[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592291":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":28,"responsibleParty":233,"collaborators":235,"id":238,"slug":239,"hasResults":240,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":7,"eligibilityCriteria":244,"healthyVolunteers":240,"sex":245,"minAge":7,"maxAge":7,"enrollmentInfo":246,"targetDuration":7,"studyType":249,"phases":7,"briefSummary":250,"conditions":251,"keywords":253,"overallStatus":31,"whyStopped":7,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":265},{"fullName":5,"class":6},"World Health Research Inc.","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"OTHER","The ABC Bicuspid Sizing Algorithm","The ABC Bicuspid Sizing Algorithm is a valve sizing algorithm. It guides operators' evaluations of CT scans, helping inform (1) treatment allocation between TAVR and surgical aortic valve replacement, and (2) valve choice for patients undergoing TAVR. In select cases, the algorithm will suggest gated CT evaluation or artificial intelligence-based simulation models be used to further evaluate the risk of the planned valve size and deployment volume. The operators will consider the findings of the ABC Bicuspid Sizing Algorithm as well as other clinical factors when making their final treatment decisions.",[14],{"name":15,"affiliation":16,"role":17},"Tej PM Sheth, MD, FRCPC","McMaster University, World Health Research Inc.","PRINCIPAL_INVESTIGATOR",[19,24],{"name":20,"role":21,"phone":22,"phoneExt":7,"email":23},"Sarah Tawadros, MD","CONTACT","647-783-3521","sarah.tawadros@worldhealthresearch.ca",{"name":25,"role":21,"phone":26,"phoneExt":7,"email":27},"Frank Naus","416-706-2579","frank.naus@worldhealthresearch.ca",[29,43,48,58,67,77,87,99,109,119,129,138,147,157,168,180,191,203,212,222],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":7},"North Shore Private Hospital","RECRUITING","St Leonards","New South Wales","2065","Australia","AU",{"type":38,"coordinates":39},"Point",[40,41],151.19836,-33.82344,{"lat":41,"lon":40},{"facility":44,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":45,"geoPoint":47,"contacts":7},"Royal North Shore Hospital",{"type":38,"coordinates":46},[40,41],{"lat":41,"lon":40},{"facility":49,"status":31,"city":50,"state":51,"zip":52,"country":35,"countryCode":36,"cosmosGeoPoint":53,"geoPoint":57,"contacts":7},"The Prince Charles Hospital","Chermside","Queensland","4032",{"type":38,"coordinates":54},[55,56],153.03062,-27.38472,{"lat":56,"lon":55},{"facility":59,"status":31,"city":60,"state":51,"zip":61,"country":35,"countryCode":36,"cosmosGeoPoint":62,"geoPoint":66,"contacts":7},"St Andrew's War Memorial Hospital","Spring Hill","4000",{"type":38,"coordinates":63},[64,65],153.02311,-27.46141,{"lat":65,"lon":64},{"facility":68,"status":31,"city":69,"state":70,"zip":71,"country":35,"countryCode":36,"cosmosGeoPoint":72,"geoPoint":76,"contacts":7},"The Alfred","Melbourne","Victoria","3004",{"type":38,"coordinates":73},[74,75],144.96332,-37.814,{"lat":75,"lon":74},{"facility":78,"status":31,"city":79,"state":80,"zip":81,"country":35,"countryCode":36,"cosmosGeoPoint":82,"geoPoint":86,"contacts":7},"Fiona Stanley Hospital","Murdoch","Western Australia","6150",{"type":38,"coordinates":83},[84,85],115.83757,-32.06987,{"lat":85,"lon":84},{"facility":88,"status":31,"city":89,"state":90,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":98,"contacts":7},"Foothills Medical Centre","Calgary","Alberta","T2N 2T9","Canada","CA",{"type":38,"coordinates":95},[96,97],-114.08529,51.05011,{"lat":97,"lon":96},{"facility":100,"status":31,"city":101,"state":102,"zip":103,"country":92,"countryCode":93,"cosmosGeoPoint":104,"geoPoint":108,"contacts":7},"NovaScotia Health Authority- Halifax Infimary","Halifax","NovaScotia","B3H 3A7",{"type":38,"coordinates":105},[106,107],-63.57688,44.64269,{"lat":107,"lon":106},{"facility":110,"status":31,"city":111,"state":112,"zip":113,"country":92,"countryCode":93,"cosmosGeoPoint":114,"geoPoint":118,"contacts":7},"Hamilton General Hospital","Hamilton","Ontario","L8L 2X2",{"type":38,"coordinates":115},[116,117],-79.84963,43.25011,{"lat":117,"lon":116},{"facility":120,"status":121,"city":122,"state":112,"zip":123,"country":92,"countryCode":93,"cosmosGeoPoint":124,"geoPoint":128,"contacts":7},"Southlake Regional Health Centre","NOT_YET_RECRUITING","Newmarket","L3Y 2P9",{"type":38,"coordinates":125},[126,127],-79.46631,44.05011,{"lat":127,"lon":126},{"facility":130,"status":31,"city":131,"state":112,"zip":132,"country":92,"countryCode":93,"cosmosGeoPoint":133,"geoPoint":137,"contacts":7},"University of Ottawa Heart Institute","Ottawa","K1Y 4W7",{"type":38,"coordinates":134},[135,136],-75.69812,45.41117,{"lat":136,"lon":135},{"facility":139,"status":31,"city":140,"state":112,"zip":141,"country":92,"countryCode":93,"cosmosGeoPoint":142,"geoPoint":146,"contacts":7},"St. Michael's Hospital","Toronto","M5B 1W8",{"type":38,"coordinates":143},[144,145],-79.39864,43.70643,{"lat":145,"lon":144},{"facility":148,"status":31,"city":149,"state":150,"zip":151,"country":92,"countryCode":93,"cosmosGeoPoint":152,"geoPoint":156,"contacts":7},"Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval","Québec","Quebec","G1V 4G5",{"type":38,"coordinates":153},[154,155],-71.21454,46.81228,{"lat":155,"lon":154},{"facility":158,"status":31,"city":159,"state":7,"zip":160,"country":161,"countryCode":162,"cosmosGeoPoint":163,"geoPoint":167,"contacts":7},"Fundación Cardioinfantil - LaCardio","Bogotá","111011","Colombia","CO",{"type":38,"coordinates":164},[165,166],-74.08175,4.60971,{"lat":166,"lon":165},{"facility":169,"status":121,"city":170,"state":171,"zip":172,"country":173,"countryCode":174,"cosmosGeoPoint":175,"geoPoint":179,"contacts":7},"Hospital San Juan de Dios","San José","Provincia de San José","10104","Costa Rica","CR",{"type":38,"coordinates":176},[177,178],-84.08489,9.93388,{"lat":178,"lon":177},{"facility":181,"status":31,"city":182,"state":7,"zip":183,"country":184,"countryCode":185,"cosmosGeoPoint":186,"geoPoint":190,"contacts":7},"Centro Médico Nacional Siglo XXI","Mexico City","06720","Mexico","MX",{"type":38,"coordinates":187},[188,189],-99.12766,19.42847,{"lat":189,"lon":188},{"facility":192,"status":31,"city":193,"state":194,"zip":195,"country":196,"countryCode":197,"cosmosGeoPoint":198,"geoPoint":202,"contacts":7},"Wellington Regional Hospital","Newtown","Wellington Region","6021","New Zealand","NZ",{"type":38,"coordinates":199},[200,201],174.77935,-41.31115,{"lat":201,"lon":200},{"facility":204,"status":31,"city":205,"state":7,"zip":206,"country":196,"countryCode":197,"cosmosGeoPoint":207,"geoPoint":211,"contacts":7},"Christchurch Hospital","Christchurch","4710",{"type":38,"coordinates":208},[209,210],172.63333,-43.53333,{"lat":210,"lon":209},{"facility":213,"status":31,"city":214,"state":7,"zip":215,"country":214,"countryCode":216,"cosmosGeoPoint":217,"geoPoint":221,"contacts":7},"National Heart Centre Singapore","Singapore","169609","SG",{"type":38,"coordinates":218},[219,220],103.85007,1.28967,{"lat":220,"lon":219},{"facility":223,"status":121,"city":224,"state":7,"zip":225,"country":226,"countryCode":227,"cosmosGeoPoint":228,"geoPoint":232,"contacts":7},"Ramathibodi Hospital","Bangkok","10400","Thailand","TH",{"type":38,"coordinates":229},[230,231],100.50144,13.75398,{"lat":231,"lon":230},{"type":234,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[236],{"name":237,"class":6},"Edwards Lifesciences","100592291","a-study-of-transcatheter-aortic-valve-replacement-case-selection-and-valve-sizing-using-the-abc-bicuspid-sizing-algorithm-100592291",false,"NCT06991517","A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm","A Prospective Cohort Study of Bicuspid Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm for Sapien 3 Balloon Expandable Valve","Inclusion Criteria:\n\n* Have bicuspid aortic valve disease\n* Have severe aortic stenosis or mixed aortic stenosis and regurgitation requiring treatment\n* Have no other condition requiring surgical intervention\n* Have had a TAVR CT scan (retrospectively gated contrast enhanced acquisition) that is of diagnostic quality and includes multiphase reconstructions of the aortic root at the minimum available slice thickness (with at least three systolic and one diastolic phases)\n* Would be treated with a Sapien 3 valve if found to be anatomically suitable for TAVR\n* Have a suitable access route for TAVR with a Sapien 3 valve\n\nExclusion Criteria:\n\n* Are treated with TAVR using a device other than a Sapien 3 valve\n* Are unable to be treated with TAVR due to intercurrent illness, clinical instability, or death on waitlist after being accepted for TAVR\n* TAVR considered high risk and not feasible due to risk of coronary occlusion, risk of sino tubular junction (STJ) injury and severe LVOT calcification\n* Annular area less than 275 mm² or more than 750 mm²","ALL",{"count":247,"type":248},290,"ESTIMATED","OBSERVATIONAL","The goal of this study is to learn what effects the ABC Bicuspid Sizing Algorithm has on the clinical outcomes of patients with bicuspid aortic stenosis after having a transcatheter aortic valve replacement (TAVR) using the Sapien 3 valve. The main questions the study aims to answer are:\n\n1. Does the ABC Bicuspid Sizing Algorithm increase the technical success at exit from the procedure room?\n2. Does the ABC Bicuspid Sizing Algorithm increase the device success at 30 days after the procedure?\n\nParticipants already being evaluated for a TAVR as part of their regular medical care for bicuspid aortic stenosis will have their diagnostic images assessed using the ABC Bicuspid Sizing Algorithm to help determine their procedure type and valve size. They will have visits 30 days and annually till 5 years after their procedure.",[252],"Aortic Stenosis",[254,255],"Bicuspid Aortic Stenosis","Transcatheter Aortic Valve Replacement","2026-07-20",{"date":258,"type":259},"2026-07-21","ACTUAL",{"date":261,"type":259},"2025-05-13",{"date":263,"type":248},"2031-12",{"name":5,"class":6},20]