[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100472664":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":31,"locations":39,"responsibleParty":62,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":18,"enrollmentInfo":76,"targetDuration":18,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Population Health Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Surgical Atrial Fibrillation Ablation Group","EXPERIMENTAL","Surgeon will perform left atrial ablation during patient's cardiac surgery procedure.",[13],"Procedure: Surgical Atrial Fibrillation Ablation",{"label":15,"type":16,"description":17,"interventionNames":18},"No Surgical Atrial Fibrillation Ablation Group","NO_INTERVENTION","Surgeon will not perform left atrial ablation during the patient's cardiac surgery procedure.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","Surgical Atrial Fibrillation Ablation","Surgeon will preform surgical atrial fibrillation ablation using either cryoablation or bipolar radiofrequency clamps including 2 layers of atrium or vein, a minimum of 2 burns per clamping with at least 3 lines in the ablation group. Cavo-tricuspid isthmus and mitral lines will be allowed.",[9],[26,29],{"name":27,"affiliation":5,"role":28},"Richard Whitlock","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":5,"role":28},"Emilie Belley-Côté",[32,36],{"name":27,"role":33,"phone":34,"phoneExt":18,"email":35},"CONTACT","905-521-2100","Richard.Whitlock@phri.ca",{"name":37,"role":33,"phone":18,"phoneExt":18,"email":38},"SAFE Coordinators","SAFE@phri.ca",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Hamilton General Hospital","RECRUITING","Hamilton","Ontario","L8L 2X2","Canada","CA",{"type":49,"coordinates":50},"Point",[51,52],-79.84963,43.25011,{"lat":52,"lon":51},[55,60],{"name":56,"role":33,"phone":57,"phoneExt":58,"email":59},"Richard Whitlock, MD PhD FRCSC","905-527-4322","40306","richard.whitlock@phri.ca",{"name":61,"role":28,"phone":18,"phoneExt":18,"email":18},"Richard Whitlock, MD MSc FRCSC",{"type":28,"investigatorFullName":27,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Professor of Surgery",[65],{"name":66,"class":6},"Hamilton Health Sciences Corporation","100472664","surgical-ablation-of-af-efficacy-trial-100472664",false,"NCT05434819","Surgical Ablation of AF Efficacy Trial","SAFE","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Undergoing a clinically indicated cardiac surgical procedure: CABG, AVR, ascending aorta replacement, or combinations thereof;\n* Documented history of paroxysmal or persistent AF\n* Provide informed consent\n\nExclusion Criteria:\n\n* Dominant atrial arrhythmia is atrial flutter;\n* Documented left atrial diameter ≥ 6 cm;\n* Previous cardiac surgery requiring opening of the pericardium;\n* Patients undergoing any of the following procedures:\n\n  1. Heart transplant\n  2. Complex congenital heart surgery\n  3. Sole indication for surgery is ventricular assist device insertion\n  4. Mitral valve repair or replacement\n  5. Tricuspid valve repair or replacement\n* Patient resides in a long-term care facility","ALL","18 Years",{"count":77,"type":78},2000,"ESTIMATED","INTERVENTIONAL",[81],"NA","SAFE is an international multicentre RCT of concomitant surgical atrial fibrillation (AF) ablation in patients with paroxysmal or persistent AF undergoing cardiac surgery.",[84,85],"Atrial Fibrillation","Heart Failure",[87,88],"Surgical Ablation","Cardiac Surgery","2025-02-27",{"date":91,"type":92},"2025-03-04","ACTUAL",{"date":94,"type":92},"2023-06-01",{"date":96,"type":78},"2026-12-31",{"name":5,"class":6},1]