Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (AF). In patients who develop AF during hospitalization after cardiac surgery, the hypothesis is that a strategy of rhythm control will reduce days in hospital within 60 days of the occurrence of AF compared to a strategy of rate control.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Canadian Institutes of Health Research (CIHR); National Heart, Lung, and Blood Institute (NHLBI); National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Adrenergic beta-Antagonists; Amiodarone; Calcium Channel Blockers; Digoxin

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