalvular heart disease","Mitral regurgitation","Tricuspid regurgitation","Structural heart disease","Valve disease management algorithm","2026-05-28",{"date":163,"type":33},{"date":227,"type":22},"2026-06-05",{"date":229,"type":22},"2034-06-05",{"name":231,"class":40},"Josep Rodes-Cabau",{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":239,"enrollmentInfo":240,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":252},"100575829","redo-transcatheter-aortic-valve-replacement-for-transcatheter-aortic-valve-failure-100575829","NCT06777368","REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE","RESTORE","Inclusion Criteria:\n\n* BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR\n\nExclusion Criteria:\n\n* BVF due solely to paravalvular regurgitation\n* Active endocarditis\n* Untreated acute valve thrombosis\n* Life-expectancy less than 1-year\n* Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable\n* Participating in another study that may influence the outcome of this study","105 Years",{"count":241,"type":22},225,"The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).",[28],"2026-05-27",{"date":224,"type":33},{"date":247,"type":33},"2025-02-06",{"date":249,"type":22},"2027-11",{"name":251,"class":110},"Medtronic Cardiovascular",71,{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":23,"phases":263,"briefSummary":264,"conditions":265,"keywords":266,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":76},"100637150","transcatheter-aortic-valve-implantation-without-on-site-cardiac-surgery-100637150","NCT07604402","TRanscatheter Aortic-Valve Implantation Without On-site Cardiac Surgery","TRanscatheter Aortic-Valve Implantation Without On-site Cardiac Surgery Broadened Access","TRACS-PRIME","Inclusion criteria\n\n1. Severe aortic stenosis\n2. Indication to TAVI confirmed by the Heart Team\n\nAND one of the following enrichment criteria:\n\n1. Prohibitive operative risk\n2. High surgical risk as defined as STS score \\>8%\n3. Porcelain aorta or severely atherosclerotic aorta\n4. Frailty\u002FReduced physical performance\n5. Severe liver disease\u002Fcirrhosis\n6. Hostile chest and\u002For internal mammalian artery or other critical conduit(s) crossing midline and\u002For adhering to the posterior table of the sternum\n7. Severe pulmonary hypertension and\u002For severe right ventricular dysfunction\n8. Age ≥85 years\n9. Severe Chronic Obstructive Pulmonary Disease (COPD) The criteria listed above qualify the patient for eligibility in the study if present immediately after the heart team has indicated TAVI. However, this does not exclude patients without these criteria from entering the study if the heart team's evaluation still considers their risk\u002Fbenefit profile appropriate for inclusion in the protocol.\n\nExclusion criteria\n\n1. Unsuitable for transfemoral TAVI\n2. Emergent TAVI\n3. Non-cardiovascular comorbidity reducing life expectancy to \\\u003C1 year\n4. Any factor precluding 1-year follow-up\n5. Refusal of informed consent",{"count":262,"type":22},1612,[88],"TRACS-PRIME is a prospective, randomized, multicenter clinical trial evaluating whether transcatheter aortic valve implantation (TAVI) can be performed safely and effectively in selected hospitals without on-site cardiac surgery, when appropriate patient selection, experienced operators, advanced imaging, and established transfer pathways are available. The study will include patients with severe symptomatic aortic stenosis who have an indication for TAVI confirmed by a multidisciplinary Heart Team. Eligible patients will be randomized to undergo TAVI either in a center without on-site cardiac surgery or in a center with on-site cardiac surgery. All procedures will be performed according to current standards of care by experienced TAVI operators. The main purpose of the study is to determine whether TAVI performed in centers without on-site cardiac surgery is not inferior to TAVI performed in centers with on-site cardiac surgery with respect to clinical outcomes at 1 year. The primary clinical outcome includes death from any cause, stroke, or hospitalization related to the procedure or the implanted valve. The study will also assess safety outcomes, including valve-related death and major procedural or technical complications. Participants will be followed after hospital discharge to assess clinical events, safety, and longer-term outcomes. An independent committee blinded to treatment allocation will review clinical events, and an independent Data Safety Monitoring Board will monitor patient safety during the trial.",[28],[190,267],"on-site cardiac surgery","2026-05-26",{"date":270,"type":33},"2026-05-29",{"date":272,"type":33},"2026-05-25",{"date":274,"type":22},"2034-05-25",{"name":276,"class":40},"University Hospital of Ferrara",{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":286,"conditions":287,"keywords":288,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":201},"100570949","identifying-biological-markers-of-cardiovascular-events-in-patients-with-aortic-stenosis-or-tavi-100570949","NCT06713889","Identifying Biological Markers of Cardiovascular Events in Patients With Aortic Stenosis or TAVI","Bio-TAVI","Inclusion Criteria:\n\n* Patients \\>=18 years of age\n* Patient with symptomatic or asymptomatic severe or moderately severe aortic stenosis (according to the recommendations of the European Society of Cardiology - ESC).\n* No opposition.\n\nExclusion Criteria:\n\n* Conjunctive heart disease (e.g. amyloidosis).\n* Presence of a contraindication to TAVI.\n* Impossibility of giving the subject informed information.\n* Privation of civil rights (curatorship, tutorship, protection of justice).",{"count":285,"type":22},125,"Aortic stenosis, a common cardiovascular disease, is pathophysiologically associated with a chronic inflammatory myocardial reaction and fibrosis leading to cardiac dysfunction and impaired coronary perfusion. These elements may precede the onset of symptoms. The assessment of inflammatory and fibrosis factors (in particular by means of biomarkers) in patients with aortic stenosis will make it possible to identify asymptomatic patients at greater risk who could benefit from intervention earlier. This is part of a personalised medicine adapted to the patient.\n\nPatients will be recruited during their TAVI (Transcatheter Aortic Valve Implantation) assessment consultation. If the patient agrees to take part in the study, information relating to routine care procedures will be collected (patient history, clinical examinations, electrocardiogram, echography, coronary angiography, TAVI procedure if applicable, biology).\n\nOutside of routine care, a biocollection will be established (serum, plasma), quality of life questionnaires will be carried out and adverse events will be collected where present.\n\nPatients will be divided into 3 groups according to the indication for TAVI (Group A - symptomatic severe aortic stenosis with indication for TAVI, Group B - asymptomatic severe aortic stenosis without indication for TAVI, Group C - asymptomatic moderate aortic stenosis without indication for TAVI).\n\nThe main objective is to compare the levels of biomarkers of inflammation and fibrosis between the 3 groups at each sampling time common to all three groups between inclusion and 1-year follow-up.",[28],[101,190,289,290],"Cardiology","Biomarkers","2026-05-22",{"date":244,"type":33},{"date":294,"type":33},"2024-12-19",{"date":296,"type":22},"2030-06",{"name":298,"class":40},"Hospices Civils de Lyon",{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":23,"phases":309,"briefSummary":310,"conditions":311,"keywords":312,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":318,"leadSponsor":320,"locationsCount":201},"100637068","cerebral-microembolization-during-transcatheter-aortic-valve-implantation-comparing-balloon-expandable-and-self-expanding-valves-100637068","NCT07614100","Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves","Cerebral Microembolization During Transcatheter Aortic Valve Implantation: A Randomized Study Comparing Balloon-expandable and Self-expanding Valves","MICROTAVI","Inclusion Criteria:\n\n* Age 18 years or older\n* Severe symptomatic aortic valve stenosis\n* Clinical indication for transcatheter aortic valve implantation\n* Feasibility of transcranial Doppler ultrasound monitoring\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Recent stroke or transient ischemic attack\n* Significant cerebrovascular disease preventing reliable transcranial Doppler -assessment\n* Previous aortic valve implantation\n* Active endocarditis\n* Pregnancy or breastfeeding",{"count":308,"type":22},80,[88],"This study will compare the amount of cerebral microembolization during transcatheter aortic valve implantation (TAVI) between two commonly used types of transcatheter aortic valves: balloon-expandable valves and self-expanding valves.\n\nCerebral microembolization refers to small particles or material that may travel to the brain during the procedure. These signals can be detected using transcranial Doppler ultrasound, a non-invasive method for monitoring blood flow in the brain. Although clinically apparent stroke after TAVI is relatively uncommon, small silent brain lesions may occur, and their mechanisms are not fully understood.\n\nAdult patients with severe symptomatic aortic valve stenosis who are scheduled for TAVI will be included. Participants will be randomly assigned to receive either a balloon-expandable or a self-expanding valve, both of which are established and routinely used treatment options. Transcranial Doppler monitoring will be performed before, during, and after the procedure to record the number of microembolic signals. The study will also record neurological events and procedural characteristics, such as procedure duration and the need for balloon dilatation.\n\nThe aim of the study is to determine whether the type of valve is associated with a different burden of cerebral microembolization during TAVI. The results may help improve understanding of procedural factors related to cerebral embolization and may support future strategies for reducing neurological risk in patients undergoing TAVI.",[28],[313,91,314],"Transcatheter Aortic Valve Replacement","Microembolism","2026-05-21",{"date":270,"type":33},{"date":192,"type":22},{"date":319,"type":22},"2027-02-01",{"name":321,"class":40},"Ivan Zeljkovic",{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":329,"targetDuration":152,"studyType":50,"phases":4,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":342},"100638048","active-post-market-surveillance-of-innovative-devices-for-valvular-heart-disease-100638048","NCT07605624","Active Post-Market Surveillance of Innovative Devices for Valvular Heart Disease","An Active Post-Market Surveillance Study Assessing the Real-World Clinical Applicability, Long-Term Safety, and Effectiveness of Innovative Medical Devices for Valvular Heart Disease","Inclusion Criteria:\n\n* Patients with valvular heart disease (VHD) receiving treatment with prosthetic aortic valve replacement systems (transcatheter and surgical valves), transcatheter mitral valve edge-to-edge repair (TEER) systems, or transcatheter tricuspid valve annuloplasty systems\n* Age ≥ 18 years\n* Patients who voluntarily participate in the study and sign the informed consent form\n* Willing and able to comply with follow-up requirements",{"count":330,"type":22},5500,"This prospective, multicenter, observational cohort study aims to establish a post-market registry framework to evaluate the real-world clinical applicability, long-term safety, and effectiveness of innovative heart valve devices in China.",[28,333,214,215],"Aortic Regurgitation","2026-05-18",{"date":268,"type":33},{"date":337,"type":22},"2026-05-10",{"date":339,"type":22},"2029-01-31",{"name":341,"class":40},"Beijing Anzhen Hospital",1,{"id":344,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":23,"phases":347,"briefSummary":26,"conditions":348,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":351,"completionDateStruct":352,"leadSponsor":353,"locationsCount":4},"100634405","Inclusion Criteria:\n\n* Participants ≥ 18 years\n* LVEF ≥40%.\n* Diagnosed with severe symptomatic AS by the clinical care team.\n\n  o Severe AS defined according to international guideline criteria, namely at least one out of: effective orifice area \\[EOA\\] \\\u003C1.0 cm2, indexed EOA of 0.6 cm2\u002Fm2, peak velocity \\>4.0 m\u002Fs or mean gradient \\>40 mmHg.\n* Referred for surgical or transcatheter AVR (SAVR or TAVI).\n* Able to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Current use or intolerance or hypersensitivity to MRAs or SGLT2-inhibitors.\n* Hyperkalaemia (K\\>4.5 mmol\u002FL)\n* Significant renal impairment (eGFR \\\u003C 45 mL\u002Fmin\u002F1.73m²)\n* Severe hepatic insufficiency\n* Contraindications to MRAs including:\n\n  * Addison's disease.\n  * Acute porphyrias.\n  * Receiving potassium-sparing diuretics, potassium supplements or strong inhibitors of CYP 3A4 (for example. itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone).\n* Contraindications to SGLT2-inhibitors including:\n\n  * Active urinary tract infections.\n  * At risk of diabetic ketoacidosis (e.g. Type 1 diabetes mellitus)\n* Concomitant diagnosis affecting trial participation or life expectancy of less than two years.\n* History of significant arrhythmias or other cardiac conditions that would interfere with the trial outcomes.\n* Contraindications to MRI (e.g. non-conditional cardiac pacemaker, severe claustrophobia, inability to lie flat: participants who do not meet local safety rules for MRI). NB: Conditional pacemakers\u002FICDs, if implanted after the baseline scan, are not an exclusion, depending on local expertise.\n* Ongoing participation in another interventional clinical trial.\n* Significant comorbidities that would contraindicate participation, including uncontrolled hypertension, or recent myocardial infarction (within 3 months prior to screening).\n* Pregnancy or breastfeeding, or females of childbearing potential not using an effective method of contraception.\n* Any other medical or psychiatric condition that would interfere with participation or compliance with study procedures as determined by the Principal Investigator (PI).",{"count":21,"type":22},[25],[28],"2026-05-13",{"date":334,"type":33},{"date":35,"type":22},{"date":37,"type":22},{"name":39,"class":40},{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":362,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":365,"conditions":366,"keywords":367,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":201},"100629847","multicenter-study-for-the-validation-of-willem-ai-aortic-stenosis-early-diagnosis-with-ai-electrocardiogram-study-100629847","NCT07479992","Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram Study","Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram (Willem AoS-SEDAI) Study","AoS-SEDAI","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* All available 12-lead ECG with a 10 seconds minimum length on raw data digital format will be included\n* Available clinical data corresponding to each ECG to confirm patient demographics and Aortic Stenosis diagnosis\n* Available transthoracic echocardiogram (TTE) within +\u002F- 90 days of each ECG recording\n\nNo exclusion criteria are defined for this study.",true,{"count":364,"type":22},5000,"AoS-SEDAI study is an observational, multicenter, retrospective and prospective clinical study.\n\nThis study aims to assess Willem Artificial Intelligence (AI) ability to distinguish between aortic stenosis (AS) and non-AS patients from 12-lead electrocardiogram (ECG) data.",[28],[368,369,370,371,372],"artificial intelligence","electrocardiogram","deep learning","cardiac disease","aortic stenosis","2026-05-08",{"date":105,"type":33},{"date":376,"type":33},"2026-04-28",{"date":378,"type":22},"2026-07",{"name":380,"class":110},"Idoven 1903 S.L.",{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":385,"acronym":386,"eligibilityCriteria":387,"healthyVolunteers":12,"sex":18,"minAge":118,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":390,"conditions":391,"keywords":393,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":342},"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":389,"type":22},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.",[28,392],"AORTIC VALVE DISEASES",[394,189,372],"Balloon-expandable transcatheter heart valve","2026-05-03",{"date":397,"type":33},"2026-05-07",{"date":399,"type":22},"2026-04-15",{"date":401,"type":22},"2029-08-31",{"name":403,"class":40},"Chinese Academy of Medical Sciences, Fuwai Hospital",{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":23,"phases":413,"briefSummary":414,"conditions":415,"keywords":416,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":425,"leadSponsor":427,"locationsCount":342},"100610698","correlation-between-an-impedance-cardiography-test-for-decompensation-and-the-development-of-left-ventricular-replacement-fibrosis-100610698","NCT07230964","Correlation Between an Impedance Cardiography Test for Decompensation and the Development of Left Ventricular Replacement Fibrosis","Early Feasibility Study of the Correlation Between an Impedance Cardiography Test for Decompensation and the Development of Left Ventricular Replacement Fibrosis","Inclusion Criteria:\n\n* • Male or female at least 18 years of age.\n\n  * No prior history of myocardial infarction or cardiac amyloidosis.\n  * Recent CMR scan with late gadolinium enhancement or scheduled for CMR scan with late gadolinium enhancement.\n  * A history of:\n  * Moderate aortic stenosis and no replacement fibrosis OR Moderate aortic stenosis and symptoms who has replacement fibrosis OR Severe aortic stenosis with replacement fibrosis prior to aortic valve replacement.\n  * Able to comprehend and provide informed consent in English.\n  * Participants must have intact, healthy skin at the electrode application sites.\n\nExclusion Criteria:\n\n* • Under 18 years of age\n\n  * Pregnant or breastfeeding women\n  * Unable to consent\n  * Prisoners\n  * History of myocardial infarction\n  * History of cardiac amyloidosis\n  * Patients with any metal or implant such as IUD, braces, metal fragments implants in the eye, pacemakers (especially Minute Ventilation pacemakers with the MV function activated) defibrillators, or any other electronic cardiac implant.\n  * Claustrophobic or afraid or small places.\n  * Severe obesity (BMI \\> 40) that impairs accurate ICG measurement due to difficulties in electrode placement or excessive impedance.\n  * Active skin conditions, such as rashes, open wound or significant skin sensitivity at the electrode placement sites.",{"count":412,"type":22},6,[88],"The purpose of this study is to evaluate the effectiveness of impedance cardiography (ICG), the HYPERGRAPH test, in detecting left ventricular decompensation in patients with aortic stenosis, compared to cardiac magnetic resonance (CMR) imaging findings. The study aims to obtain usable ICG test data on six patients with aortic stenosis who have recently undergone CMR scans with late gadolinium enhancement, and who do not have a history of myocardial infarction or cardiac amyloidosis. The hypothesis to be tested is that the HYPERGRAPH can accurately detect left ventricular decompensation associated with replacement fibrosis obtained from CMR imaging.",[28],[417,418,372,419,420],"impedance cardiography","decompensation","fibrosis","myocardial replacement fibrosis","2026-04-30",{"date":423,"type":33},"2026-05-05",{"date":421,"type":33},{"date":426,"type":22},"2026-11-30",{"name":428,"class":110},"Dermed Diagnostics, Inc.",{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":362,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":23,"phases":439,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":342},"100552202","comparison-of-evolut-fx-versus-sapien-3-ultra-resilia-100552202","NCT06470022","Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.","Randomized Comparison of Evolut FX Versus Sapien 3 Ultra Resilia. The Compare-TAVI 2 Trial","COMPARE-TAVI","Inclusion Criteria:\n\n1. Patient more than 18 years of age.\n2. Patient eligible for both Evolut FX and Edwards Sapien 3 Ultra Resilia according to a TAVI heart team conference.\n3. The center experience for each of the valves considered should be more than 15 cases a year, and the treating physician should have implanted at least 15 of each valve used in the trial.\n4. The center volume should be more than 75 cases a year.\n5. The patient has given signed informed consent.\n6. TAVI performed via the femoral artery.\n\nExclusion Criteria:\n\nNone",{"count":438,"type":22},1346,[88],"To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.",[28],"2026-04-22",{"date":376,"type":33},{"date":445,"type":33},"2024-08-09",{"date":447,"type":22},"2036-12-01",{"name":449,"class":40},"Christian Juhl Terkelsen",{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":458,"targetDuration":459,"studyType":50,"phases":4,"briefSummary":460,"conditions":461,"keywords":462,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":470,"leadSponsor":472,"locationsCount":4},"100634455","alternative-peripheral-tavi-accesses-100634455","NCT07539909","Alternative Peripheral TAVI Accesses","The APTA (Alternative Peripheral TAVI Accesses) Registry.","APTA","Inclusion Criteria:\n\n* Males or females qualified by the \"heart team\" for TAVI procedure, without the possibility of using femoral access.\n* Possibility of TAVI procedure with peripheral access after multi-slice computed tomography analysis.\n\nExclusion Criteria:\n\n* No significant aortic stenosis\n* Cancer with a short expected survival period\n* No qualifications for TAVI",{"count":182,"type":22},"6 Months","The APTA (Alternative Peripheral TAVI Accesses) registry is an observational multi-center, retrospective and prospective study, including high and medium - risk patients with aortic stenosis (AS) contraindicates for trans-femoral TAVI, treated with TAVI thought to peripheral accesses. Upper Silesian Medical Center, Katowice and the other hospitals will be involved in the study.",[28],[463,464,372,465],"trancarotid-TAVI","transaxillary-TAVI","alternative accesses","2026-04-18",{"date":468,"type":33},"2026-04-23",{"date":399,"type":22},{"date":471,"type":22},"2026-07-01",{"name":473,"class":40},"Medical University of Silesia",{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":480,"eligibilityCriteria":481,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":482,"targetDuration":4,"studyType":23,"phases":484,"briefSummary":485,"conditions":486,"keywords":488,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":342},"100565137","transcatheter-aortic-valve-implantation-in-aortic-stenosis-cardiogenic-shock-100565137","NCT06638268","Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock","Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock - The TACTICS Study - A Randomized Controlled Trial","TACTICS","Inclusion Criteria:\n\n* Aortic valve area less than 1cm2\n\nAND\n\nCardiogenic Shock defined as:\n\n* Peripheral signs of tissue hypoperfusion (arterial blood lactate ≥2.5mmol\u002Fl) AND\n* Systolic blood pressure \\\u003C 100 mmHg and\u002For need for vasopressor therapy (dopamine\u002F norepinephrine or epinephrine) AND\n* Left ventricular ejection fraction ≤ 45%\n\nOR\n\n\\- Syncope\u002Fresuscitation (mechanical ventilation)\n\nExclusion Criteria:\n\n* Intracranial hemorrhage \\\u003C 1 month ago\n* Remaining life-expectancy \\\u003C 6 month due to other cause\n* Body mass index \\\u003C15 OR \\> 40\n* Clinical frailty score ≥6 before present worsening\n* Severe lung disease (forced expiratory volume in 1 second OR diffusion capacity of the lungs for carbon monoxide \\\u003C 25 of expected)\n* Unsuitable for TAVI prior to screening",{"count":483,"type":22},30,[88],"The goal of this clinical trial is to learn if acute transcatheter aortic valve implantation (TAVI) is superior to standard treatment (stabilization in an intensive care unit and TAVI subsequently) to treat cardiogenic shock in patients with critical severe aortic stenosis.\n\nThe main questions it aims to answer are:\n\n• Does acute TAVI increase survival compared with standard treatment?\n\nParticipants will:\n\n* Undergo either TAVI within 12 hours after admission or stabilization and TAVI 72 hours or more after admission\n* Visit an outpatient clinic and be evaluated for quality of life and heart function",[28,487],"Cardiogenic Shock",[489,487,28,490,491,492,91,313,493],"Randomized Controlled Trial","Mortality","Frailty","Quality Of Life","Transcatheter Aortic Valve Implantation","2026-04-17",{"date":442,"type":33},{"date":497,"type":33},"2024-11-25",{"date":499,"type":22},"2027-10-30",{"name":501,"class":40},"Rigshospitalet, Denmark",{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":508,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":18,"minAge":510,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":23,"phases":513,"briefSummary":514,"conditions":515,"keywords":517,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":342},"100617375","phase-4-echo-guided-vs-fluoroscopy-guided-transcatheter-aortic-valve-replacement-in-patients-with-aortic-stenosisecho-tavr-100617375","NCT07317804","Echo-Guided vs Fluoroscopy-Guided Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis（ECHO-TAVR）","Echo-Guided vs Fluoroscopy-Guided Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis","ECHO-TAVR","Inclusion Criteria:\n\n* 1\\. Patients aged 70 years or older with obvious clinical symptoms or a left ventricular ejection fraction less than 50% due to severe aortic valve stenosis (aortic valve orifice area \\\u003C 1.0 cm² or peak velocity ≥ 4.0 m\u002Fs or mean transvalvular pressure ≥ 40 mmHg); or patients with obvious clinical symptoms of low blood flow and low pressure difference aortic valve stenosis (effective aortic valve orifice area \\\u003C 1.0 cm², mean transvalvular pressure difference \\\u003C 40 mmHg, left ventricular ejection fraction \\\u003C 50%, stroke volume index \\\u003C 35 ml\u002Fm², and diagnosed as true severe aortic valve stenosis by dobutamine stress test);\n* 2\\. Patients aged 65 years ≤ age \\\u003C 70 years with severe aortic stenosis who have surgical contraindications or high risks, or have other risk factors such as post-chest radiotherapy, liver failure, diffuse severe aortic calcification, extreme weakness, etc., or patients refuse to undergo routine open-chest surgery;\n* 3\\. The patient's anatomical structure is suitable for TAVR and can tolerate transesophageal ultrasound;\n* 4\\. The patient has signed the informed consent form and is willing to participate in this study.\n\nExclusion Criteria:\n\n* 1\\. Imaging (ultrasound and\u002For CT and\u002For MRI) confirmed a lesion, thrombus or calculus in the left ventricle;\n* 2\\. Severe obstruction of the left ventricular outflow tract;\n* 3\\. Severe right ventricular dysfunction;\n* 4\\. Acute myocardial infarction within 30 days before the procedure;\n* 5\\. Active endocarditis history within 180 days before the procedure;\n* 6\\. Inappropriate aortic root anatomy (such as combined aortic dissection, excessive aortic annulus, risk of coronary artery occlusion, etc.);\n* 7\\. Severe calcification and distortion of the surgical approach;\n* 8\\. Left ventricular ejection fraction less than 20%;\n* 9\\. Other cardiac diseases that require concurrent treatment (such as severe mitral regurgitation, atrial fibrillation, etc.);\n* 10\\. History of stroke or transient ischemic attack within 90 days before the procedure;\n* 11\\. Liver cirrhosis or active liver disease;\n* 12\\. Renal insufficiency (creatinine clearance rate \\\u003C 30 mL\u002Fmin) and\u002For undergoing renal replacement therapy;\n* 13\\. Unable to tolerate anticoagulation therapy during or after the procedure;\n* 14\\. Participating in other drug or device research;\n* 15\\. Any emergency or surgical operation within 30 days before the procedure;\n* 16\\. Other severe comorbidities, even if the valve stenosis is corrected, the expected life expectancy is less than 1 year;\n* 17\\. Other conditions deemed unsuitable for TAVR surgery by the cardiac team.","65 Years",{"count":512,"type":22},212,[184],"Aortic stenosis (AS) is a common valvular heart disease whose prevalence increases markedly with age-approximately 2-4% in individuals aged 65 years and older, and up to 3.4% for severe AS in those over 75. Degenerative calcific AS predominates in high-income countries, whereas rheumatic disease remains a major cause in low-income regions. With global population aging, the disease burden of AS continues to rise.\n\nTranscatheter aortic valve replacement (TAVR\u002FTAVI), owing to its minimally invasive nature, has become an important treatment option for severe AS and selected aortic regurgitation patients, expanding from high-surgical-risk populations to those at intermediate and low risk. In recent years, the number of TAVR procedures in many regions has surpassed or approached that of surgical aortic valve replacement, and major clinical guidelines have elevated TAVR to a recommended standard therapy.\n\nConventional TAVR relies on combined fluoroscopic and echocardiographic guidance. However, perioperative complications remain frequent in elderly and high-risk patients, particularly acute kidney injury (AKI), which significantly increases short- and long-term mortality. Contrast exposure during the procedure is a major contributor to AKI; thus, clinical practice increasingly favors strategies that minimize contrast use, such as low-dose and low-kV imaging. Elevated contrast concentration in the renal tubules increases viscosity, prolongs renal exposure, and can lead to tubular injury and renal dysfunction. Continuous radiation exposure during vascular access, device positioning, valve deployment, and post-release assessment also poses safety concerns for both patients and medical staff.\n\nEchocardiography-only guidance for TAVR has therefore emerged as an attractive alternative, with the potential to replace fluoroscopy and contrast for anatomical visualization and device positioning, thereby reducing radiation exposure and contrast-related kidney injury. However, no prospective randomized study has directly compared echocardiography-only guidance with conventional fluoroscopy-plus-echocardiography guidance, and current evidence remains preliminary.\n\nTo address this gap, a randomized controlled trial was designed to evaluate whether echocardiography-only guidance is non-inferior to combined fluoroscopic and echocardiographic guidance in terms of device success, while also assessing the safety, efficacy, and clinical feasibility of both approaches.",[28,190,516],"TAVI(Transcatheter Aortic Valve Implantation)",[518,519,516,190,28,520,521],"Ultrasound-guided","Percutaneous Intervention","PAN Procedure","non fluoroscopic","2026-04-16",{"date":524,"type":33},"2026-04-21",{"date":526,"type":22},"2026-04-26",{"date":528,"type":22},"2028-07-31",{"name":530,"class":531},"China National Center for Cardiovascular Diseases","OTHER_GOV",{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":542,"conditions":543,"keywords":548,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":555,"completionDateStruct":556,"leadSponsor":558,"locationsCount":342},"100608144","delineate-prospective-100608144","NCT07197736","DELINEATE-Prospective","Deep Learning for Echo Analysis, Tracking, and Evaluation Prospective Evaluation (DELINEATE-Prospective)","DELINEATE","Inclusion Criteria:\n\n* Attending cardiologist employed by Columbia University, ColumbiaDoctors, or NewYork Presbyterian Hospital who reads transthoracic echocardiograms in the Columbia echocardiography laboratory\n* Provided informed consent to take part in the questionnaires or pivotal study\n\nExclusion Criteria:\n\n* Physician in training (cardiology fellow or advanced imaging fellow)",{"count":541,"type":22},50,"Heart disease is the leading cause of death in the United States, and echocardiography (or \"echo\") is the most common way doctors look at the heart. Echo is safe, painless, and can detect major heart problems, including weak heart pumping and valve disease.\n\nValve disease, especially aortic stenosis (narrowing) and mitral regurgitation (leakage), is common in older adults but often goes undiagnosed. While echo is the main tool for finding valve problems, it takes time, requires expert training, and results can vary between readers.\n\nRecent advances in artificial intelligence (AI), especially deep learning (DL), have shown promise in automatically analyzing heart images. However, past research hasn't fully tackled key echo techniques-like color Doppler and spectral Doppler-that are crucial for measuring how blood moves through heart valves. AI tools also face challenges in being used in everyday medical practice because of workflow issues, lack of real-world testing, and concerns about how the algorithms make decisions.\n\nAt Columbia University Irving Medical Center, researchers have built a large database of heart tests over the last six years and developed AI programs to analyze echocardiograms. The current study will test whether providing AI analysis to cardiologists in real time during echo reading can make the process faster and more consistent.",[544,545,28,546,547,333],"Valve Disease, Aortic","Mitral Regurgitation (MR)","Valvular Heart Disease","Tricuspid Regurgitation (TR)",[368,370,549,550,551,552,372],"valvular heart disease","echocardiography","cardiovascular disease","mitral regurgitation","2026-04-14",{"date":522,"type":33},{"date":399,"type":22},{"date":557,"type":22},"2028-10-01",{"name":559,"class":40},"Columbia University",{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":23,"phases":568,"briefSummary":569,"conditions":570,"keywords":572,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":342},"100614339","star-trial-siegel-transcatheter-aortic-valve-replacement-in-patients-with-symptomatic-severe-aortic-stenosis-100614339","NCT07278310","STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)","Inclusion Criteria:\n\nSubjects are eligible for entry in this study if ALL the following conditions are met:\n\n1. Age ≥ 18 years\n2. Symptomatic, severe native calcific aortic stenosis in subjects at low, intermediate or high surgical risk AVA ≤ 1.0 cm2 or AVA index ≤ 0.6 cm2\u002Fm2 or Jet velocity ≥ 4.0 m\u002Fs or mean gradient ≥ 40 mmHg or dimensionless Index \\\u003C0.25\n3. New York Heart Association Functional Class ≥ 2\n4. Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team (composed of an experienced interventional cardiologist and an experienced cardiac surgeon)\n5. Eligible for transfemoral delivery of a TAVR\n6. Native aortic annulus suitable for safe placement of Siegel 23mm, 26mm or 29 mm transcatheter heart valve. Preprocedural measurements by TTE and CT of aortic annulus area (23mm: 330- 440 mm2 , 26mm: 430-550 mm2, 29mm: 540-690 mm2)\n7. Understands the study requirements and the treatment procedures and provides written informed consent\n8. Subject agrees to complete all required scheduled follow-up visits.\n\nExclusion Criteria:\n\nSubjects will be excluded for entry in this study if ANY of the following conditions are met:\n\nAnatomical\n\n1. Cardiac anatomy precluding safe placement of a transcatheter aortic valve.\n2. Iliofemoral vessel characteristics (vessel diameter \\\u003C5.5mm for smaller THV systems \\[20-26mm valve sizes\\] or \\\u003C6.0mm for larger THV systems \\[29mm or larger valve sizes\\]) that would preclude safe placement of commercially available transcatheter aortic valves (SAPIEN 3 or Evolut)\n3. Pre-existing prosthetic heart valve or ring except in the mitral position.\n4. Unicuspid aortic valve\n5. Severe aortic regurgitation (\\>3+)\n6. Severe mitral or severe tricuspid regurgitation(\\>3+) requiring intervention.\n7. Moderate to severe mitral stenosis.\n8. Hypertrophic obstructive cardiomyopathy (HOCM)\n9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment.\n10. Significant aortic disease including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5.5 cm or greater or ascending aortic aneurysm defined as maximal luminal diameter 5 cm or greater.\n\n    Clinical\n11. Evidence of an acute myocardial infarction ≤ 30 days before enrollment.\n12. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure\n13. Blood dyscrasias as defined: leukopenia (WBC \\\u003C 3000 cell\u002FmL, anemia (Hgb \\\u003C 9 g\u002FdL), thrombocytopenia (platelet count \\\u003C 50,000 cells\u002FmL), history of bleeding diathesis or coagulopathy.\n14. Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization\n15. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support within the past 30 days.\n16. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of enrollment\n17. Need for emergency surgery for any reason\n18. Ventricular dysfunction with left ventricular ejection fraction (LVEF) \\\u003C 25% as measured by resting echocardiogram\n19. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).\n20. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment\n21. Renal insufficiency (eGFR \\\u003C 30 ml\u002Fmin per the Cockcroft-Gault formula) and\u002For renal replacement therapy, or end stage renal disease requiring chronic dialysis\n22. GI bleeding within the past 3 months\n23. Severe lung disease (FEV1 \\\u003C 50% predicted) or currently on home oxygen\n24. History of cirrhosis or any active liver disease\n25. Significant abdominal or thoracic aortic disease (such as porcelain aorta, abdominal aortic aneurysm \\> 5.0 cm, severe calcification, aortic coarctation, etc.) that would preclude safe passage of the delivery system\n26. Severe pulmonary hypertension (e.g., PA systolic pressure ≥ 2\u002F3 systemic pressure)\n27. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin, heparin, ticlopidine and clopidogrel, contrast media, nickel, cobalt ,chromium, titanium, molybdenum, rhenium, polyethylene materials.\n28. Ongoing sepsis, including active endocarditis\n29. BMI \\> 50 kg\u002Fm2\n30. Subject refuses a blood transfusion\n31. Life expectancy \\\u003C 12 months due to associated non-cardiac co-morbid conditions\n32. Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent\n33. Severe dementia (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)\n34. Currently participating in an investigational drug or another investigational device trial\n35. Subject is contraindicated for cardiac CT\n36. Subject belongs to a vulnerable population (Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention).",{"count":567,"type":22},1025,[88],"To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.",[571,28],"Symptomatic Severe Native Aortic Stenosis",[28],"2026-04-03",{"date":575,"type":33},"2026-04-09",{"date":577,"type":22},"2026-04",{"date":579,"type":22},"2028-04",{"name":581,"class":110},"MiRus",{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":588,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":18,"minAge":590,"maxAge":4,"enrollmentInfo":591,"targetDuration":4,"studyType":23,"phases":593,"briefSummary":594,"conditions":595,"keywords":596,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":4},"100632598","tavi-without-on-site-cardiac-surgery-in-poland-a-randomized-multicenter-trial-protocol-100632598","NCT07515768","TAVI Without On-Site Cardiac Surgery in Poland: A Randomized Multicenter Trial Protocol","Transcatheter Aortic Valve Implantation Without On-Site Cardiac Surgery in Poland: Protocol for a Multicenter Prospective Randomized Open-label Clinical Trial","NOSCAR-TAVI","Inclusion Criteria:\n\n* Severe degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient ≥40 mmHg or jet velocity ≥4.0 m\u002Fs or an aortic valve area (AVA) of ≤1 cm2 (or AVA index \\\u003C0.6 cm2\u002Fm2)\n* Symptomatic due to aortic valve stenosis as demonstrated by NYHA Functional Class ≥ II.\n* Suitable for percutaneous transfemoral access\n* Age ≥70 years\n\nExclusion Criteria:\n\n* Prior aortic valve replacement\n* Bicuspid aortic valve on pre-procedural CT\n* Contraindication to femoral access\n* Other imaging features indicating increased procedural risk (extremely horizontal aorta, severe aortic root dilatation, aortic annulus outside the range of commercially available devices, high coronary risk occlusion)\n* Life expectancy \\\u003C12 month or active malignancy\n* Active endocarditis","70 Years",{"count":592,"type":22},404,[88],"Aortic stenosis (AS) represents the most prevalent acquired valvular heart disease in European populations, and transcatheter aortic valve implantation (TAVI) has become the dominant treatment modality for patients with symptomatic severe AS. The latest 2025 ESC guidelines have broadened age-related eligibility, while the procedure still continues to be limited to centres with cardiac surgery on-site (CSOS). This limitation is in place, despite the very low rate of complications requiring emergent surgical conversion. This subsequently, may constrain procedural capacity and contribute to prolonged waiting times, which in turn are associated with increased pre-procedural mortality and heart failure-related hospitalizations. This prospective randomized open-label clinical trial aims to evaluate the safety and feasibility of performing TAVI in selected pilot centers operating without on-site cardiac surgery department (no-CSOS). Selected patients with severe native AS deemed suitable for transfemoral TAVI by a Heart Team will be enrolled. No-CSOS centers must meet predefined criteria, including operators experience, hybrid operating room availability, on-site vascular surgery availability, and established rapid transfer pathways to CSOS centers. The primary endpoint of the study is early 30-day safety based on VARC-3 criteria; secondary endpoints include additional composite outcomes. Patients will be randomly assigned in a 1:1 ratio using a central Web-based system to undergo TAVI either at a CSOS or non-CSOS site. A total of 404 patients (202 per group) is required. The study will inform national strategies and contribute to defining contemporary safety standards for TAVI delivery in no-CSOS centres.",[28],[372,597],"transcatceter aortic valve implantation","2026-03-31",{"date":600,"type":33},"2026-04-07",{"date":602,"type":22},"2026-09-01",{"date":604,"type":22},"2030-09-01",{"name":606,"class":40},"Medical University of Warsaw",{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":613,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":18,"minAge":615,"maxAge":616,"enrollmentInfo":617,"targetDuration":152,"studyType":50,"phases":4,"briefSummary":619,"conditions":620,"keywords":621,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":342},"100632120","pressure-based-evaluation-of-disease-improvement-in-the-course-of-tavi-100632120","NCT07509554","PRessure-based Evaluation of Disease Improvement in the Course of TAVI","Investigation of the Relationship Between Changes in Modern Wave-Based Hemodynamic Metrics and Procedural Success or Clinical Improvement in Patients With Severe Aortic Stenosis Following Transcatheter Aortic Valve Replacement (TAVR)","PREDIC-TAVI","Inclusion Criteria:\n\n* Age 60-90 years.\n\nConfirmed diagnosis of severe Aortic Stenosis (AS) and a confirmed guideline-based indication for Transcatheter Aortic Valve Implantation (TAVI) by a multidisciplinary Heart Team, in accordance with the latest ESC\u002FEACTS guidelines.\n\n(In the presence of Vmax ≥ 4.0 m\u002Fs, Mean Gradient ≥ 40 mmHg, or AVA ≤ 1.0 cm²; applicable primarily to all symptomatic patients, adopting a proactive approach regarding age limits and risk profiles. Guidelines recommend TAVI as the first-line therapy \\[Class I\\] for all patients aged 70 and older with anatomical suitability and a tricuspid valve structure, regardless of surgical risk. For patients under 70, TAVI is recommended when surgical risk is high or surgery is deemed unsuitable. In asymptomatic individuals, a decline in left ventricular ejection fraction \\[LVEF\\] below 55% \\[not attributable to other causes\\] constitutes a Class I indication for intervention. Early intervention \\[Class IIa\\] is considered for patients with preserved EF but high-risk markers such as very severe stenosis \\[Vmax \\> 5.0 m\u002Fs\\], rapid progression \\[increase \\> 0.3 m\u002Fs\u002Fyear\\], significant NT-proBNP elevation \\[\\> 3 times the upper limit of normal\\], or severe pulmonary hypertension. In cases of low-flow, low-gradient \\[LFLG\\] AS, the indication for TAVI arises if true-severe stenosis is confirmed via dobutamine stress echocardiography or CT calcium scoring \\[Male ≥ 2000, Female ≥ 1200\\]. All treatment decisions are finalized by a multidisciplinary Heart Team assessing anatomy, frailty, and patient preferences.)\n\nWritten informed consent.\n\nExclusion Criteria:\n\n* Active infection, uncontrolled systemic disease, active malignancy, or life expectancy \\\u003C 1 month.\n\nPregnant or lactating patients.\n\nPressure tracings with significant artifacts hindering analysis or uncontrolled arrhythmia (e.g., atrial fibrillation with rapid ventricular response).\n\nAny other condition deemed clinically unsuitable by the investigator.","60 Years","90 Years",{"count":618,"type":22},100,"The goal of this prospective observational study is to learn if advanced heart pressure wave analysis (using methods called WIA and REPA) can help predict the success of the procedure and long-term recovery in adults (aged 60-90) with severe Aortic Stenosis who are undergoing Transcatheter Aortic Valve Replacement (TAVR\u002FTAVI).\n\nThe main questions it aims to answer are:\n\nDo changes in heart pressure wave patterns immediately after the new valve is implanted relate to improvements in a patient's quality of life and heart health over the following year?\n\nCan these advanced wave measurements better predict major heart complications (MACE) at 30 days, 180 days and 1 year compared to standard clinical tests?\n\nParticipants will:\n\nUndergo a standard TAVR (TAVI) procedure as part of their regular medical care to replace a narrowed heart valve.\n\nHave their aortic pressure waves recorded through a catheter during the routine procedure (this happens during the surgery and does not require any additional incisions or invasive steps).\n\nComplete quality-of-life surveys (EQ-5D-5L) and clinical assessments before the procedure.\n\nBe followed up via telephone calls or electronic health records at 30 days, 180 days and 12 months after the procedure to check on their recovery and overall health status.",[28],[190,189,622,623,624],"AORTIC STENOSIS","wave intensity analysis","reservoir excess pressure analysis","2026-03-29",{"date":573,"type":33},{"date":628,"type":22},"2026-03-30",{"date":630,"type":22},"2029-08",{"name":632,"class":531},"Istanbul Mehmet Akif Ersoy Educational and Training Hospital",{"id":634,"slug":635,"hasResults":12,"nctId":636,"briefTitle":637,"officialTitle":638,"acronym":639,"eligibilityCriteria":640,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":641,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":643,"conditions":644,"keywords":649,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":652,"lastUpdatePostDateStruct":653,"startDateStruct":654,"completionDateStruct":655,"leadSponsor":657,"locationsCount":342},"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":642,"type":22},500,"Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.",[645,646,647,648],"Transcatheter Aortic Valve Replacement (TAVR)","Aortic-Stenosis","Aortic Insufficiency","Degenerative Valve Disease",[189,650,651,190,28],"SAPIEN 3 Ultra RESILIA Valve","S3UR","2026-03-25",{"date":628,"type":33},{"date":167,"type":22},{"date":656,"type":22},"2037-09-30",{"name":658,"class":659},"Institut für Pharmakologie und Präventive Medizin","NETWORK"]