[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"severe-aortic-valve-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:severe-aortic-valve-stenosis":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,49,81,106,126,149,174,196,219,242,263],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100582126","in-vitro-benchmarking-of-currently-available-heart-valve-prostheses-for-surgical-and-percutaneous-treatment-of-aortic-stenosis-with-small-annulus-followed-by-in-vivo-validation-100582126",false,"NCT06859255","In-vitro Benchmarking of Currently Available Heart Valve Prostheses for Surgical and Percutaneous Treatment of Aortic Stenosis With Small Annulus, Followed by In-vivo Validation","SurPASS","Inclusion Criteria:\n\n* patients who underwent SAVR or TAVI for severe aortic stenosis\n* implanted with valve models and sizes among those which we evaluated in vitro\n\nExclusion Criteria:\n\n* treated or untreated aortic root\u002Fascending aorta aneurysm\n* preoperative aortic regurgitation more than moderate\n* recent (\\\u003C12 weeks)\u002F concomitant revascularization\n* recent (\\\u003C12 weeks) ACS\n* PPI (permanent pacemaker implantation)\n* other than sinus rythm\n* Paravalvular leak (PVL) \\> moderate.","ALL",{"count":18,"type":19},200,"ESTIMATED","INTERVENTIONAL",[22],"NA","The general objective of this study is to compare in vitro and in vivo the hemodynamic performance of different types of aortic valve prostheses and possible surgical implantation techniques.\n\nThe study involves the collection of data deriving from tests and procedures foreseen by normal clinical practice, including a transthoracic color Doppler echocardiogram, to which is added a 4DFlow cardiac MRI (magnetic resonance imaging) without contrast medium, to be performed between 1 and 3 months after the operation.\n\nThe study will last 24 months and the patients involvement will end approximately 1-3 months after the intervention.\n\nThere are no direct benefits expected from participation in the study. However, the instrumental data obtained by echocardiogram and Magnetic Resonance Imaging will be useful for monitoring the medium-term surgical outcome of patients after surgery.",[25],"Severe Aortic Valve Stenosis",[27,28,29,30,31,32,33,34,35],"aortic valve stenosis","valve replacement","TAVI","hemodynamic","4d flow","cardiac echo","cardiac RMN","aortic valve","TAVR","RECRUITING","2026-07-01",{"date":39,"type":40},"2026-07-02","ACTUAL",{"date":42,"type":40},"2025-02-07",{"date":44,"type":19},"2027-02-07",{"name":46,"class":47},"IRCCS Policlinico S. Donato","OTHER",2,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":20,"phases":61,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100529022","personalized-ct-guided-antithrombotic-therapy-versus-lifelong-single-antiplatelet-therapy-to-reduce-thromboembolic-and-bleeding-events-in-non-atrial-fibrillation-patients-after-transcatheter-aortic-valve-implantation-100529022","NCT06168370","Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Reduce Thromboembolic and Bleeding Events in Non-atrial Fibrillation Patients After Transcatheter Aortic Valve Implantation","Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Reduce Thromboembolic and Bleeding Events in Non-atrial Fibrillation Patients After Transcatheter Aortic Valve Implantation: a Pragmatic, International, Multicentre, Randomized Clinical Trial","POP ATLANTIS","Inclusion Criteria:\n\n* Successful TAVI (according to the VARC-3 criteria)10 with any approved device\n* Ability to understand and to comply with the study protocol\n* Written informed consent\n\nExclusion Criteria:\n\n* Existing indication for oral anticoagulation (e.g. atrial fibrillation, obstructive valve thrombosis detected by echocardiography prior to inclusion)\n* Existing indication for dual antiplatelet therapy at three months after TAVI (rare at this time point)\n* Creatinine clearance \\\u003C15 mL\u002Fmin (based on the CKD-EPI formula) or on renal replacement therapy","18 Years","110 Years",{"count":60,"type":19},2500,[22],"The POPular ATLANTIS trial aims to investigate CT-guided antithrombotic therapy compared to lifelong single antiplatelet therapy after a transcatheter aortic valve implantation (TAVI) procedure. Only patients without an indication for anticoagulants will be included in this trial. Currently, lifelong single antiplatelet therapy (mostly aspirin) is considered the standard of care for these patients. However, this approach poses a bleeding risk with only a minimal reduction in thromboembolic events.\n\nAfter 3 months, a CT scan will be conducted to assess the presence of thrombosis on the newly implanted TAVI valve. Based on the results of a 4D CT scan, the decision will be made whether the patient should receive no anticoagulant or antithrombotic therapy with apixaban. CT-guided antithrombotic therapy holds the potential for a greater reduction in thromboembolic events without increasing the bleeding risk.",[25],[65,66,67,68,69,70],"aortic stenosis","bleeding","tavi","ct","personalized antithrombotic therapy","tavr","2026-05-18",{"date":73,"type":40},"2026-05-19",{"date":75,"type":40},"2023-12-01",{"date":77,"type":19},"2028-12-01",{"name":79,"class":47},"St. Antonius Hospital",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":88,"targetDuration":90,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"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":89,"type":19},100,"12 Months","OBSERVATIONAL","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.",[25,94,95],"Valvular Heart Disease","Aortic Valve Stenosis","NOT_YET_RECRUITING","2026-04-27",{"date":99,"type":40},"2026-05-05",{"date":101,"type":19},"2026-06-01",{"date":103,"type":19},"2029-02-01",{"name":105,"class":47},"Fundación EPIC",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":35,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":20,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":80},"100634875","ultra-evolut-rct-a-comparison-of-latest-generation-tavr-valves-100634875","NCT07545369","ULTRA-EVOLUT RCT: A Comparison of Latest-Generation TAVR Valves","The ULTRA-EVOLUT Randomized Control Trial: A Head-to-Head Comparison of Latest-Generation Transcatheter Aortic Valves","Inclusion Criteria:\n\n* Severe aortic stenosis defined as aortic valve area (AVA) ≤1.0 cm², mean transvalvular gradient ≥40 mmHg, or peak transvalvular velocity ≥4.0 m\u002Fs\n* Symptomatic with New York Heart Association (NYHA) functional class II, III, or IV\n* Heart team consensus that transcatheter aortic valve implantation (TAVI) is the appropriate treatment strategy\n* Anatomically suitable for both valve types (SAPIEN 3 Ultra Resilia and Evolut FX) as determined by pre-procedural computed tomography (CT) imaging\n* Age ≥18 years\n* Able and willing to provide written informed consent\n* Able and willing to comply with all scheduled follow-up visits and assessments\n\nExclusion Criteria:\n\n* Bicuspid aortic valve morphology\n* Severe mitral regurgitation or severe tricuspid regurgitation requiring intervention\n* Prior surgical or transcatheter aortic valve replacement\n* Active infective endocarditis\n* Contraindication to dual antiplatelet therapy or anticoagulation\n* Estimated life expectancy less than 1 year due to non-cardiac comorbidities\n* Pregnancy or breastfeeding",{"count":18,"type":19},[22],"Title:\n\nThe ULTRA-EVOLUT Randomized Control Trial: A Head-to-Head Comparison of Latest-Generation Transcatheter Aortic Valves\n\nBrief Summary:\n\nThe goal of this clinical trial is to compare the latest-generation balloon-expandable (SAPIEN 3 Ultra Resilia) versus self-expanding (Evolut FX) transcatheter aortic valves in patients with severe, symptomatic aortic stenosis who are undergoing transcatheter aortic valve implantation (TAVI).\n\nThe main questions it aims to answer are:\n\nDoes device success rate (defined by VARC-3 criteria) at 30 days differ between the SAPIEN 3 Ultra Resilia and the Evolut FX valves? Do hemodynamic performance (mean gradient, effective orifice area) and incidence of moderate\u002Fsevere paravalvular leak differ between the two valve types at 30 days and 1 year? Researchers will compare patients randomized to receive the SAPIEN 3 Ultra Resilia valve versus patients randomized to receive the Evolut FX valve to see if there are differences in device success, safety outcomes, and valve performance.\n\nParticipants will:\n\nUndergo standard pre-procedural clinical, echocardiographic, and CT assessment Be randomly assigned to receive either the SAPIEN 3 Ultra Resilia or Evolut FX valve during their clinically indicated TAVI procedure Receive post-procedure follow-up assessments including echocardiography and clinical evaluation at 24 hours, 30 days, 6 months, and 1 year",[25],"2026-04-16",{"date":119,"type":40},"2026-04-22",{"date":121,"type":19},"2026-09-12",{"date":123,"type":19},"2027-12-12",{"name":125,"class":47},"Assiut University",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":20,"phases":134,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":80},"100628026","evaluation-of-the-non-invasive-electrocardiographic-monitoring-strategy-associated-with-early-discharge-in-patients-with-conduction-disorder-through-tavi-implantation-100628026","NCT07456280","Evaluation of the Non-invasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorder Through TAVI Implantation","IMPROVE","Inclusion Criteria:\n\nAll inclusion criteria must be met\n\n* Age ≥ 18 years and\n* Undergone successful transfemoral or transaortic TAVI for severe aortic stenosis and\n* Presence of at least one of the following conduction disorders and\n* Pre-procedural basal conduction disorder (e.g., right\u002Fleft bundle branch block, bifascicular block, IVCD) with QRS between 120-160 msec.\n* De novo conduction disorder after TAVI (de novo bundle branch block) with QRS between 120-160 msec.\n* Clinical stability at 24 hours post-procedure and\n* Capacity to give informed consent.\n\nExclusion Criteria:\n\nNo exclusion criteria must be met\n\n* Immediate indication for permanent pacemaker following the procedure.\n* Persistent complete atrioventricular block.\n* QRS \\>160 msec and\u002For PR prolongation.\n* Haemodynamic instability or complications of TAVI (major bleeding, stroke, decompensated heart failure) that contraindicate early discharge.\n* Technical or clinical impossibility of using the PhysioMem PM 1004G monitoring system.\n* Life expectancy \\\u003C 12 months due to non-cardiovascular comorbidity.\n* Refusal or inability to undergo outpatient follow-up.\n* Pregnant or breastfeeding.",{"count":89,"type":19},[22],"Study to evaluate the efficacy and safety of a non-invasive electrocardiographic monitoring strategy associated with early discharge in patients with conduction disorder after transfemoral TAVI implantation, and its potential benefits compared to standard care.",[25,137],"Cardiovascular Diseases",[139],"TAVI(Transcatheter Aortic Valve Implantation)","2026-03-04",{"date":142,"type":40},"2026-03-06",{"date":144,"type":19},"2026-04-01",{"date":146,"type":19},"2028-08-01",{"name":148,"class":47},"Hospital Universitari Vall d'Hebron Research Institute",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":20,"phases":158,"briefSummary":159,"conditions":160,"keywords":161,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":80},"100618767","a-clinical-study-using-fapi-pet-imaging-to-assess-the-postoperative-effects-of-tavi-in-patients-with-aortic-stenosis-100618767","NCT07335900","A Clinical Study Using FAPI-PET Imaging to Assess the Postoperative Effects of TAVI in Patients With Aortic Stenosis","A Clinical Study Using FAPI-PET Imaging to Evaluate the Effects of TAVI on Reversing Myocardial Structural and Functional Remodeling in Patients With Aortic Stenosis","Inclusion Criteria:\n\n① Age 18 years or older, any gender; ② Confirmed diagnosis of severe degenerative aortic stenosis by echocardiography (valve area AVA \\\u003C 1.0 cm² or mean transvalvular gradient \\> 40 mmHg; for AS with reduced ejection fraction and low-flow, low-gradient, the presence of outflow tract reserve must be confirmed with dobutamine stress); ③ Evaluated by the heart team as unsuitable for surgical open-heart valve replacement due to advanced age or severe comorbidities, without anatomical contraindications, and expected to benefit from transcatheter valve implantation. Patients who meet these criteria and decide to undergo TAVI will be assigned to the TAVI group; those who meet the criteria but do not undergo valve replacement will enter the control group (possible scenarios include: relatively mild valve stenosis not meeting TAVI indication, or patient refusal of surgery, opting for drug therapy only, etc.).\n\nExclusion Criteria:\n\n* Recent acute myocardial infarction (less than 1 month from onset to enrollment) or the presence of active myocarditis, infectious endocarditis, and other acute inflammatory conditions, as these conditions can significantly affect FAPI uptake and cardiac function; ② History of old myocardial infarction (with existing myocardial scarring and remodeling, which affect fibroblast imaging); ③ Presence of uncontrolled severe arrhythmias, such as persistent ventricular tachycardia, ventricular fibrillation, or high-risk second-degree or higher atrioventricular block, resulting in hemodynamic instability due to arrhythmia within the past 3 months; ④ Concomitant severe cardiovascular diseases affecting study evaluation, including severe valvular disease (excluding AS, such as severe mitral regurgitation), hypertrophic obstructive cardiomyopathy, primary pulmonary hypertension, etc.; ⑤ Presence of examination contraindications: allergy to PET tracers or MRI contrast agents, severe renal insufficiency (eGFR \\\u003C30 ml\u002Fmin\u002F1.73 m²) with inability to tolerate gadolinium-enhanced MRI, or severe claustrophobia preventing compliance with imaging examinations; ⑥ Allergic constitution (history of allergy to multiple drugs or unknown substances); ⑦ Pregnant or breastfeeding women (female subjects of childbearing potential must provide a negative pregnancy test before enrollment and use effective contraception during the study); ⑧ Any other situation that the investigator believes could significantly increase study risk or interfere with result interpretation, such as active malignant tumors or advanced disease with expected survival of less than 1 year; ⑨ Inability to comply with the trial protocol or follow-up requirements (e.g., poor prior adherence, expected inability to attend scheduled follow-ups).",{"count":157,"type":19},25,[22],"This study will include patients with severe degenerative aortic stenosis (AS) who meet the inclusion criteria and voluntarily participate (planned to undergo TAVI), as well as patients with aortic stenosis who have not undergone valve replacement (control group). All enrolled patients will undergo a \\^18F-FAPI-1801 PET\u002FCT scan at baseline (before or at the time of TAVI) and 6 months postoperatively to quantitatively evaluate myocardial fibroblast activation and structural remodeling indicators, and to follow up on changes in clinical cardiac function. Patients with aortic stenosis receiving only medical therapy will be set as the control group for comparative analysis, to assess the impact of relieving aortic stenosis on the reduction of myocardial fibrosis activity, myocardial remodeling, and reversal of cardiac function.",[25],[162,163,164],"Severe aortic valve stenosis","Transcatheter Aortic Valve Replacement","FAPI-PET","2026-01-12",{"date":167,"type":40},"2026-01-13",{"date":169,"type":19},"2025-12-19",{"date":171,"type":19},"2027-05-30",{"name":173,"class":47},"RenJi Hospital",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":20,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":48},"100481695","vrap-heart---virtual-reality-assisted-patient-empowerment-for-interventions-in-structural-heart-disease-100481695","NCT05552352","VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease","VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease - A Randomized-Controlled Multicenter Study","VRAP-Heart","Inclusion Criteria:\n\n* High-grade aortic valve stenosis\n* Indication for elective transfemoral transcatheter aortic valve implantation under analgesia (TAVI)\n* Existing heart center decision\n* Age ≥ 18 years\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Surgery planned under general anesthesia\n* Language barrier, defined as insufficient language proficiency at the discretion of the investigator to understand the purpose of the trial and follow the VR application.\n* Severe hearing impairment, preventing the patient from understanding the sound of the VR goggles, tested with the VR goggles fitted without using the VRAP-Heart software\n* Severe visual impairment that prevents viewing of the VR modules if it is not possible to use existing visual corrections (contact lenses, glasses) together with the VR glasses in the event of defective vision, tested with the VR goggles fitted without using the VRAP-Heart software\n* Moderately severe or severe dementia syndrome noted in the medical history or identified during the informed consent discussion\n* Known seizure disorder (epilepsy)\n* Positive pregnancy test on inclusion and\u002For pregnancy is present\n* Court ordered placement in an institution\n* Any psychosocial condition that makes compliance with the protocol unlikely",{"count":183,"type":19},300,[22],"This prospective, randomized-controlled multicenter study investigates whether virtual reality-assisted patient education in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) can improve patient understanding and simulative orientation, thereby reducing postinterventional complications, resulting in significantly shorter length of stay.",[25],"2025-08-22",{"date":189,"type":40},"2025-08-28",{"date":191,"type":40},"2022-10-05",{"date":193,"type":19},"2027-02-28",{"name":195,"class":47},"Heinrich-Heine University, Duesseldorf",{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":203,"maxAge":4,"enrollmentInfo":204,"targetDuration":90,"studyType":91,"phases":4,"briefSummary":206,"conditions":207,"keywords":208,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":80},"100601283","a-prospective-multicenter-observational-study-of-the-safety-and-efficacy-of-emergency-transcatheter-aortic-valve-replacement-in-patients-with-severe-aortic-stenosis-100601283","NCT07108478","A Prospective, Multicenter, Observational Study of the Safety and Efficacy of Emergency Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis","E-TAVR-2025","Inclusion Criteria:\n\n1. Patients with severe aortic stenosis diagnosed at the clinic: peak transvalvular flow velocity ≥4.0m\u002Fs, or mean transvalvular pressure difference ≥40mmHg(1 mmHg=0.133kPa), or aortic valve orifice area \\\u003C \\\u003C0.8cm2 (or effective aortic valve orifice area index \\\u003C 0.5 cm2\u002Fm2);\n2. Meet one of the following emergent TAVR indications:\n\n1\\) Shock; 2) Combined with persistent ventricular tachycardia or ventricular fibrillation; 3) Difficulty in improving unstable angina pectoris or chronic heart failure requiring mechanical circulatory assistance with drugs; 4) Cardiopulmonary resuscitation is required for cardiac arrest; 3. Patients who can understand the purpose of the study, voluntarily participate in and sign the informed consent form, and are willing to accept the relevant examinations and clinical follow-up.\n\nExclusion Criteria:\n\n1. Aortic root anatomy and lesions are not suitable for prosthetic valve implantation;\n2. Anatomic morphology or vascular diseases affecting the instrument approach;\n3. Left ventricular outflow tract obstruction;\n4. Primary dilated cardiomyopathy;\n5. Thrombus in the left ventricle;\n6. Patients who are unable to receive anticoagulation or antiplatelet therapy;\n7. Allergy to or resistance to Nitinol;\n8. Active stage of infective endocarditis or other infection that the researcher believes affects the operation;\n9. Severe disability senile dementia;\n10. Patients with a life expectancy of less than half a year;\n11. The investigator determined that the patient or family had poor compliance or declined to complete the study as required.","70 Years",{"count":205,"type":19},35,"The research name of this project is: A prospective, multicenter and observational study on the safety and effectiveness of emergency transcatheter aortic valve replacement (TAVR) in the treatment of patients with severe aortic stenosis. It is a prospective, multi-center clinical study, and 35 cases are planned to be enrolled and followed up for 12 months (before discharge, 30 days, 6 months and 12 months). The research instruments used are VitaFlow Liberty® transcatheter aortic valve and recoverable delivery system. The purpose of this study is to evaluate the safety and effectiveness of emergency TAVR in patients with severe aortic stenosis. The main end point is the cumulative all-cause mortality 12 months after operation, and the secondary end points mainly include adverse cerebrovascular events (MACCE), acute renal injury, implantation rate of permanent pacemaker and valve function.",[25],[25,35,209],"emergency","2025-08-06",{"date":212,"type":40},"2025-08-07",{"date":214,"type":19},"2025-07-30",{"date":216,"type":19},"2028-12-30",{"name":218,"class":47},"Qilu Hospital of Shandong University",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":227,"targetDuration":90,"studyType":91,"phases":4,"briefSummary":229,"conditions":230,"keywords":231,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":80},"100586568","mylead-spanish-prospective-registry-100586568","NCT06917066","MYLEAD Spanish Prospective Registry","Spanish Prospective Registry: MYval Induced Late and EArly Conduction Disturbances (MYLEAD)","MYLEAD","Inclusion Criteria:\n\n* Adult patients (over 18 years of age)\n* Patients with Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve.\n\nExclusion Criteria:\n\n* Patients with pre-existing permanent pacemaker.\n* Patients unable or unwilling to follow up for pre and post procedure clinical assessments and investigations.",{"count":228,"type":19},500,"Investigator-initiated, prospective, multicentre registry, whose objectives are: 1\u002F to evaluate the incidence of conduction defects and the need of pacemaker implantation post-procedure, at discharge, at 30 days and at 1 year post Myval transcatheter heart valve deployment, and 2\u002F To evaluate the factors determining in-hospital and late (at 30 days and 1 year) conduction defects post Myval transcatheter heart valve.\n\nPatients with Severe Aortic stenosis undergoing TAVR using Myval Transcatheter Heart Valve that meet all inclusion criteria and any exclusion criteria will be able to participate in this study if they sign the informed consent. Electrocardiogram, echocardiogram and computed tomography will be performed to patients at different time points (Baseline, post-procedure, discharge, 30 days and 1 year post procedure) and their parameters will be added into a dedicated REDCAP database.",[25],[25,35,232],"Myval Transcatheter Heart Valve","2025-04-01",{"date":235,"type":40},"2025-04-08",{"date":237,"type":40},"2024-10-23",{"date":239,"type":19},"2026-12",{"name":241,"class":47},"Hospital Clínico Universitario de Valladolid",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":249,"targetDuration":251,"studyType":91,"phases":4,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":80},"100529003","future-optimal-research-and-care-evaluation---aortic-stenosis-100529003","NCT06168123","Future Optimal Research and Care Evaluation - Aortic Stenosis","FORCE-AoS","Inclusion Criteria:\n\n* Older than 18 years of age\n* Severe or moderate aortic stenosis\n\nNo exclusion criteria are applicable to this registry",{"count":250,"type":19},800,"4 Years","In the past decade the treatment of aortic valve stenosis has rapidly changed. At first, transcatheter aortic valve implantation (TAVI) was a last resort option for inoperable patients. Nowadays, it more and more becomes an alternative to surgical aortic valve replacement (SAVR) - also in younger and lower risk patients. This poses important questions to clinical practise regarding the optimal life-time management of each individual patient. Which involves (durability of) treatment modality (surgical vs. transcatheter vs. conservative treatment) as well as the duration and type of the required antithrombotic treatment.\n\nObjective: to evaluate the effect of treatment modality (surgical vs. transcatheter vs. conservative treatment) and its complications on quality of life and survival in AoS patients.",[25,254],"Moderate Aortic Valve Stenosis","2024-11-28",{"date":257,"type":40},"2024-12-03",{"date":259,"type":40},"2023-11-27",{"date":261,"type":19},"2027-08-01",{"name":79,"class":47},{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":20,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":4},"100438358","multi-center-registry-of-transcatheter-aortic-valve-replacement-in-northeast-china-100438358","NCT04988243","Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China","Inclusion Criteria:\n\n1. Severe aortic valve stenosis, defined as follows:\n\n   1. Symptomatic patients:\n\n      * The mean differential pressure measured by echocardiography ≥ 40mm Hg\n      * Or peak aortic ejection ≥ 4.0 m \u002F S\n      * Or aortic valve area ≤ 1.0cm ²（ Or AVA index ≤ 0.6 cm2 \u002F m2)\n   2. Asymptomatic patients:\n\n      * Severe aortic stenosis and aortic valve area ≤ 1.0cm ²（ 6 cm2 \u002F m2) with aortic ejection peak value ≥ 5.0 M \u002F s or mean pressure difference measured by --echocardiography ≥ 60 mm Hg;\n      * Or aortic valve area ≤ 1.0cm ²（ Or AVA index ≤ 0.6 cm2 \u002F m2), combined with aortic ejection peak ≥ 4.0 m \u002F s or average differential pressure measured by echocardiography ≥ 40 mm Hg, combined with limited exercise tolerance test, abnormal blood pressure response or arrhythmia;\n      * Or aortic valve area ≤ 1.0cm ²（ Or AVA index ≤ 0.6 cm2 \u002F m2), combined with aortic ejection peak ≥ 4.0 m \u002F s or average differential pressure measured by echocardiography ≥ 40 mm Hg, combined with LVEF \\\u003C 50%\n2. Subjects who plan (or have) to use the transcatheter aortic valve replacement system for percutaneous aortic valve replacement\n3. The patients agreed to join the study, voluntarily signed the informed consent and completed the follow-up;\n4. Be able to contact the subjects or their legal guardians \u002F relatives;\n5. The medical record records the subjects who have died and can't get any contact information of the subjects（ (for dead cases only)\n\nNote: for dead subjects, they must meet 1, 2 and 5 at the same time before they can be included in the group.\n\nExclusion Criteria:\n\n1. Contraindications to any artificial biological valve implantation;\n2. Any known allergies or contraindications;\n\n   * Aspirin or heparin and bivalirudin;\n   * Tigrelol and clopidogrel;\n   * Nickel titanium alloy;\n   * Contrast medium;\n3. The patient is currently participating in drug or device research;\n4. The patient is pregnant or lactating;\n5. Aortic annulus diameter \\\u003C 17 mm or \\> 32 mm;\n6. The diameter of approach vessel was less than 5.0mm;\n7. The investigator believes that the patient is not suitable to participate in this study or complete the follow-up specified in the protocol;",{"count":270,"type":19},320,[22],"The purpose of this study was to observe the safety and effectiveness of transcatheter aortic valve replacement in patients with aortic valve stenosis in a real-world clinical practice environment.",[25],"2021-08-01",{"date":276,"type":40},"2021-08-03",{"date":278,"type":19},"2021-08",{"date":280,"type":19},"2028-08",{"name":282,"class":283},"CCRF Inc., Beijing, China","INDUSTRY"]