Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
Postoperative Atrial Fibrillation
About this trial
This is an interventional treatment trial for Postoperative Atrial Fibrillation focused on measuring Heart surgery, Cardiac surgery, Coronary artery bypass, Mitral valve surgery, Aortic valve surgery, Atrial fibrillation, Atrial flutter, Cardiac arrhythmia, Valve surgery
Eligibility Criteria
Enrollment Inclusion Criteria:
- Age > 18 years
- Undergoing heart surgery for coronary artery bypass (on-pump or off-pump CABG) and/or valve repair or replacement (excluding mechanical valves), including re-operations
- Hemodynamically stable
Randomization Inclusion Criteria
- AF that persists for > 60 minutes or recurrent (more than one) episodes of AF up to 7 days after surgery during the index hospitalization.
Exclusion Criteria:
- LVAD insertion or heart transplantation
- Maze procedure
- TAVR
- History of or planned mechanical valve replacement
- Correction of complex congenital cardiac defect (excluding bicuspid aortic valve, atrial septal defect or PFO)
- History of AF or AFL
- History of AF or AFL ablation
- Contraindications to warfarin or amiodarone
- Need for long-term anticoagulation
- Concurrent participation in an interventional (drug or device) trial
Sites / Locations
- University of Southern California
- Emory University
- University of Maryland
- NIH Heart Center at Suburban Hospital
- University of Michigan Health Services
- Montefiore Einstein Heart Center
- Icahn School of Medicine at Mount Sinai
- Columbia University Medical Center
- Mission Hospital
- Duke University
- Cleveland Clinic Foundation
- The Ohio State University Medical Center
- University of Pennsylvania
- Baylor College of Medicine
- Baylor Research Institute
- University of Virginia Health Systems
- University of Wisconsin
- University of Alberta Hospital
- Toronto General Hospital
- Centre Hospitalier de l'Université de Montréal
- Hôpital du Sacré-Cœur de Montréal
- Montreal Heart Institute
- Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Rhythm control
Rate control
Rhythm Control in post-operative AF Amiodarone and/or DC-cardioversion Amiodarone Initial Dose Oral: 400 mg po TID for 3 days is recommended For patients incapable of taking oral: 150 mg IV bolus over 10 min, then 1 mg/min over 6 hours followed by 0.5 mg/min over 18 hours Maintenance Dose Oral: at least 200 mg/day to be continued until 60 days after randomization If drug cannot be given orally or via NG tube: 0.5 mg/min administered through central line (e.g., PICC) until oral dosing is started DC-Cardioversion - frequency and duration determined by medical professional as medically needed
Rate Control in post-operative AF Beta-blocker and/or Calcium channel blockers and/or Digoxin Dose, frequency and duration determined by medical professional as medically needed