[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592291":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":47,"studyPopulation":48,"armGroups":20,"interventions":49,"overallOfficials":54,"centralContacts":59,"locations":69,"responsibleParty":274,"collaborators":276,"id":279,"slug":280,"hasResults":281,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":20,"eligibilityCriteria":285,"healthyVolunteers":281,"sex":286,"minAge":20,"maxAge":20,"enrollmentInfo":287,"targetDuration":20,"studyType":290,"phases":20,"briefSummary":291,"conditions":292,"keywords":294,"overallStatus":72,"whyStopped":20,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":306},{"fullName":5,"class":6},"World Health Research Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of cases achieving technical success","Freedom from mortality, successful access, delivery of the device, and retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location, and freedom from surgery or intervention related to the device or cardiac structural complication","At exit from procedure room after procedure completion",[14,18,22,25,27,29,31,34,36,39,41],{"measure":15,"description":16,"timeFrame":17},"Proportion of cases achieving device success","Technical success and intended performance of the valve (mean gradient less than 20 mmHg, peak velocity less than 3 m\u002Fs, Doppler velocity index greater than 0.35, and less than moderate aortic regurgitation)","At 30 days after the procedure",{"measure":19,"description":20,"timeFrame":21},"Proportion of cases in which the use of gated computed tomography evaluation or artificial intelligence-based simulation models altered the treatment plan or operator confidence in the treatment plan compared to the ABC Bicuspid Sizing Algorithm alone",null,"At baseline",{"measure":23,"description":20,"timeFrame":24},"New conduction disturbance and permanent pacemaker implantation","At 30 days and 1,3 and 5 years after the procedure",{"measure":26,"description":20,"timeFrame":24},"Stroke or transient ischemic attack",{"measure":28,"description":20,"timeFrame":17},"Major vascular complication",{"measure":30,"description":20,"timeFrame":24},"Death",{"measure":32,"description":20,"timeFrame":33},"Acute valve complication","Perioperative\u002FPeriprocedural",{"measure":35,"description":20,"timeFrame":24},"Need for cardiac surgery",{"measure":37,"description":20,"timeFrame":38},"Delayed valve dysfunction","At 30 days ,1,3 and 5 years after the procedure",{"measure":40,"description":20,"timeFrame":21},"Proportion of cases in which evaluation of anatomy above or below the annulus altered the valve sizing and deployment decision compared to the calculated valve sizing and deployment decision considering the annulus size only",{"measure":42,"description":20,"timeFrame":43},"Hospitalization for acute heart failure","1,3 and 5 years after the procedure",{"allocation":20,"interventionModel":20,"interventionModelDescription":20,"primaryPurpose":20,"observationalModel":45,"timePerspective":46,"maskingInfo":20},"COHORT","PROSPECTIVE","This is a multi-centre, international, prospective cohort study. Approximately 290 patients who are clinically eligible for transcatheter aortic valve replacement (TAVR) will be enrolled. Using information collected with the ABC Bicuspid Sizing Algorithm, physicians will make a treatment allocation between TAVR and surgical aortic valve replacement (SAVR), and determine valve sizing and deployment for TAVR-treated patients. Included in the algorithm use is the utilization of gated computed tomography evaluation or artificial intelligence-based simulation models in select cases with borderline feasibility. The findings of these additional assessments will be shared with the treating physicians for consideration in the final treatment decision.\n\nOf the 290 patients, an estimated 230 will be recommended to have TAVR. Data will be collected from TAVR-treated patients at baseline, procedure, hospital discharge, and 30 days and annually till 5 years after the procedure. Data will only be collected from SAVR-treated patients at baseline and procedure. Sites in Canada, Latin America, the Middle East, and Asia Pacific will participate.","Patients referred to the TAVR program at select hospitals",[50],{"type":51,"name":52,"description":53,"armGroupLabels":20,"otherNames":20},"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.",[55],{"name":56,"affiliation":57,"role":58},"Tej PM Sheth, MD, FRCPC","McMaster University, World Health Research Inc.","PRINCIPAL_INVESTIGATOR",[60,65],{"name":61,"role":62,"phone":63,"phoneExt":20,"email":64},"Sarah Tawadros, MD","CONTACT","647-783-3521","sarah.tawadros@worldhealthresearch.ca",{"name":66,"role":62,"phone":67,"phoneExt":20,"email":68},"Frank Naus","416-706-2579","frank.naus@worldhealthresearch.ca",[70,84,89,99,108,118,128,140,150,160,170,179,188,198,209,221,232,244,253,263],{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":20},"North Shore Private Hospital","RECRUITING","St Leonards","New South Wales","2065","Australia","AU",{"type":79,"coordinates":80},"Point",[81,82],151.19836,-33.82344,{"lat":82,"lon":81},{"facility":85,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":86,"geoPoint":88,"contacts":20},"Royal North Shore Hospital",{"type":79,"coordinates":87},[81,82],{"lat":82,"lon":81},{"facility":90,"status":72,"city":91,"state":92,"zip":93,"country":76,"countryCode":77,"cosmosGeoPoint":94,"geoPoint":98,"contacts":20},"The Prince Charles Hospital","Chermside","Queensland","4032",{"type":79,"coordinates":95},[96,97],153.03062,-27.38472,{"lat":97,"lon":96},{"facility":100,"status":72,"city":101,"state":92,"zip":102,"country":76,"countryCode":77,"cosmosGeoPoint":103,"geoPoint":107,"contacts":20},"St Andrew's War Memorial Hospital","Spring Hill","4000",{"type":79,"coordinates":104},[105,106],153.02311,-27.46141,{"lat":106,"lon":105},{"facility":109,"status":72,"city":110,"state":111,"zip":112,"country":76,"countryCode":77,"cosmosGeoPoint":113,"geoPoint":117,"contacts":20},"The Alfred","Melbourne","Victoria","3004",{"type":79,"coordinates":114},[115,116],144.96332,-37.814,{"lat":116,"lon":115},{"facility":119,"status":72,"city":120,"state":121,"zip":122,"country":76,"countryCode":77,"cosmosGeoPoint":123,"geoPoint":127,"contacts":20},"Fiona Stanley Hospital","Murdoch","Western Australia","6150",{"type":79,"coordinates":124},[125,126],115.83757,-32.06987,{"lat":126,"lon":125},{"facility":129,"status":72,"city":130,"state":131,"zip":132,"country":133,"countryCode":134,"cosmosGeoPoint":135,"geoPoint":139,"contacts":20},"Foothills Medical Centre","Calgary","Alberta","T2N 2T9","Canada","CA",{"type":79,"coordinates":136},[137,138],-114.08529,51.05011,{"lat":138,"lon":137},{"facility":141,"status":72,"city":142,"state":143,"zip":144,"country":133,"countryCode":134,"cosmosGeoPoint":145,"geoPoint":149,"contacts":20},"NovaScotia Health Authority- Halifax Infimary","Halifax","NovaScotia","B3H 3A7",{"type":79,"coordinates":146},[147,148],-63.57688,44.64269,{"lat":148,"lon":147},{"facility":151,"status":72,"city":152,"state":153,"zip":154,"country":133,"countryCode":134,"cosmosGeoPoint":155,"geoPoint":159,"contacts":20},"Hamilton General Hospital","Hamilton","Ontario","L8L 2X2",{"type":79,"coordinates":156},[157,158],-79.84963,43.25011,{"lat":158,"lon":157},{"facility":161,"status":162,"city":163,"state":153,"zip":164,"country":133,"countryCode":134,"cosmosGeoPoint":165,"geoPoint":169,"contacts":20},"Southlake Regional Health Centre","NOT_YET_RECRUITING","Newmarket","L3Y 2P9",{"type":79,"coordinates":166},[167,168],-79.46631,44.05011,{"lat":168,"lon":167},{"facility":171,"status":72,"city":172,"state":153,"zip":173,"country":133,"countryCode":134,"cosmosGeoPoint":174,"geoPoint":178,"contacts":20},"University of Ottawa Heart Institute","Ottawa","K1Y 4W7",{"type":79,"coordinates":175},[176,177],-75.69812,45.41117,{"lat":177,"lon":176},{"facility":180,"status":72,"city":181,"state":153,"zip":182,"country":133,"countryCode":134,"cosmosGeoPoint":183,"geoPoint":187,"contacts":20},"St. Michael's Hospital","Toronto","M5B 1W8",{"type":79,"coordinates":184},[185,186],-79.39864,43.70643,{"lat":186,"lon":185},{"facility":189,"status":72,"city":190,"state":191,"zip":192,"country":133,"countryCode":134,"cosmosGeoPoint":193,"geoPoint":197,"contacts":20},"Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval","Québec","Quebec","G1V 4G5",{"type":79,"coordinates":194},[195,196],-71.21454,46.81228,{"lat":196,"lon":195},{"facility":199,"status":72,"city":200,"state":20,"zip":201,"country":202,"countryCode":203,"cosmosGeoPoint":204,"geoPoint":208,"contacts":20},"Fundación Cardioinfantil - LaCardio","Bogotá","111011","Colombia","CO",{"type":79,"coordinates":205},[206,207],-74.08175,4.60971,{"lat":207,"lon":206},{"facility":210,"status":162,"city":211,"state":212,"zip":213,"country":214,"countryCode":215,"cosmosGeoPoint":216,"geoPoint":220,"contacts":20},"Hospital San Juan de Dios","San José","Provincia de San José","10104","Costa Rica","CR",{"type":79,"coordinates":217},[218,219],-84.08489,9.93388,{"lat":219,"lon":218},{"facility":222,"status":72,"city":223,"state":20,"zip":224,"country":225,"countryCode":226,"cosmosGeoPoint":227,"geoPoint":231,"contacts":20},"Centro Médico Nacional Siglo XXI","Mexico City","06720","Mexico","MX",{"type":79,"coordinates":228},[229,230],-99.12766,19.42847,{"lat":230,"lon":229},{"facility":233,"status":72,"city":234,"state":235,"zip":236,"country":237,"countryCode":238,"cosmosGeoPoint":239,"geoPoint":243,"contacts":20},"Wellington Regional Hospital","Newtown","Wellington Region","6021","New Zealand","NZ",{"type":79,"coordinates":240},[241,242],174.77935,-41.31115,{"lat":242,"lon":241},{"facility":245,"status":72,"city":246,"state":20,"zip":247,"country":237,"countryCode":238,"cosmosGeoPoint":248,"geoPoint":252,"contacts":20},"Christchurch Hospital","Christchurch","4710",{"type":79,"coordinates":249},[250,251],172.63333,-43.53333,{"lat":251,"lon":250},{"facility":254,"status":72,"city":255,"state":20,"zip":256,"country":255,"countryCode":257,"cosmosGeoPoint":258,"geoPoint":262,"contacts":20},"National Heart Centre Singapore","Singapore","169609","SG",{"type":79,"coordinates":259},[260,261],103.85007,1.28967,{"lat":261,"lon":260},{"facility":264,"status":162,"city":265,"state":20,"zip":266,"country":267,"countryCode":268,"cosmosGeoPoint":269,"geoPoint":273,"contacts":20},"Ramathibodi Hospital","Bangkok","10400","Thailand","TH",{"type":79,"coordinates":270},[271,272],100.50144,13.75398,{"lat":272,"lon":271},{"type":275,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[277],{"name":278,"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":288,"type":289},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.",[293],"Aortic Stenosis",[295,296],"Bicuspid Aortic Stenosis","Transcatheter Aortic Valve Replacement","2026-07-20",{"date":299,"type":300},"2026-07-21","ACTUAL",{"date":302,"type":300},"2025-05-13",{"date":304,"type":289},"2031-12",{"name":5,"class":6},20]