Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients Pilot Trial (START-POAF)
Atrial Fibrillation New Onset
About this trial
This is an interventional treatment trial for Atrial Fibrillation New Onset focused on measuring cardiac surgery, heart rhythm monitoring, amiodarone
Eligibility Criteria
Inclusion Criteria: Aged ≥18 years; Have undergone cardiac surgery including CABG, valve surgery, ascending aorta replacement, or combinations thereof within 14 days of randomization; 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; Expected to receive 3 g - 5 g of amiodarone loading dose post-surgery. Expected to be ready for hospital discharge within 48 h of randomization. Exclusion Criteria: Documented preoperative history of paroxysmal, persistent or permanent AF; Planned use of a class I or III anti-arrhythmic drug (other than study drug); Patients who have undergone heart transplant, complex congenital heart surgery, isolated ventricular assist device insertion, or AF ablation (surgical or catheter); Known allergy to ECG adhesives; Contraindication to amiodarone (i.e. hyperthyroidism, severe restrictive or obstructive lung disease, Long QT syndrome, PR > 240 ms, high-grade AV block). 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
Amiodarone maintenance therapy
No Amiodarone maintenance therapy
Amiodarone 200 mg daily for four weeks
No ongoing Amiodarone maintenance therapy for four weeks