[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594210":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":32,"responsibleParty":165,"collaborators":168,"id":172,"slug":173,"hasResults":174,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":174,"sex":180,"minAge":181,"maxAge":10,"enrollmentInfo":182,"targetDuration":185,"studyType":186,"phases":10,"briefSummary":187,"conditions":188,"keywords":192,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},{"fullName":5,"class":6},"Semmelweis University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Aortic stenosis",null,"Patients with aortic valve disease for whom transcatheter aortic valve implantation is indicated and who present for pre-interventional evaluation will be enrolled after written consent.",[13],"Diagnostic Test: Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography","Clinically indicated Ultra-High Resolution Photon-Counting Detector Coronary Computed Tomography Angiography (UHR PCD-CT CCTA) for the pre-procedural evaluation of patients scheduled to undergo transcatheter aortic valve implantation.",[9],[21],"Photon-Counting Detector CT (Naeotom Alpha, Siemens Healthineers)",[23],{"name":24,"affiliation":5,"role":25},"Pál Maurovich-Horvat, MD, PhD, DSc","PRINCIPAL_INVESTIGATOR",[27],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","+3614591500","61628","maurovich-horvat.pal@semmelweis.hu",[33,55,74,91,108,125,145],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Medical University of South Carolina","RECRUITING","Charleston","South Carolina","29425","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-79.93275,32.77632,{"lat":45,"lon":44},[48,52,54],{"name":49,"role":28,"phone":50,"phoneExt":10,"email":51},"Akos Varga-Szemes, MD, PhD","+1843-876-7146","vargaasz@musc.edu",{"name":53,"role":25,"phone":10,"phoneExt":10,"email":10},"U. 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Zürich","Zurich","8091","Switzerland","CH",{"type":42,"coordinates":152},[153,154],8.55,47.36667,{"lat":154,"lon":153},[157,161,163],{"name":158,"role":28,"phone":159,"phoneExt":10,"email":160},"Hatem Alkadhi, MD","+41 44 255 36 62","hatem.alkadhi@usz.ch",{"name":162,"role":107,"phone":10,"phoneExt":10,"email":10},"Mihaly Károlyi, MD",{"name":164,"role":107,"phone":10,"phoneExt":10,"email":10},"Victor Mergen, MD",{"type":25,"investigatorFullName":166,"investigatorTitle":167,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Prof. Maurovich-Horvat Pál","PhD, MPH, DSc, Director of Medical Imaging Centre, Chairman of Radiology",[169],{"name":170,"class":171},"Siemens Corporation, Corporate Technology","INDUSTRY","100594210","prospective-registry-of-patients-undergoing-cardiac-ct-with-naeotom-alpha-pcd-ct-before-tavi-procedure-100594210",false,"NCT07016477","Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha PCD-CT Before TAVI Procedure","Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha Photon Counting-detector CT Before Transcatheter Aortic Valve Implantation","Alpha Registry","Inclusion Criteria:\n\n* Clinically indicated TAVI\n* Clinically indicated CT and invasive coronary angiography\n* There are no contraindications to CT angiography.\n* Understanding and signing the consent form\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Chronic renal failure (eGFR \\\u003C30 ml\u002Fm2)\n* Active oncological treatment\n* Any condition for which TAVI is contraindicated and therefore no prior radiological investigation of TAVI is indicated","ALL","18 Years",{"count":183,"type":184},1000,"ESTIMATED","5 Years","OBSERVATIONAL","The clinical and demographic characteristics of patients undergoing transcatheter aortic valve implantation (TAVI) pose unique challenges for coronary computed tomography (CT) imaging, as this patient population is mainly composed of elderly, frail individuals with severe aortic stenosis, multiple comorbidities, high prevalence of heavily calcified coronary artery disease (CAD) and revascularized coronary arteries. Such vulnerable patients could benefit from a more precise assessment and characterization of their CAD with ultra-high resolution (UHR) photon-counting detector (PCD) CT that would potentially avoid the need for pre-implantation invasive coronary angiography (ICA). This international multicenter prospective registry study aims to investigate the feasibility and diagnostic accuracy of PCD-CT in the assessment of CAD in the high-risk population of patients undergoing TAVI, as compared to ICA.",[189,190,191],"Coronary Artery Disease","Aortic Valve Stenosis","Tomography, X-Ray Computed",[193],"photon-counting detector computed tomography","2025-06-04",{"date":196,"type":197},"2025-06-11","ACTUAL",{"date":199,"type":197},"2024-06-01",{"date":201,"type":184},"2030-05-30",{"name":5,"class":6},7]