[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503883":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":73,"collaborators":18,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":18,"enrollmentInfo":85,"targetDuration":18,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Population Health Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Amiodarone maintenance therapy","ACTIVE_COMPARATOR","Amiodarone 200 mg daily for four weeks",[13],"Drug: Amiodarone Hydrochloride 200 MG",{"label":15,"type":16,"description":17,"interventionNames":18},"No Amiodarone maintenance therapy","NO_INTERVENTION","No ongoing Amiodarone maintenance therapy for four weeks",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Amiodarone Hydrochloride 200 MG","200 mg daily for 4 weeks",[9],[26,27],"Pacerone","Cordarone",[29],{"name":30,"affiliation":5,"role":31},"William McIntyre, MD","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},"Ingrid Copland","CONTACT","905-512-4940","start-poaf@phri.ca",[39,59],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Hamilton General Hospital","RECRUITING","Hamilton","Ontario","L8L 2X2","Canada","CA",{"type":48,"coordinates":49},"Point",[50,51],-79.84963,43.25011,{"lat":51,"lon":50},[54,57],{"name":55,"role":35,"phone":18,"phoneExt":18,"email":56},"Leah Hayward","leah.hayward@phri.ca",{"name":58,"role":31,"phone":18,"phoneExt":18,"email":18},"Emilie Belley-Cote, MD",{"facility":60,"status":41,"city":61,"state":43,"zip":62,"country":45,"countryCode":46,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"St. Michael's Hospital","Toronto","M5B 1C9",{"type":48,"coordinates":64},[65,66],-79.39864,43.70643,{"lat":66,"lon":65},[69,71],{"name":70,"role":35,"phone":18,"phoneExt":18,"email":18},"Camila Mayorga Palacios",{"name":72,"role":31,"phone":18,"phoneExt":18,"email":18},"Gianluigi Bisleri, MD",{"type":74,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100503883","phase-3-short-term-anti-arrhythmic-therapy-for-post-operative-af-in-cardiac-surgery-patients-pilot-trial-100503883",false,"NCT05841056","Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients Pilot Trial","Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients (START-POAF) Pilot Trial","START-POAF","Inclusion Criteria:\n\n1. Aged ≥18 years;\n2. Have undergone cardiac surgery including CABG, valve surgery, ascending aorta replacement, or combinations thereof within 14 days of randomization;\n3. Had new-onset POAF (or flutter), documented by 12-lead ECG or lasting ≥ 1 hour on telemetry. Patients can be in AF or sinus rhythm at the time of randomization;\n4. Expected to receive 3 g - 5 g of amiodarone loading dose post-surgery.\n5. Expected to be ready for hospital discharge within 48 h of randomization.\n\nExclusion Criteria:\n\n1. Documented preoperative history of paroxysmal, persistent or permanent AF;\n2. Planned use of a class I or III anti-arrhythmic drug (other than study drug);\n3. Patients who have undergone heart transplant, complex congenital heart surgery, isolated ventricular assist device insertion, or AF ablation (surgical or catheter);\n4. Known allergy to ECG adhesives;\n5. Contraindication to amiodarone (i.e. hyperthyroidism, severe restrictive or obstructive lung disease, Long QT syndrome, PR \\> 240 ms, high-grade AV block).\n6. Individuals who are pregnant, breastfeeding, or of childbearing potential - female subjects, premenopausal who are not surgically sterile, or, if sexually active not practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, who have a positive pregnancy test at screening","ALL","18 Years",{"count":86,"type":87},400,"ESTIMATED","INTERVENTIONAL",[90],"PHASE3","The START-POAF pilot study is a prospective, open-label two-arm, randomized controlled trial with blinded assessment of outcomes (PROBE). This pilot study will assess Atrial Fibrillation (AF) recurrence and burden in patients with new-onset AF following cardiac surgery.",[93],"Atrial Fibrillation New Onset",[95,96,97],"cardiac surgery","heart rhythm monitoring","amiodarone","2026-05-22",{"date":100,"type":101},"2026-05-27","ACTUAL",{"date":103,"type":101},"2024-06-13",{"date":105,"type":87},"2028-11-30",{"name":5,"class":6},2]