[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-valve-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-valve-stenosis":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,90,0,25,[9,48,83,109,137,162,191,220,241,271,298,326,355,376,402,424,443,460,483,500,520,564,596,617,634],{"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":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100490954","phase-4-enavogliflozin-outcome-trial-in-patients-with-severe-aortic-stenosis-after-transcatheter-aortic-valve-replacement-100490954",false,"NCT05672836","ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement","A Randomized, Double-Blind, Placebo-controlled Trial to Evaluate Efficacy and Safety of a Novel Sodium-Glucose Cotransporter 2 Inhibitor, Enavogliflozin Compared to Placebo on Reducing Major Cardiovascular Events or Worsening Heart Failure in Patients With Severe Aortic Stenosis Who Underwent Transcatheter Aortic Valve Replacement (TAVR) and With Heart Failure With Preserved Ejection Fraction (HFpEF)","ENAVO-TAVR","Inclusion Criteria:\n\n1\\. Patients aged ≥19 with symptomatic aortic stenosis who underwent successful transcatheter aortic valve replacement (TAVR)\\* (either native valve or valve in valve with any approved\u002Fmarketed device).\n\n\\* A successful TAVI is defined as device success according to the VARC-2(Valve Academic Research Consortium 2) and VARC-3 criteria:\n\n1. correct positioning of a single prosthetic heart valve into the proper anatomical location AND\n2. intended performance of the prosthetic heart valve (mean aortic valve gradient \\\u003C20 mmHg, peak velocity \\\u003C3 m\u002Fs, no moderate or severe prosthetic valve regurgitation) AND\n3. absence of periprocedural complications (any type of stroke, life-threatening bleeding, acute coronary artery obstruction requiring intervention, major vascular complication requiring intervention, unresolved acute valve thrombosis, or any requirement of a repeat procedure).\n\n2\\. Heart Failure with Mildly Reduced or Preserved Ejection Fraction\n\n1. Left ventricular ejection fraction (LVEF) ≥40%\n2. structural heart disease\\_Left ventricular hypertrophy (LVH) or Left atrial enlargement\n\n   A. Left ventricular hypertrophy (LVH) with septal thickness or posterior wall thickness ≥ 1.1 cm or\n\n   B. Left atrial (LA) enlargement with at least one of the following: LA width (diameter) ≥3.8 cm or LA length ≥ 5.0 cm, or LA area ≥ 20cm2, or LA volume ≥ 55mL or LA volume index ≥ 29mL\u002Fm.\n3. NT-proBNP ≥ 300 pg\u002FmL (for patients without ongoing atrial fibrillation) or NT-proBNP must be ≥ 600 pg\u002FmL (for patients with ongoing atrial fibrillation).\n\n3\\. Patients who voluntarily participated in the written agreement\n\nExclusion Criteria:\n\n1. Acute decompensated Heart Failure (exacerbation of chronic Heart Failure) requiring intravenous diuretics, vasodilators, inotropic agents, or mechanical support, or hemodynamic instability following the transcatheter aortic valve replacement procedure.\n2. Currently receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomization; discontinuation of current use of SGLT2 inhibitor for the purposes of study enrolment is not permitted.\n3. Known allergy, hypersensitivity, or previous intolerance to an SGLT2 inhibitors.\n4. HF with reduced ejection fraction (LVEF \\\u003C40%).\n5. Type 1 diabetes mellitus or diabetes ketoacidosis.\n6. Chronic cystitis and\u002For recurrent urinary tract infection (≥2 times within 1 year).\n7. Stroke or transient ischemic attack within 12 weeks prior to enrollment.\n8. Symptomatic persistent hypotension and\u002For a systolic blood pressure (SBP) \\\u003C 95 mm Hg at screening or at randomization.\n9. SBP ≥180 mmHg irrespective of treatment or SBP ≥160 mmHg with at least ≥3 antihypertensive drugs at screening or randomization.\n10. Heart failure due to any of the following causes; known infiltrative cardiomyopathy (e.g. amyloid, sarcoid, lymphoma, endomyocardial fibrosis, haemochromatosis, Fabry disease), active myocarditis, constrictive pericarditis, cardiac tamponade, known hypertrophic obstructive cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy\u002Fdysplasia (ARVD), or uncorrected primary valvular disease.\n11. Severe renal insufficiency (eGFR \\\u003C30 ml\u002Fmin\u002F1.73 m2 of body-surface area based on the Modification of Diet in Renal Disease (MDRD) formula) or end-stage renal disease or requiring dialysis at the time of screening.\n12. Acute or chronic liver disease with severe impairment of liver function (e.g., ascites, esophageal varices, coagulopathy) or serum levels of transminases or alkaline phosphatase more than two times the upper limit of normal at screening.\n13. Chronic pulmonary disease requiring home oxygen, oral steroid therapy or hospitalization for exacerbation within 12 months, or significant chronic pulmonary disease in the Investigator's opinion, or primary pulmonary arterial hypertension.\n14. Current or suspicious malignancy or history of malignancy within 5 years\n15. Uncontrolled anaemia or haemoglobin \\\u003C9g\u002Fdl\n16. Uncontrolled hypothyroidism or arrhythmia or tachycardia\n17. Current ongoing alcoholic or drug addict\n18. Subjects with non-cardiac co-morbidities with life expectancy less than 12 months\n19. Planned major high-risk operation after transcatheter aortic valve replacement (TAVR)\n20. Women of childbearing age who have not reached a consensus on the use of highly effective contraception. Pregnancy or breastfeeding.\n21. Participation in other clinical trials, However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion;\n\n    * Participating in the observational study expected no effect on the safety and\u002For effectiveness evaluation of this trial.\n    * Screening failed before any interventional factor is involved.\n    * Participants who have completed their involvement in clinical trials and have surpassed a 4-week period since their last administration of the investigational drug.\n    * Participated in academic trials like strategic or medical device comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference between this trial and other studies.","ALL","19 Years",{"count":21,"type":22},1040,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","The goal of this trial is to to determine whether use of a novel SGLT2 inhibitor, Enavogliflozin 0.3 mg once daily is superior to placebo, when added to standard-of-care, in reducing the composite of major cardiovascular events and Heart Failure events (hospitalization for Heart Failure or urgent Heart Failure visit) among patients who underwent transcatheter aortic valve replacement for severe aortic stenosis and with heart failure with preserved ejection fraction.",[28,29],"Aortic Valve Stenosis","Heart Failure",[31,32,33,34],"Transcatheter Aortic Valve Implantation","heart failure with preserved ejection fraction","Sodium-glucose cotransporter-2 inhibitor","transcatheter aortic valve replacement","RECRUITING","2026-06-26",{"date":38,"type":39},"2026-06-29","ACTUAL",{"date":41,"type":39},"2024-12-18",{"date":43,"type":22},"2029-04",{"name":45,"class":46},"Duk-Woo Park, MD","OTHER",31,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"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":57,"type":22},663,[59],"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.",[28,62,63],"Aortic Stenosis","Aortic Valve Disease",[65,66,67,68,69,70,71,72],"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":36,"type":39},{"date":76,"type":39},"2026-05-12",{"date":78,"type":22},"2028-05",{"name":80,"class":81},"EmStop Inc","INDUSTRY",3,{"id":84,"slug":85,"hasResults":12,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":12,"sex":18,"minAge":91,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100558951","redo-transcatheter-aortic-valve-implantation-for-the-management-of-transcatheter-aortic-valve-failure-100558951","NCT06557798","REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure","Prospective, Multi-centre Clinical Investigation Evaluating the Outcomes of Patients Treated by Redo Transcatheter Aortic Valve Implantation for Bioprosthetic Valve Failure of a Transcatheter Aortic Valve","REVALVE","Inclusion Criteria:\n\n1\\. Bio-prosthetic Valve Failure (BVF) of a Transcatheter Aortic Valve requiring possible reintervention\n\nExclusion Criteria:\n\n1. Bio-prosthetic Valve Failure due solely to paravalvular aortic regurgitation\n2. Active endocarditis\n3. Untreated acute valve thrombosis\n4. Life-expectancy less than 1 year\n5. Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable\n6. Pregnant or nursing","18 Years",{"count":93,"type":22},550,"OBSERVATIONAL","Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and\u002For leaking. Although TAVI is a safe and effective treatment for a faulty aortic heart valve, the new TAVI valve will not last forever. Because it is a 'tissue' valve (made from the lining of a cow or pig heart), the valve will fail after a period of time as the tissue degenerates.\n\nWhen the TAVI valve fails, a viable treatment option is to perform a 'Redo TAVI' procedure, implanting a second TAVI valve inside the first failing valve.\n\nThe main purpose of this study is to carefully evaluate patients being treated by Redo TAVI in order to document the short-term and long-term outcomes of the procedure. The study will also obtain information about which factors predict those outcomes.\n\nThe study will also assess outcomes in patients who present with TAVI valve failure but are not suitable for Redo TAVI, and instead are treated either by open-heart surgery and surgical aortic valve replacement, or by medical therapy (medication).\n\nThe study will provide doctors the information they need to understand the best way to treat patients who present with TAVI valve failure, and in particular how to perform Redo TAVI procedures with the best possible outcomes for patients.",[28],[98],"Bioprosthetic Valve Failure","2026-06-22",{"date":101,"type":39},"2026-06-25",{"date":103,"type":39},"2024-12-12",{"date":105,"type":22},"2033-03",{"name":107,"class":46},"The Leeds Teaching Hospitals NHS Trust",71,{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":18,"minAge":91,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"100519907","comparison-of-allegra-vs-sapien-transcatheter-aortic-valves-in-valve-in-valve-indication-100519907","NCT06049654","Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication","Clinical Trial of the Results of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication","Inclusion Criteria:\n\nPatients meeting ALL the following criteria will be included:\n\n* Patients aged ≥ 18 years.\n* Severe haemodynamical valve deterioration of a biological aortic valve implanted surgically, including severe valve stenosis (effective aortic valve area \\\u003C 1.0 cm2) and\u002For severe valve regurgitation.\n* The patient has cardiac symptoms and\u002For deterioration of left ventricular ejection fraction attributable to the aortic valve disease.\n* Heart team decision of VIV procedure.\n* Patient is willing to return at 30 days for TTE and to be clinically contacted at 1 year.\n\nExclusion Criteria:\n\nPatients meeting, at least, 1 of the following criteria will be excluded:\n\n* Patients who openly express their refusal to participate in the study.\n* Female patients in gestational age.\n* Presence or suspicious of biological aortic valve thrombosis.\n* Known hypersensitivity or contraindication to antithrombotic therapy (or inability to be anticoagulated during the procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated.\n* Ongoing sepsis and\u002For suspicious or diagnosis of endocarditis.\n* Patients whose life expectancy is \\\u003C 1 year due to non-cardiac comorbid conditions.\n* Medical, social, or psychological conditions that preclude the subject from appropriate consent or adherence to the protocol required follow-up exams.\n* True inner diameter of the prosthetic valve \\> 27 mm.\n* Transfemoral access inadequate to accommodate an 18F sheath.\n* Patients included in other clinical trials (excluding registries).",{"count":117,"type":22},104,[59],"The VIVALL-2 study is a randomized trial to compare the self-expandable supra-annular Allegra and the balloon-expandable intra-annular Edwards transcatheter valve systems in patients with degenerated biological aortic surgical valve.",[28,121],"Structural Valve Deterioration",[123,72,124,125,126],"Valve-In-Valve","Aortic regurgitation","Trans-catheter aortic valve","Degenerated aortic valve","2026-06-12",{"date":129,"type":39},"2026-06-15",{"date":131,"type":39},"2024-02-01",{"date":133,"type":22},"2027-11-01",{"name":135,"class":46},"Fundación EPIC",11,{"id":138,"slug":139,"hasResults":12,"nctId":140,"briefTitle":141,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":18,"minAge":91,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":146,"briefSummary":148,"conditions":149,"keywords":150,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":161},"100462992","phase-2-impact-of-local-tissue-inflammation-on-intramyocardial-conduction-pathways-post-percutaneous-valve--evaluation-by-positron-emission-tomography-on-exploratory-cohort-100462992","NCT05308888","Impact of Local Tissue Inflammation on Intramyocardial Conduction Pathways Post Percutaneous Valve : Evaluation by Positron Emission Tomography on Exploratory Cohort","IMPACT","Inclusion Criteria:\n\n* Major patient (\\>18 years of age);\n* Patient with aortic stenosis defined by aortic valve area ≤ 1cm2 (or indexed aortic valve area ≤ 0.6 cm2\u002Fm2 body surface area), OR transvalvular peak velocity ≥ 4 m\u002Fs OR transvalvular mean gradient ≥ 40 mmHg, as assessed by transthoracic echocardiography performed in a patient at rest;\n* Symptomatic patient with: dyspnea ≥ New-York Heart Association (NYHA) stage 2 OR pathological stress test with onset of symptoms on exertion, blood pressure drop, or rhythm disorder on exertion OR Asymptomatic with Left Ventricular Ejection Fraction \\\u003C 50% ;\n* Patient with vascular anatomy compatible with percutaneous femoral valve implantation;\n* Patient affiliated to or benefiting from a health insurance plan;\n* Patient who has provided free, informed and written consent.\n\nExclusion Criteria:\n\n* Patient with a pacemaker or triple chamber defibrillator prior to TAVI implantation;\n* Patient with a uni or bicuspid aortic valve;\n* Patient with severe left ventricular dysfunction LVEF \\\u003C 30%;\n* Patient with other significant valve disease : aortic insufficiency ≥ grade 3, mitral insufficiency ≥ grade 3 or tight mitral stenosis ;\n* Patient with iliofemoral vascular anatomy preventing safe passage of the valve;\n* Patient with a pre-existing bioprosthesis or mechanical prosthesis at TAVI in any position;\n* Inability or refusal to consent;\n* Pregnant or breastfeeding woman;\n* Patient under judicial protection or family habilitation;\n* Patient deprived of liberty by judicial or administrative decision, under guardianship or curatorship;\n* Patient with life expectancy \\\u003C 12 months.",{"count":145,"type":22},100,[147],"PHASE2","Aortic valve stenosis is the most common valve disease leading to surgical or percutaneous intervention in Europe and North America. Percutaneous aortic valve replacement (TAVI) is currently recommended for the management of patients with symptomatic aortic stenosis and with high; very high operative risk of aortic valve replacement surgery or intermediate operative risk of aortic valve replacement surgery after a benefit-risk assessment by a heart team and operative contraindication to conventional aortic valve replacement surgery. These indications are supported by the 2017 European Cardiology guidelines.\n\nThis technique of percutaneous arterial valve implantation is most often performed via the femoral route, under local anesthesia, with placement of a prosthetic biological valve in the aortic position, impacting it into the patient's native aortic valve.\n\nTAVI has been shown to be superior to medical treatment in patients with a aortic valve stenosis at very high operative risk of conventional aortic valve replacement surgery. However, the occurrence of atrioventricular conduction disorders (de novo left bundle branch block (LBBB) or complete AVB) remains the most frequent complication after TAVI. Therefore, the rate of pacemaker (PM) implantation after TAVI remains high, ranging from 2% to 51%, with an average rate of 13%.\n\nPacemaker implantation has several deleterious effects (increased hospitalization time, desynchronization of the left ventricle by permanent right ventricular pacing, exposure of the patient to procedural complications of pacemaker placement, and possible increase in the final cost to society of the initial hospitalization.\n\nNot all patients who received a pacemaker post TAVI implantation use their PM. The rate of Pacemaker dependency and therefore of patients who actually use their pacemaker is approximately 33-36% at 1 year after percutaneous valve implantation.\n\nIn view of all the potentially deleterious consequences of post TAVI pacemaker implantation, it is therefore necessary to know which patients really justify pacemaker implantation after percutaneous valve implantation.\n\nThe purpose of this study is to investigate diagnostic imaging criteria that may be predictive of the occurrence of intramyocardial conduction disorders post TAVI implantation. Although some patients present only transient conductive disturbances, the impact of tissue inflammation of the intramyocardial conduction pathways after TAVI remains to be understood.",[28],[151],"TAVI","2026-06-08",{"date":154,"type":39},"2026-06-09",{"date":156,"type":39},"2022-11-23",{"date":158,"type":22},"2028-11-23",{"name":160,"class":46},"University Hospital, Brest",1,{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":18,"minAge":91,"maxAge":4,"enrollmentInfo":170,"targetDuration":172,"studyType":94,"phases":4,"briefSummary":173,"conditions":174,"keywords":177,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":161},"100637453","impact-of-trans-catheter-aortic-valve-implantation-on-renal-function-100637453","NCT07626710","Impact of Trans-catheter Aortic Valve Implantation on Renal Function","Impact of Trans-catheter Aortic Valve Implantation on Kidney Response to Contrast Dye Administration: an Observational Registry","TAVIKOD","Inclusion Criteria:\n\n* Age \\>18 years with a life expectancy \\>1 year;\n* Patient candidate for percutaneous aortic valve implantation after formal indication of our \"Heart Team\".\n* Patient performed at least one contrast-based exam other than the TAVI procedure in the previous two months.\n* Patients had adequate renal function assessment after each contrast medium administration (TAVI procedure included) with at least three post-procedural measurements in the following 5 days.\n* Patients were informed of the possibility to be the object of anonymized data collection for study protocols approved by the internal Ethical Committee and had provided written informed consent to the procedure (for patients before 2018) or had provided written informed consent to the research purposes of IRCCS (for patients from 2018 to date).\n\nExclusion Criteria:\n\n* Female with childbearing potential or lactating;\n* Acute or chronic end-stage renal dysfunction defined as estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m2);\n* Candidate for dialysis treatment;\n* Co-morbidities that could interfere with the completion of study procedures, or life expectancy of less than 1 year;\n* Absent or incomplete renal function assessment after each contrast-based procedure;\n* Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;",{"count":171,"type":22},1000,"5 Years","Both contrast-induced acute kidney injury (AKI) and pre-existing chronic kidney disease are associated with an increased mortality risk in patients requiring aortic valve replacement. Nonetheless, the direct haemodynamic impact of the aortic barrage (i.e. pre-renal mechanism) on renal function compromising and its reversibility in patients undergoing trans-catheter aortic valve implantation (TAVI) is unknown.\n\nThis registry aims to evaluate the effect of severe aortic stenosis removal on the risk of contrast-induced acute renal injury (CI-AKI) during TAVI procedures and on renal function evolution",[28,175,176],"Chronic Kidney Diseases","Renal Failure Acute Chronic",[178,179,180,181],"Trans-catheter aortic valve implantation","Contrast-induced acute renal injury","Kidney failure","Observational registry","2026-05-31",{"date":184,"type":39},"2026-06-04",{"date":186,"type":39},"2024-08-30",{"date":188,"type":22},"2033-08-30",{"name":190,"class":46},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":18,"minAge":91,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":200,"conditions":201,"keywords":205,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":4},"100639710","prospective-neuropsychological-evaluation-of-the-implementation-of-a-heart-valve-unit-hvu-neuro-100639710","NCT07626567","Prospective Neuropsychological Evaluation of the Implementation of a Heart Valve Unit (HVU-NEURO)","HVU-NEURO","Inclusion Criteria:\n\n* Severe aortic valve stenosis\n* Indication for transcatheter valve therapy according to current guideline recommendations and\u002For Heart-Team consensus\n* Sufficient German language proficiency, as study-related tests, questionnaires, and instructions are administered in German\n* Age ≥18 years\n* Willingness to participate voluntarily with written informed consent\n\nExclusion Criteria:\n\n* Known pregnancy at the time of study inclusion\n* Life expectancy \\\u003C1 year due to non-cardiac disease\n* Pre-interventional psychiatric and neurological disorders (known and diagnosed dementia, depression, history of stroke or transient ischemic attack \\[TIA\\], migraine, epilepsy) with acute symptoms that may interfere with data collection",{"count":199,"type":22},500,"Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis. Despite improved procedural outcomes, neurocognitive complications such as postoperative delirium (POD) and postoperative cognitive decline (POCD) remain clinically relevant.\n\nHeart Valve Units (HVU) are specialized interdisciplinary care structures designed to improve treatment pathways and healthcare quality. However, their impact on neuropsychological outcomes has not been sufficiently investigated.\n\nHVU-NEURO is a prospective observational cohort study evaluating neuropsychological outcomes before and after implementation of an HVU. Approximately 500 patients undergoing transcatheter valve therapy will be included.\n\nNeurocognitive function will be assessed before intervention, at hospital discharge, and three months after intervention. POD will be assessed using the Intensive Care Delirium Screening Checklist (ICDSC). The primary objective is to evaluate the effect of HVU implementation on postoperative cognitive decline at discharge from acute hospital care.",[28,202,203,204],"Postoperative Cognitive Dysfunction (POCD)","Delirium - Postoperative","Neurocognitive Disorders",[151,206,207,208,209,31,210],"HVU","Postoperative Cognitive Decline","Postoperative Delirium","Neuropsychology","Intensive Care Delirium Screening Checklist","NOT_YET_RECRUITING","2026-05-29",{"date":184,"type":39},{"date":215,"type":22},"2026-05-25",{"date":217,"type":22},"2028-02",{"name":219,"class":46},"Heart and Brain Research Group, Germany",{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":227,"sex":18,"minAge":91,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":161},"100614819","smartphone-based-digital-screening-for-aortic-valve-stenosis-100614819","NCT07284550","Smartphone Based Digital Screening for Aortic Valve Stenosis","SMART-VALVE","The following inclusion and exclusion criteria will be used for training, validation and test sets:\n\nInclusion criteria for group I (moderate to severe AS):\n\n* Moderate to severe AS defined as AVA ≤ 1.5cm² in echocardiographic assessment\n* No other significant VHD, valvular prosthesis, pacemaker or congenital heart defect\n* Documented echocardiography as part of routine clinical practice no older than 90 days\n* Patient age ≥ 18 years\n* Provided written informed consent\n\nInclusion criteria for group II:\n\n* No significant VHD, valvular prosthesis, pacemaker or congenital heart defect\n* Documented echocardiography as part of routine clinical practice no older than 90 days\n* Patient age ≥ 18 years\n* Provided written informed consent\n\nExclusion criteria (applicable for all groups):\n\n• Informed consent form not signed.",true,{"count":199,"type":22},"Heart valve diseases are among the most serious cardiovascular conditions in older age. One of the most common forms is aortic valve stenosis, a narrowing of the valve opening between the left ventricle and the main artery. As the valve becomes tighter, the heart must work harder and harder to pump blood through the body. This process often develops slowly over many years and initially causes no clear symptoms. As a result, the condition is frequently detected only in advanced stages, when warning signs such as shortness of breath, chest pain, or dizziness appear. Without treatment, aortic valve stenosis can become life-threatening. If detected early, however, very effective treatment options are available today.\n\nUp to now, the disease has been reliably diagnosed mainly through echocardiography. Yet this method is complex, costly, and requires specialized medical staff. A simple, affordable, and broadly accessible screening option does not yet exist.\n\nThe interdisciplinary clinical research project explores whether conventional smartphones could fill this gap. Almost all modern devices are equipped with sensors such as microphones, accelerometers, and gyroscopes. These can capture both heart sounds and subtle vibrations of the chest. The research team is investigating whether reliable diagnostic information for the diagnosis of aortic valve stenosis can be extracted from such recordings. To achieve this, the signals are processed with newly developed methods and analyzed using artificial intelligence.\n\nFor the study, several hundred patients with and without valve disease will be examined. The smartphone results will be compared with established diagnostic standards, particularly echocardiography, to test accuracy and reliability.\n\nIf successful, the approach could enable a straightforward, digital heart check at home using nothing more than a conventional smartphone. Such a tool would provide an accessible, low-cost, and widely available method for early detection, helping more people receive timely and potentially life-saving treatment.",[28,231],"Artifical Intelligence","2026-05-27",{"date":234,"type":39},"2026-05-28",{"date":236,"type":39},"2026-01-12",{"date":238,"type":22},"2029-11",{"name":240,"class":46},"Medical University Innsbruck",{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":18,"minAge":91,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":23,"phases":251,"briefSummary":252,"conditions":253,"keywords":255,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":270},"100341627","von-willebrand-factor-point-of-care-testing-to-improve-minimally-invasive-tavi-outcomes-100341627","NCT03728049","Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes","Point-of-care Haemostasis Testing of Von Willebrand Factor Function Embedded in Catheterization Laboratory to Improve Real-time Management of Paravalvular Regurgitation During Minimally Invasive TAVI","WITAVI-REAL","Inclusion Criteria:\n\n* All patients scheduled to undergo mini-invasive TAVI at any of the participating centers and fulfilling the inclusion criteria will be eligible for entry in the study. The decision to undertake TAVI will be made by the local heart team.\n* Symptomatic aortic stenosis scheduled to undergo TAVI\n* TAVI performed via mini-invasive approach defined as: transfemoral access route; local anesthesia\u002Fconscious sedation; no TEE guidance.\n* All types of prosthetic valves (balloon-expandable, self-expandable, others) are accepted\n\nExclusion Criteria:\n\n* TAVI through non-transfemoral approach\n* TAVI with concomitant percutaneous coronary intervention\n* TAVI performed under general anesthesia\n* TAVI performed under TEE guidance\n* Valve-in-valve procedure\n* Inability to provide informed consent\n* Associated ≥ moderate mitral regurgitation\n* Peri-procedural treatment with ticagrelor or prasugrel treatment \u002F direct oral anticoagulant",{"count":250,"type":22},944,[59],"Paravalvular regurgitation (PVR) is an important complication of Transcatheter Aortic Valve Implantation (TAVI) that is associated with a 2.5-fold increase risk of mortality. Transesophageal echocardiographic (TEE) is considered as the gold standard to assess the severity of PVR and guide the physician to perform corrective procedures during TAVI, but it requires general anesthesia (GA). With such approach (TEE+GA), the PARTNERII trial has demonstrated that very low rate of PVR (3,5%) can be achieved with current devices. Registries have demonstrated a strong trend for using a mini-invasive approach in which the procedure is performed under conscious sedation (CS) without TEE. However, several studies raised concerns on the safety of this mini-invasive approach concerning the PVR rate. Thus, the accurate and real-time assessment of the presence and severity of PVR is an unmet clinical need to optimize TAVI without TEE guidance. A recent study reported that a blood biomarker reflecting the Von Willebrand factor (VWF) activity, i.e. the closure time with adenosine diphosphate (CT-ADP), is a valuable non-invasive, highly reproducible, and easy to perform alternative to TEE for PVR evaluation.\n\nThe hypothesis is that the measurement of CT-ADP during TAVI performed without TEE guidance can improve both the detection of significant PVR and thus the procedural and clinical outcomes (primary objective).",[28,254],"Aortic Valve Insufficiency",[256,257,258,259,72,260],"Transcatheter Aortic Valve Replacement","Paravalvular regurgitation","Point-of-care test","Biomarker","Von willebrand Factor","2026-05-20",{"date":263,"type":39},"2026-05-22",{"date":265,"type":39},"2019-12-18",{"date":267,"type":22},"2026-12",{"name":269,"class":46},"University Hospital, Lille",9,{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":18,"minAge":91,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":280,"conditions":281,"keywords":282,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":297},"100497547","the-effect-of-subclinical-leaflet-thrombosis-and-prosthesis-type-on-transcatheter-aortic-valve-degeneration-popular-pet-tavi-100497547","NCT05758662","The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration (POPular PET TAVI)","The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration","Inclusion Criteria:\n\n* Successful TAVI with Sapien or CoreValve Evolut prosthesis about 5 years ago\n* Able to undergo hybrid 18F-NaF PET-CT imaging and transthoracic echocardiography\n* Written informed consent\n\nExclusion Criteria:\n\n* Temporary or chronic oral anticoagulation use after TAVI\n* Known severe renal insufficiency\n* Known severe paravalvular regurgitation\n* History of valve-in-valve procedure\n* History of aortic valve re-intervention (including percutaneous paravalvular leak closure)",{"count":279,"type":22},180,"A multicentre cross-sectional cohort study to assess the difference in bioprosthetic micro-calcification activity, detected with 18F-NaF PET-CT, as early marker of transcatheter valve degeneration, between patients with vs. without subclinical leaflet thrombosis at five years after TAVI; and between patients with intra-annular vs. supra-annular TAVI prostheses.",[28],[151,283,284,285,286,287],"TAVR","Subclinical Leaflet Thrombosis","Bioprosthetic Valve Deterioration","Intra-annular","Supra-annular","2026-05-18",{"date":290,"type":39},"2026-05-19",{"date":292,"type":39},"2023-11-16",{"date":294,"type":22},"2026-10-01",{"name":296,"class":46},"St. Antonius Hospital",4,{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":18,"minAge":306,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":23,"phases":309,"briefSummary":310,"conditions":311,"keywords":312,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":161},"100629617","post-dilatation-in-balloon-expandable-tavi-prostheses-100629617","NCT07477002","Post-Dilatation in Balloon-Expandable TAVI Prostheses","Effects of Post-Dilatation on THV Expansion, Hemodynamics, Durability, and Outcomes in Balloon-Expandable TAVI Prostheses","DUOTAP","Inclusion Criteria:\n\n* Severe AS\n* AS treatment by transfemoral TAVI as determined by an interdisciplinary heart team board\n* Anatomical feasibility to receive a balloon-expandable THV\n* Age 65 years or older\n* Informed consent\n\nExclusion Criteria:\n\n* Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., non compliant, perforated)\n* Bicuspid aortic valve anatomy\n* Valve-in-valve procedure\n* Severe calcification of the aortic annulus protruding into the left ventricular outflow tract and predisposing for annular rupture\n* Significant stenosis of the left main or proximal left anterior descending artery with substantial risk of hemodynamic instability during rapid ventricular pacing","65 Years",{"count":308,"type":22},146,[59],"Asymmetrical and inadequate expansion of transcatheter heart valves (THVs) have been described as a key predictor of impaired valve hemodynamic performance predisposing patients for bioprosthetic valve dysfunction (BVD) and death. Post-dilatation using the original delivery system balloon at the identical filling volume after deployment of balloon-expandable THVs represents an invasive strategy to potentially optimize expansion and reduce asymmetry of balloon-expandable THVs. Currently, the efficacy and safety of routine post-dilatation has never been assessed in a randomized controlled fashion. The present randomized controlled DUOTAP trial aims to assess efficacy and safety of routine post-dilatation on THV expansion, hemodynamics, durability, and associated clinical outcomes in patients with severe aortic stenosis.",[28],[313,314,315,316,317],"Balloon-expandable TAVI prostheses","Fluoroscopic imaging","Computed tomography","Post-Dilatation","Double-Tap","2026-05-07",{"date":76,"type":39},{"date":321,"type":39},"2025-01-01",{"date":323,"type":22},"2031-05",{"name":325,"class":46},"Medical University of Vienna",{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":18,"minAge":334,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":23,"phases":337,"briefSummary":338,"conditions":339,"keywords":341,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":161},"100493901","structured-shared-decision-making-for-patients-undergoing-savr-or-tavr-100493901","NCT05711186","Structured Shared Decision Making for Patients Undergoing SAVR or TAVR","Structured Shared Decision Making for Patients Undergoing Elective Surgical or Transcatheter Aortic Valve Replacement (TOGETHER): A Randomized-controlled Trial","TOGETHER","Inclusion Criteria:\n\n1. Age ≥ 70 years\n2. Symptomatic severe aortic stenosis defined by an aortic valve area ≤1.0 cm2 or an aortic valve area indexed to body surface area \\\u003C0.6cm2\u002Fm2\n3. Both SAVR and transfemoral TAVR as reasonable treatment options based on heart team decision\n\nExclusion Criteria:\n\n1. Life expectancy \\\u003C1 year irrespective of valvular heart disease\n2. Inability to provide informed consent\n3. Participation in another clinical trial with an active intervention","70 Years",{"count":336,"type":22},140,[59],"Transcatheter aortic valve replacement (TAVR) is a well-established alternative to surgical aortic valve replacement (SAVR) for the treatment of patients with severe aortic stenosis regardless of surgical risk. While TAVR and SAVR share some of the benefits and risks, they importantly differ with regards to invasiveness, time to recovery, hemodynamics, as well as options for re-intervention and possibly valve durability. An early benefit of TAVR may be offset by late risks. Therefore, current guidelines of the European Society of Cardiology recommend an integration of patient values and preferences for the selection of the treatment modality.\n\nThe objective of the TOGETHER trial is to investigate the efficacy of a structured shared decision making approach (SDM) to improve patient-centered outcomes for the choice between SAVR and TAVR.\n\nTOGETHER is an investigator-initiated, randomized, open-label, single-center clinical trial. A total of 140 patients referred for treatment of symptomatic severe aortic stenosis and deemed to undergo TAVR or SAVR according to heart team decision will be randomized in a 1:1 ratio to structured SDM or usual care.",[28,340],"Symptomatic Aortic Stenosis",[340,28,342,343,344,345,346],"SAVR (Surgical Aortic Valve Replacement)","Shared Decision-Making","TAVR (Transcatheter Aortic Valve Replacement)","TAVI (Transcatheter Aortic Valve Implantation)","Decision Support Techniques",{"date":348,"type":39},"2026-05-08",{"date":350,"type":39},"2023-04-17",{"date":352,"type":22},"2027-12-31",{"name":354,"class":46},"Insel Gruppe AG, University Hospital Bern",{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":18,"minAge":91,"maxAge":4,"enrollmentInfo":362,"targetDuration":363,"studyType":94,"phases":4,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":4},"100636510","spanish-prospective-registry-of-hydra-thv-for-transcatheter-aortic-valve-implantation-100636510","NCT07566624","Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation","HYSPANIA","Inclusion Criteria:\n\nParticipants who meet ALL of the following conditions will be included:\n\n* Age ≥ 18 years and;\n* Severe aortic stenosis with indication for aortic valve replacement in which a Hydra THV device is implanted according to the instructions for use; and\n* Signed informed consent.\n\nExclusion Criteria:\n\nPatients who do NOT meet ANY of the following conditions will be included:\n\n* Express refusal by the participant to participate in the study.\n* Aortic stenosis patients who are not candidates for Hydra THV device implantation or in whom implantation of this device is performed for an indication other than aortic stenosis (especially pure native aortic valve insufficiency). Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses may be included in the study.\n* Participants in randomised clinical trials who have not reached the research endpoint.\n* Pregnant and\u002For breastfeeding women.",{"count":145,"type":22},"12 Months","This study is designed to evaluate the success rate of transfemoral implantation of the Hydra THV biological aortic valve prosthesis in patients with severe symptomatic aortic stenosis. The device is used in accordance with its Instructions for Use as a CE-marked transcatheter heart valve system.\n\nThe study will assess procedural success, device performance, and early clinical outcomes following implantation. Patients undergoing transcatheter aortic valve replacement (TAVR) via the transfemoral approach will be followed to evaluate safety and effectiveness outcomes, including short- and mid-term clinical follow-up.",[366,367,28],"Severe Aortic Valve Stenosis","Valvular Heart Disease","2026-04-27",{"date":370,"type":39},"2026-05-05",{"date":372,"type":22},"2026-06-01",{"date":374,"type":22},"2029-02-01",{"name":135,"class":46},{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":18,"minAge":91,"maxAge":382,"enrollmentInfo":383,"targetDuration":4,"studyType":23,"phases":385,"briefSummary":386,"conditions":387,"keywords":389,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":161},"100635733","phase-4-patient-quality-of-recovery-after-tavr-with-different-sedation-regimens-100635733","NCT07556523","Patient Quality of Recovery After TAVR With Different Sedation Regimens","Inclusion Criteria:\n\n* 18-90 years old, inclusive\n* Undergoing transfemoral TAVR under Monitored Anesthesia Care (MAC)\n* Speaks English or Spanish\n* Consents to participate\n\nExclusion Criteria:\n\n* Preoperative heart rate \\\u003C 50 bpm or arrhythmias (e.g., AFib with RVR)\n* Conduction abnormalities (e.g., 2nd\u002F3rd degree AV block without pacer)\n* Allergy or contraindication to study drugs\n* Pulmonary artery pressure \\> 70mmHg\n* Morbid obesity BMI \\> 50\n* Pregnancy\n* Unable to consent in English or Spanish","90 Years",{"count":384,"type":22},126,[25],"The goal of this clinical trial is to learn whether the type of sedation medication used during a transcatheter aortic valve replacement (TAVR) affects how people recover after the procedure. The main question this study aims to answer is whether different sedation regimens (propofol, dexmedetomidine, or midazolam with fentanyl) lead to differences in quality of recovery on the first day after the procedure.\n\nResearchers will compare three commonly used sedation medications (propofol, dexmedetomidine, or midazolam with fentanyl) to determine whether they lead to differences in recovery following a TAVR.\n\nParticipants will:\n\n* Be enrolled before their scheduled TAVR procedure\n* Be randomly assigned to receive one of the three sedation medications during their procedure\n* Complete short surveys on postoperative days 1 and 7 about pain levels, how they feel during their recovery, and how satisfied they were with their anesthesia experience",[388,28],"Transcatheter Aortic Valve Replacement (TAVR)",[390,283,391,392],"Transcatheter aortic valve replacement","Sedation strategy","Anesthesia","2026-04-22",{"date":395,"type":39},"2026-04-29",{"date":397,"type":39},"2026-03-16",{"date":399,"type":22},"2028-06",{"name":401,"class":46},"David Lyubashevsky",{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":18,"minAge":91,"maxAge":409,"enrollmentInfo":410,"targetDuration":412,"studyType":94,"phases":4,"briefSummary":413,"conditions":414,"keywords":415,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":297},"100555091","hydra-registry---uk-100555091","NCT06507579","Hydra Registry - UK","Prospective Observational Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve","Inclusion Criteria:\n\n1. Patients with severe aortic stenosis eligible for transfemoral TAVI procedure as per local Heart Team evaluation\n2. Full understanding and willing to provide informed consent to study enrolment\n3. Age ≥ 18 years\n\nExclusion Criteria:\n\n1. Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)\n2. Refusal to provide informed consent to study enrolment\n3. Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI\n4. Patients with significant calcification of the aortic annulus and in the Left Ventricular Outflow Tract (LVOT), or\u002Fand excess calcium within each cusp, or those who are deemed unsuitable for the Hydra THV series based on the clinical judgment of the Investigator.","99 Years",{"count":411,"type":22},250,"1 Year","The study will evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) using the Hydra transcatheter aortic heart valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. This will include an evaluation of the preservation of coronary access post implant by attempting to selectively engage both the right and left coronary arteries through standardised angiographic views.\n\nThe study will also examine the utility of 72 hours of post discharge remote ambulatory continuous electrocardiogram (ECG) monitoring using the novel Checkpoint Cardio System where it is clinically appropriate.",[28],[416],"Aortic Valve Stenosis, TAVI, Hydra",{"date":368,"type":39},{"date":419,"type":39},"2024-07-11",{"date":421,"type":22},"2026-08-01",{"name":423,"class":81},"Sahajanand Medical Technologies Limited",{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":18,"minAge":91,"maxAge":409,"enrollmentInfo":431,"targetDuration":412,"studyType":94,"phases":4,"briefSummary":433,"conditions":434,"keywords":435,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":437,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":161},"100542420","hydra-single-centre-experience---copenhagen-denmark-100542420","NCT06342635","Hydra Single-centre Experience - Copenhagen, Denmark","Prospective Observational Single-centre Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patients affected by severe aortic stenosis (NYHA class ≥ II) eligible for TAVI procedure as per local Heart Team evaluation\n3. Full understanding and willing to provide informed consent to study enrolment\n\nExclusion Criteria:\n\n1. Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)\n2. Refusal to provide informed consent to study enrolment\n3. Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI\n4. Patients with calcification on the annulus and in the Left Ventricular Outflow Tract (LVOT), or\u002Fand excess calcium within each cusp, or those who are deemed unsuitable for the Hydra THV series based on the clinical judgment of the Investigator",{"count":432,"type":22},50,"The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. Additionally, the study will assess the role of geometry in the development of new conduction abnormalities based on the analysis of post-operative CT scan at 1-month in patients who had undergone transcatheter aortic valve replacement with a self-expanding Hydra THV series.",[28],[28,151,436],"Hydra",{"date":368,"type":39},{"date":439,"type":39},"2024-06-18",{"date":441,"type":22},"2027-10-31",{"name":423,"class":81},{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":18,"minAge":91,"maxAge":409,"enrollmentInfo":450,"targetDuration":172,"studyType":94,"phases":4,"briefSummary":451,"conditions":452,"keywords":453,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":297},"100512761","hydra-registry---italy-experience-100512761","NCT05956652","Hydra Registry - Italy Experience","Observational Study on the Efficacy and Safety of Transcatheter Implantation of Hydra Biological Aortic Prosthesis","Inclusion Criteria:\n\n* Patients with severe symptomatic native aortic valve stenosis and candidates for the TAVI procedure based on the evaluation of the Heart Team\n* Ability to understand and provide informed consent for inclusion in the study\n\nExclusion Criteria:\n\n* Contraindication to TAVI: e.g. evidence of intracardiac mass, thrombus or vegetation, endocarditis.\n* Refusal by the patient to participate in the study\n* High probability of non-adherence to required follow-ups",{"count":199,"type":22},"Hydra-IT is a multicenter observational study aim to collect clinical, procedural and follow-up data and evaluate the short, medium and long term results of Hydra TAVI System in patient with severe aortic stenosis.",[28],[28,151,436],{"date":368,"type":39},{"date":456,"type":39},"2023-07-01",{"date":458,"type":22},"2029-07-31",{"name":423,"class":81},{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":18,"minAge":91,"maxAge":4,"enrollmentInfo":468,"targetDuration":470,"studyType":94,"phases":4,"briefSummary":471,"conditions":472,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":482},"100516163","ischemic-and-bleeding-risk-assessment-after-tavr-100516163","NCT06000943","Ischemic And Bleeding Risk Assessment After TAVR","Ischemic And Bleeding Risk Assessment After TAVR (FOCUS ONE Registry)","FOCUS ONE","Inclusion criteria\n\n* All patients with severe aortic stenosis undergoing TAVR.\n* Availability of changes in antithrombotic therapy at 1 month, 90 days, and 1 year after TAVR.\n\nExclusion Criteria\n\n* Patients who died during the index procedure\n* Patients in triple antithrombotic therapy at discharge\n* Patients with a known prognosis less than 1 year at the time of TAVR",{"count":469,"type":22},2500,"3 Years","Transcatheter aortic valve replacement (TAVR) represents an effective treatment to improve symptoms and prognosis in patients with symptomatic severe aortic stenosis (AS) (1-2).\n\nGiving an established uniform approach towards anticoagulation and antithrombotic therapy after TAVR in the post POPULAR-TAVI era, recent data coming from the analysis of different trials, highlight the relevance of the patient's background on the occurrence of ischemic and bleeding events.\n\nDespite this a targeted antithrombotic strategy remains unexplored and all patients undergoing TAVR without other indication to DAPT or OAC, were currently treated according with the concept of \"less is more\" (only SAPT or only OAC) regardless the risk level (5-6).\n\nThe keys points of the project will be 1) the assessment of ischemic and bleeding risk after TAVR stratified according with antithrombotic therapy and surgical risk; 2) the evaluation of the impact of prostheses type and the complete blood count variables (hemoglobine and platelets) on the daily average ischemic and bleeding risk and 3) the evaluation of the dynamic therapeutic changes after TAVR during the follow up.",[28,256],"2026-04-13",{"date":475,"type":39},"2026-04-16",{"date":477,"type":39},"2023-08-01",{"date":479,"type":22},"2026-12-15",{"name":481,"class":46},"Niguarda Hospital",12,{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":12,"sex":18,"minAge":91,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":161},"100499171","coronary-re-engagement-after-random-navitor-alignment-comfort-study-100499171","NCT05779787","COronary Re-engageMent aFter randOm NavitoR alignmenT (COMFORT STUDY)","COronary Re-EngageMent aFter RandOm NavitoR Alignment (COMFORT STUDY)","COMFORT","Patients to be included in this registry should have all the following criteria:\n\n1\\. Severe, symptomatic aortic stenosis with an indication to TAVI\n\nExclusion criteria and definition\n\nPatients excluded in this registry should have all the following criteria:\n\n1. Valve in Valve procedure\n2. Hemodynamical instability\n3. TAVR performed from other access (not femoral)\n4. No-CT Planned TAVR\n5. TAVR performed with Chimney Technique",{"count":145,"type":22},"Whereas PCI before TAVR was previously recommended despite its uncertain prognostic role, recent data underline the possibility of a postponed coronary intervention using a commissural alignment technique. This approach allows easy coronary re-engagement through the valve stent frame with a trade off paid of procedure complexity.\n\nConsidering the prevalence of coronary artery disease (CAD) and the increasing percentage of younger patients treated with TAVI, investigate whether a simpler procedure with random implantation of Navitor valve is not inferior in terms of coronary re-access, is required The key point of the project will be the evaluation of the feasibility of coronary re-engagement after a Navitor valve randomly implanted.",[28,256],{"date":475,"type":39},{"date":496,"type":39},"2023-02-15",{"date":498,"type":22},"2027-05-15",{"name":481,"class":46},{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":4,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":18,"minAge":91,"maxAge":507,"enrollmentInfo":508,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":510,"conditions":511,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":161},"100608729","detecting-changes-in-arterial-blood-volume-and-cardiac-efficiency-100608729","NCT07205341","Detecting Changes in Arterial Blood Volume and Cardiac Efficiency","A Pilot Clinical Study to Assess Correlation Between Arterial Blood Volume Status and Cardiac Efficiency, and HemoCept Device Data in Trans-Aortic Valve Replacement (TAVR} Surgery","Inclusion Criteria:\n\n* Subjects or representatives must have voluntarily signed the informed consent form before any study related procedures.\n* Subjects can be any gender but must be between (and including) the ages of 18 and 80.\n* Subject ls being treated by the participating healthcare facility .\n\n  ., Subject requires a trans-aortic valve replacement.\n* Subject is able and willing to provide informed consent and HIPM authorization.\n* Subject is able and willing to meet all study requirements.\n\nExclusion Criteria:\n\n* Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study.\n* Subject has a personal medical history that includes:\n\n  * Long O-T syndrome\n  * Cardiac channelopathies\n  * Seizures","80 Years",{"count":509,"type":22},20,"The objective of this Pilot Study is to demonstrate the efficacy of the Hemocept device in detecting changes in arterial blood volume and cardiac efficiency.",[28],"2026-04-09",{"date":473,"type":39},{"date":515,"type":39},"2025-04-29",{"date":517,"type":22},"2026-09",{"name":519,"class":81},"HemoCept Inc.",{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":526,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":18,"minAge":91,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":530,"conditions":531,"keywords":534,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":161},"100632974","impact-of-transcatheter-aortic-valve-implantation-and-mitral-valve-repair-on-sleep-disordered-breathing-100632974","NCT07520656","Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing","Impact of Transcatheter Aortic Valve Implantation and Transcatheter Mitral Valve Edge-to-Edge Repair on Sleep-Disordered Breathing","SLEEP-VALVE","Inclusion Criteria:\n\n* Adult patients undergoing TAVI or M-TEER\n* Ability to undergo polysomnography\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Inability to undergo sleep study (polysomnography)\n* Inability to complete follow-up at 6 months\n* Cognitive impairment (e.g., dementia)\n* Refusal to participate",{"count":529,"type":22},150,"This prospective observational study aims to investigate the impact of transcatheter aortic valve implantation (TAVI) and transcatheter mitral valve edge-to-edge repair (M-TEER) on sleep-disordered breathing (SDB) in patients with significant valvular heart disease. Patients undergoing TAVI or M-TEER will be evaluated with full polysomnography prior to the intervention and at 6 months follow-up. Changes in sleep parameters, including apnea-hypopnea index (AHI), central and obstructive apnea indices, oxygen desaturation, and sleep architecture, will be assessed. In addition, the study will explore the association between changes in SDB and echocardiographic as well as arrhythmic parameters. The findings are expected to improve the understanding of the interaction between valvular heart disease and SDB and to identify potential benefits of transcatheter interventions on sleep-related outcomes.",[532,28,533],"Sleep-disordered Breathing (SDB)","Mitral Valve Regurgitation",[535,536,537,538,539,540,541,542,543,544,545,546,547,548,549,550,551,552,553,554,555],"tavi","m-teer","sleep apnea","sleep disordered breathing","aortic stenosis","aortic valve","mitral regurgitation","AS","MR","mitral valve","transcatheter","sdb","sleep-disordered breathing","obstructive sleep apnea","osa","central sleep apnea","csa","transcatheter aortic valve implantation","mitral valve repair","MitraClip","valvular heart disease","2026-04-02",{"date":512,"type":39},{"date":559,"type":39},"2025-07-20",{"date":561,"type":22},"2029-09-01",{"name":563,"class":46},"Aristides Plaitis",{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":570,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":18,"minAge":91,"maxAge":572,"enrollmentInfo":573,"targetDuration":4,"studyType":23,"phases":575,"briefSummary":576,"conditions":577,"keywords":580,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":595},"100476720","miecc-versus-conventional-cardiopulmonary-bypass-in-cardiac-surgery-miecs-100476720","NCT05487612","MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)","Minimally Invasive Extracorporeal Circulation Versus Conventional Cardiopulmonary Bypass in Patients Undergoing Cardiac Surgery (MiECS): a Randomised Controlled Trial","MiECS","Inclusion Criteria:\n\n* All patients undergoing any elective or urgent coronary artery bypass grafting (CABG), aortic valve replacement (AVR) or CABG+AVR surgery using extracorporeal circulation without circulatory arrest.\n\nExclusion Criteria:\n\n* Requirement for emergency or salvage operation.\n* Requirement for major aortic surgery (e.g. aortic root replacement).\n* Contraindication or objection (e.g. Jehovah's Witnesses) to transfusion of blood products.\n* Congenital or acquired platelet, red cell or clotting disorders (patients with iron deficient anaemia will not be excluded).\n* Inability to give informed consent for the study (e.g. learning or language difficulties).","85 Years",{"count":574,"type":22},1300,[59],"MiECS is one of the largest multicentre randomised controlled trials on extracorporeal circulation conducted under the auspices of Minimal Invasive Extracorporeal Technologies International Society (MiECTiS). It is designed to ultimately address the emerging effectiveness of MiECC systems in the light of modern perfusion practice worldwide. The primary hypothesis is that MiECC, as compared to conventional CPB (cCPB), reduces the proportion of patients experiencing serious perfusion-related postoperative morbidity after cardiac surgery. The study will be led by the Clinical Research Unit of the Special Unit for Biomedical Research and Education (SUBRE), Aristotle University of Thessaloniki School of Medicine in Greece (AUSoM) with Chief Investigator Professor Kyriakos Anastasiadis, who is a key-opinion-leader in the field of MiECC, founder and Executive Board of MiECTiS.",[578,28,579],"Coronary Artery Disease","Extracorporeal Circulation; Complications",[581,582,583,584,585],"Cardiopulmonary bypass","Extracorporeal circulation","Minimal invasive extracorporeal circulation","Coronary artery bypass grafting","Aortic valve replacement","2026-03-27",{"date":588,"type":39},"2026-03-30",{"date":590,"type":39},"2022-05-26",{"date":592,"type":22},"2029-03-31",{"name":594,"class":46},"Aristotle University Of Thessaloniki",13,{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":601,"acronym":602,"eligibilityCriteria":603,"healthyVolunteers":12,"sex":18,"minAge":91,"maxAge":4,"enrollmentInfo":604,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":606,"conditions":607,"keywords":4,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":4},"100609481","observational-study-to-collect-data-of-patient-which-recieving-a-tavi-in-tavi-procedure-100609481","NCT07215143","Observational Study to Collect Data of Patient Which Recieving a TAVI in TAVI Procedure","Transcatheter Aortic Valve Implantation With Myval THV (OCTACOR\u002FOCTAPRO) in Patients With a Failing Successfully Im-planted First Transcatheter Heart Valve","REDO-TAVI","Inclusion Criteria:\n\n* A TAVI-in-TAVI procedure with implantation of the Myval THV (Oc-taCor\u002FOctaPRO) into a previously implanted (≥3 months) failing transcatheter heart valve of any kind is either planned, has al-ready been performed, or was attempted, based on a clinical indi-cation established by the treating heart team.\n* Age: 18 years or more\n* Informed consent has been obtained.\n\nExclusion Criteria:\n\n* Participation in an interventional clinical trial\n* Limited life expectancy \\\u003C12 months\n* Foreseeable problems in performing follow-up visits",{"count":605,"type":22},300,"Patients with aortic valve stenosis often undergo transcatheter aortic valve implantation (TAVI) today. This biological valve can wear out or leak over time. In such cases, a second catheter-based procedure may be necessary, in which a new valve is inserted into the old one - a so-called TAVI-in-TAVI procedure. This method is considered a gentle alternative to repeat open heart surgery.\n\nThe trial will include around 300 patients from several European centres who are scheduled to undergo or have already undergone a TAVI-in-TAVI procedure with the Myval valve. Participation includes follow-up observation for a period of up to five years. Data collection will take place exclusively within the framework of regular medical care. This includes information on pre-existing conditions, the procedure, complications and subsequent hospital stays. Imaging examinations such as echocardiography or CT scans can also be centrally evaluated if they are performed routinely.",[28],"2026-03-23",{"date":610,"type":39},"2026-03-24",{"date":612,"type":22},"2026-04",{"date":614,"type":22},"2033-06",{"name":616,"class":46},"IHF GmbH - Institut für Herzinfarktforschung",{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":4,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":18,"minAge":91,"maxAge":507,"enrollmentInfo":624,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":625,"conditions":626,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":627,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":161},"100548425","valve-performance-of-the-sapien-3-ultra-resilia-valve-a-prospective-registry-with-central-echocardiography-analysis-100548425","NCT06420830","Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.","Title Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.","Inclusion Criteria:\n\n* Inclusion criteria - Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve.\n* Successful valve implantation of the SAPIEN 3 Ultra RESILIA valve.\n\nVARC-3- defined technical success defined as:\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 to a major vascular or access related, or cardiac structural complication - Absence of severe procedural or in-hospital complications (VARC-3 definitions): mortality, stroke, bleeding type 2-4, myocardial infarction, need for a second valve, valve embolization, coronary obstruction, annular rupture.\n\nExclusion Criteria:\n\n* Age \\>80 years\n* Severe pulmonary disease (FEV1 \\\u003C50% predicted or need for home oxygen)\n* Severe renal dysfunction (eGFR \\\u003C30 ml\u002Fmin\u002F1.73m2)\n* Frailty (Clinical Frailty Scale \\> 4)\n* Severe coronary disease (SYNTAX score \\>32)\n* Left ventricular ejection fraction ≤30%\n* Moderate-to-severe mitral regurgitation\n* Severe tricuspid regurgitation\n* Pulmonary systolic pressure \\>60 mmHg\n* STS-PROM \\>5%\n* Any disease leading to a life expectancy \\\u003C5 years",{"count":529,"type":22},"The issue of valve durability has become one of the most important aspects in the TAVR field in recent years since transcatheter aortic valve replacement has been progressively applied to younger patients with a low co-morbidity burden. The SAPIEN 3 Ultra RESILIA valve represents the last generation of the SAPIEN valve system and includes several important iterations (newer leaflet calcium-blocking technology targeting calcium-attracting free aldehydes, dry tissue storage, newer skirt textile design) that should translate into a favorable impact on valve durability at mid- to long- term follow-up",[28,256],{"date":586,"type":39},{"date":629,"type":39},"2024-05-16",{"date":631,"type":22},"2034-09-01",{"name":633,"class":46},"Institut universitaire de cardiologie et de pneumologie de Québec, University Laval",{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":640,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":18,"minAge":91,"maxAge":4,"enrollmentInfo":642,"targetDuration":4,"studyType":23,"phases":644,"briefSummary":645,"conditions":646,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":649,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":653,"locationsCount":654},"100474540","valve-hemodynamic-optimization-based-on-doppler-echocardiography-vs-catheterization-measurements-following-viv-tavr-100474540","NCT05459233","Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR","Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial","ECHOCATH","Inclusion Criteria:\n\n* Patients with surgical aortic bioprosthetic valve failure defined as severe aortic stenosis and\u002For regurgitation approved for a valve-in-valve procedure by the Heart Team\n* Surgical stented bioprosthetic valve (label size ≤25 mm)\n* TAVR with the SAPIEN 3 Ultra valve\n\nExclusion Criteria:\n\n* Stentless or sutureless surgical valves\n* Trifecta bioprosthesis\n* Hancock II bioprosthesis\n* High-risk of coronary obstruction (defined either as a virtual transcatheter valve - coronary distance as evaluated by CT \\\u003C4 mm or based on the criterion of the heart team responsible for the procedure).\n* Impossibility to obtain written informed consent",{"count":643,"type":22},310,[59],"Data on valve performance following ViV-TAVR has usually been obtained with the use of Doppler-echocardiography. However, some reports have shown significant discordances in the evaluation of mean transvalvular gradient between echocardiography and catheterization, with an overestimation of the real gradient with echo (vs. cath) in most cases. Thus, the incidence of procedural-device failure may be lower than that reported in the ViV-TAVR literature,",[28,647,648],"Aortic Valve Regurgitation","Prosthesis Failure",{"date":610,"type":39},{"date":651,"type":39},"2023-01-11",{"date":561,"type":22},{"name":633,"class":46},7]