[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596213":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":190,"collaborators":25,"id":194,"slug":195,"hasResults":196,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":15,"eligibilityCriteria":200,"healthyVolunteers":196,"sex":201,"minAge":202,"maxAge":25,"enrollmentInfo":203,"targetDuration":25,"studyType":206,"phases":207,"briefSummary":209,"conditions":210,"keywords":213,"overallStatus":104,"whyStopped":25,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":229},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SoC-TAVI","ACTIVE_COMPARATOR","Pre-dilatation and post-dialation optional, as per operator preference. The balloon size used for pre- or post-dilatation is left at the operator's discretion. Operators are only encouraged to post-dilate the implanted transcatheter aortic valve (TAV) in case of ≥ moderate paravalvular regurgitation or a suboptimal transvalvular gradient.",[13],"Procedure: SoC-TAVI",{"label":15,"type":16,"description":17,"interventionNames":18},"OptEx-TAVI","EXPERIMENTAL","Systematic pre-dilatation and post-dilatation with an optimally-sized balloon",[19],"Procedure: OptEx-TAVI",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","During TAVI with either self-expanding or balloon-expandable TAVs:\n\n* Pre-dilatation: systematic pre-dilatation with an optimally-sized balloon.\n* Post-dilatation: systematic TAV post-dilatation with an optimally-sized balloon.\n\nOptimally-sized balloon:\n\n1. The recommended balloon size used for pre- and post-dilatation is the perimeter-derived mean diameter of the native aortic annulus minus 1 mm and should never exceed the perimeter-derived mean diameter of the native aortic annulus. A smaller-sized balloon should be considered in case of severe left ventricular outflow tract calcium and\u002For severely calcified leaflets in combination with a shallow sinus of Valsalva.\n2. In case of post-dilatation of the Evolut TAV (Medtronic, USA), the instructions for use (IFU) for post-dilatation of the Evolut valve should be respected.\n3. Also, a balloon-expandable TAV has to be post-dilated with an optimally-sized balloon in case of randomization to the OptEx-TAVI arm.",[15],null,{"type":22,"name":9,"description":27,"armGroupLabels":28,"otherNames":25},"During TAVI with either self-expanding or balloon-expandable TAVs: Pre-dilatation: optional, as per operator preference and post-dilatation: optional, as per operator preference. Operators are only encouraged to post-dilate the implanted TAV in case of ≥ moderate paravalvular regurgitation or a suboptimal transvalvular gradient. The balloon size used for pre- or post-dilatation is left at the operator's discretion.",[9],[30],{"name":31,"affiliation":32,"role":33},"Ole De Backer, MD, PhD, FESC","The Heart Center, Rigshospitalet","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+4535457086","ole.de.backer@regionh.dk",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Troels H Jørgensen, MD, PhD","+4535450892","troels.hoejsgaard.joergensen.01@regionh.dk",[44,61,74,89,102,114,127,142,160,175],{"facility":45,"status":46,"city":47,"state":25,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"CHU Charleroi","NOT_YET_RECRUITING","Charleroi","6000","Belgium","BE",{"type":52,"coordinates":53},"Point",[54,55],4.44448,50.41136,{"lat":55,"lon":54},[58],{"name":59,"role":36,"phone":25,"phoneExt":25,"email":60},"Adel Aminian","adel.aminian@chu-charleroi.be",{"facility":62,"status":46,"city":63,"state":25,"zip":64,"country":49,"countryCode":50,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"UZ Leuven","Leuven","3000",{"type":52,"coordinates":66},[67,68],4.70093,50.87959,{"lat":68,"lon":67},[71],{"name":72,"role":36,"phone":25,"phoneExt":25,"email":73},"Christophe Dubois, MD, PhD","christophe.dubois@uzleuven.be",{"facility":75,"status":46,"city":76,"state":25,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Skejby Hospital","Aa","8200","Denmark","DK",{"type":52,"coordinates":81},[82,83],9.97874,55.21642,{"lat":83,"lon":82},[86],{"name":87,"role":36,"phone":25,"phoneExt":25,"email":88},"Christian J Terkelsen","christian.juhl.terkelsen@clin.au.dk",{"facility":90,"status":46,"city":91,"state":25,"zip":92,"country":78,"countryCode":79,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Aalborg University Hospital","Aalborg","9000",{"type":52,"coordinates":94},[95,96],9.9187,57.048,{"lat":96,"lon":95},[99],{"name":100,"role":36,"phone":25,"phoneExt":25,"email":101},"Ashkan Eftekhari","asef@rn.dk",{"facility":103,"status":104,"city":105,"state":25,"zip":25,"country":78,"countryCode":79,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Rigshospitalet","RECRUITING","Copenhagen",{"type":52,"coordinates":107},[108,109],12.56553,55.67594,{"lat":109,"lon":108},[112,113],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},{"facility":115,"status":46,"city":116,"state":25,"zip":117,"country":78,"countryCode":79,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Odense University Hospital","Odense C","5000",{"type":52,"coordinates":119},[120,121],10.39538,55.40841,{"lat":121,"lon":120},[124],{"name":125,"role":36,"phone":25,"phoneExt":25,"email":126},"Henrik Nissen","henrik.nissen@rsyd.dk",{"facility":128,"status":46,"city":129,"state":25,"zip":130,"country":131,"countryCode":132,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Turku University Hospital","Turku","20520","Finland","FI",{"type":52,"coordinates":134},[135,136],22.26869,60.45148,{"lat":136,"lon":135},[139],{"name":140,"role":36,"phone":25,"phoneExt":25,"email":141},"Mikko Savontaus","mikko.savontaus@tyks.fi",{"facility":143,"status":46,"city":144,"state":25,"zip":145,"country":146,"countryCode":147,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"St. Antonius Hospital","Nieuwegein","3435","Netherlands","NL",{"type":52,"coordinates":149},[150,151],5.08056,52.02917,{"lat":151,"lon":150},[154,157],{"name":155,"role":36,"phone":25,"phoneExt":25,"email":156},"Jur ten Berg, MD, PhD","j.ten.berg@antoniusziekenhuis.nl",{"name":158,"role":36,"phone":25,"phoneExt":25,"email":159},"Christian Overduin, MD, PhD","c.overduin@antoniusziekenhuis.nl",{"facility":161,"status":46,"city":162,"state":25,"zip":163,"country":164,"countryCode":165,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Oslo universitetssygehus","Oslo","0450","Norway","NO",{"type":52,"coordinates":167},[168,169],10.74609,59.91273,{"lat":169,"lon":168},[172],{"name":173,"role":36,"phone":25,"phoneExt":25,"email":174},"Kristoffer Engh Russell, MD, PhD","krruss@ous-hf.no",{"facility":176,"status":46,"city":177,"state":25,"zip":178,"country":179,"countryCode":180,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Sahlgrenska University Hospital","Gothenburg","413 45","Sweden","SE",{"type":52,"coordinates":182},[183,184],11.96679,57.70716,{"lat":184,"lon":183},[187],{"name":188,"role":36,"phone":25,"phoneExt":25,"email":189},"Oskar Angerås, MD, PhD","oskar.angeras@vgregion.se",{"type":191,"investigatorFullName":192,"investigatorTitle":193,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Ole De Backer","Professor of Cardiologi, Principal investigator","100596213","optimized-expansion-of-the-implanted-transcatheter-aortic-valve-100596213",false,"NCT07042529","Optimized Expansion of the Implanted Transcatheter Aortic Valve","Optimized Expansion of the Implanted Transcatheter Aortic Valve to Reduce Hypoattenuating Leaflet Thickening in Non-atrial Fibrillation Patients Undergoing Transcatheter Aortic Valve Implantation: an International, Multicentre, Randomized Controlled Trial","Inclusion Criteria:\n\n* Severe symptomatic aortic stenosis patients with an indication for TAVI\n* Ability to understand and to comply with the study protocol\n\nExclusion Criteria:\n\n* Existing indication for oral anticoagulation (e.g., atrial fibrillation, venous thromboembolism, antiphospholipid syndrome, mechanical mitral valve)\n* Creatinine clearance \\\u003C15 mL\u002Fmin (CKD-EPI formula) or on renal replacement therapy\n* Iodine contrast allergy or other condition that prohibits cardiac CT imaging","ALL","18 Years",{"count":204,"type":205},620,"ESTIMATED","INTERVENTIONAL",[208],"NA","Optimized Expansion of the implanted transcatheter aortic valve to reduce hypoattenuating leaflet thickening in non-atrial fibrillation patients undergoing transcatheter aortic valve implantation (TAVI): an international, multicentre, randomized controlled trial.\n\nThe objective is to evaluate whether TAVI with systematic optimized pre- and post-dilatation (optimized expansion (OptEx) TAVI strategy), compared to a standard of care (SoC) TAVI strategy, is superior in reducing hypoattenuating leaflet thickening as evaluated by cardiac computed tomography (CT) imaging at three months after TAVI.\n\nThe primary outcome is at least one thickened TAV leaflet involving ≥ 25% of the leaflet curvilinear dimension as assessed at cardiac CT at three months after TAVI.",[211,212],"Aortic Stenosis Disease","Valvular Heart Disease",[214,215,216,217,218,219],"Aortic stenosis","Cardiovascular","Transcatheter aortic valve","Transcatheter aortic valve implantation","Valvular heart disease","TAVI","2026-02-01",{"date":222,"type":223},"2026-02-03","ACTUAL",{"date":225,"type":223},"2025-10-05",{"date":227,"type":205},"2033-07-01",{"name":192,"class":6},10]