[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578954":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":70,"collaborators":24,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":24,"enrollmentInfo":82,"targetDuration":24,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":96,"whyStopped":24,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of Alberta","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Arm","ACTIVE_COMPARATOR","EXPERIMENTAL ARM: TAVI WITHOUT ON-SITE SURGERY After randomization, the participant will be scheduled to undergo TAVI by experienced operators with appropriately trained cardiac catheterization staff.",[13],"Procedure: Transcatheter Aortic Valve Replacement (TAVR) without surgical oversight",{"label":15,"type":10,"description":16,"interventionNames":17},"Control Arms","CONTROL ARM: TAVI WITH ON-SITE SURGERY After randomization, the patient will be scheduled to undergo TAVI by experienced operators with appropriately trained cardiac catheterization staff at an established TAVI center with on-site cardiac surgery",[18],"Procedure: Transcatheter Aortic Valve Replacement (TAVR) with surgical oversight",[20,25],{"type":21,"name":22,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Transcatheter Aortic Valve Replacement (TAVR) with surgical oversight",[15],null,{"type":21,"name":26,"description":26,"armGroupLabels":27,"otherNames":24},"Transcatheter Aortic Valve Replacement (TAVR) without surgical oversight",[9],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Dr. Robert Welsh C Welsh, MD","CONTACT","780 407 2685","Robert.Welsh@albertahealthservices.ca",[35,56],{"facility":36,"status":24,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Royal Alexandra Hospital","Edmonton","Alberta","T5H 3V9","Canada","CA",{"type":43,"coordinates":44},"Point",[45,46],-113.46871,53.55014,{"lat":46,"lon":45},[49,53],{"name":50,"role":31,"phone":51,"phoneExt":24,"email":52},"Ben Dr. Tyrrell, MD","780 906 7704","Ben.tyrrell@albertahealthservices.ca",{"name":54,"role":55,"phone":24,"phoneExt":24,"email":24},"Ben Tyrrell, MD","PRINCIPAL_INVESTIGATOR",{"facility":57,"status":24,"city":37,"state":38,"zip":58,"country":40,"countryCode":41,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"Mazankowski Heart Insitute","T6G 2B7",{"type":43,"coordinates":60},[45,46],{"lat":46,"lon":45},[63,65,66,68],{"name":64,"role":31,"phone":32,"phoneExt":24,"email":33},"Robert C Dr. Welsh, MD",{"name":24,"role":31,"phone":24,"phoneExt":24,"email":33},{"name":67,"role":55,"phone":24,"phoneExt":24,"email":24},"Robert C Welsh, MD",{"name":54,"role":69,"phone":24,"phoneExt":24,"email":24},"SUB_INVESTIGATOR",{"type":71,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100578954","phase-4-application-of-tavi-at-experienced-interventional-cardiac-centers-without-on-site-cardiac-surgery-atlas-study-100578954",false,"NCT06818006","Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)","Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery","ATLAS","Inclusion Criteria:\n\n* Severe symptomatic AS reviewed and accepted for Transfemoral (TF) TAVI by an established Heart Team\n* Obtained informed consent\n\nExclusion Criteria:\n\n* Ambiguous aortic annular sizing on CT measurement deemed to increase the risk of valve embolization\n* Hostile aortic root on CT for TAVI implantation defined by, but not limited to:\n* High risk LVOT with a dimension significantly smaller than the annulus and\u002For extensive calcification\n* Features that increase the risk of coronary artery occlusion including inadequate coronary artery height and\u002For shallow coronary sinuses in the setting of a significant coronary artery territory at risk (accounting for prior CABG)\n* High risk STJ anatomy defined by inadequate height and\u002For diameter and\u002For excessive calcification\n* Vascular anatomy with increased risk of ascending aorta trauma (i.e. combinations of existing ascending aortic aneurysm, and\u002For unfolded aorta and\u002For extensive tortuosity and\u002For excessive iliofemoral calcification)\n* GFR \\\u003C15, excluding patients on dialysis\n* Life expectancy less than 3 years\n* Any factor precluding 1-year follow-up","ALL","18 Years",{"count":83,"type":84},600,"ESTIMATED","INTERVENTIONAL",[87],"PHASE4","The purpose of this study is to see if having the Transcatheter Aortic Valve Replacement (TAVR) procedure done in a hospital with onsite cardiac surgery available or not, makes a difference on participant outcomes. Current standard of care is to have this procedure done in a hospital with onsite cardiac surgery available.\n\nHypothesis\n\nThe investigators hypothesize that the TAVR in experienced interventional cardiac centers without on-site cardiac surgery will be safe and effective. Although this is happening clinically in select regions internationally, this change in the clinical application of TAVI requires a rigorous assessment of safety with a robust randomized trial and multicenter international collaboration.",[90,91],"Aortic Stenosis","Severe Aortic Stenosis",[90,93,94,95],"TAVR","TAVI","Sever aortic stenosis","NOT_YET_RECRUITING","2026-06-01",{"date":99,"type":100},"2026-06-02","ACTUAL",{"date":102,"type":84},"2026-08-01",{"date":104,"type":84},"2030-12",{"name":5,"class":6},2]