[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497547":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":33,"responsibleParty":88,"collaborators":91,"id":98,"slug":10,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":10,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":10,"enrollmentInfo":106,"targetDuration":10,"studyType":109,"phases":10,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"St. Antonius Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intra-annular",null,"Patients with an intra-annular Sapien TAVI prosthesis",[13],"Diagnostic Test: 18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE)",{"label":15,"type":10,"description":16,"interventionNames":17},"Supra-annular","Patients with a supra-annular CoreValve Evolut TAVI prosthesis",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE)","Patients undergo a hybrid 18F-NaF-PET CT scan and TTE at five years after TAVI",[9,15],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Dirk-Jan van Ginkel, MD","CONTACT","+31 (0)88 320 66 48","d.van.ginkel@antoniusziekenhuis.nl",{"name":31,"role":27,"phone":10,"phoneExt":10,"email":32},"Prof. J.M. ten Berg, MD, PhD, MSc","jurtenberg@gmail.com",[34,48,64,75],{"facility":35,"status":36,"city":37,"state":10,"zip":10,"country":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Rigshospitalet","RECRUITING","Copenhagen","Denmark",{"type":40,"coordinates":41},"Point",[42,43],12.56553,55.67594,{"lat":43,"lon":42},[46],{"name":47,"role":27,"phone":10,"phoneExt":10,"email":10},"Prof. O. De Backer, MD, PhD",{"facility":5,"status":36,"city":49,"state":50,"zip":51,"country":52,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Nieuwegein","Utrecht","3435 CM","Netherlands",{"type":40,"coordinates":54},[55,56],5.08056,52.02917,{"lat":56,"lon":55},[59,60,62],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},{"name":31,"role":61,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":63,"role":61,"phone":10,"phoneExt":10,"email":10},"Dr. M.J. Swaans, MD, PhD",{"facility":65,"status":36,"city":66,"state":10,"zip":10,"country":52,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Amsterdam UMC","Amsterdam",{"type":40,"coordinates":68},[69,70],4.88969,52.37403,{"lat":70,"lon":69},[73],{"name":74,"role":27,"phone":10,"phoneExt":10,"email":10},"Dr. R. Delewi, MD, PhD",{"facility":76,"status":77,"city":78,"state":10,"zip":10,"country":79,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"University of Edinburgh","NOT_YET_RECRUITING","Edinburgh","United Kingdom",{"type":40,"coordinates":81},[82,83],-3.19648,55.95206,{"lat":83,"lon":82},[86],{"name":87,"role":27,"phone":10,"phoneExt":10,"email":10},"Prof. M. Dweck, MD, PhD",{"type":61,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Jurriën M. ten Berg, MD, PhD","MD, PhD, MSc",[92,95],{"name":93,"class":94},"St. Antonius Research Fund","UNKNOWN",{"name":96,"class":97},"Medtronic","INDUSTRY","100497547",false,"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)","ALL","18 Years",{"count":107,"type":108},180,"ESTIMATED","OBSERVATIONAL","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.",[112],"Aortic Valve Stenosis",[114,115,116,117,9,15],"TAVI","TAVR","Subclinical Leaflet Thrombosis","Bioprosthetic Valve Deterioration","2026-05-18",{"date":120,"type":121},"2026-05-19","ACTUAL",{"date":123,"type":121},"2023-11-16",{"date":125,"type":108},"2026-10-01",{"name":5,"class":6},4]