Atrial Fibrillation Follow-Up Investigation of Rhythm Management—The AFFIRM Study Design

The Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Study is a randomized evaluation of treatment of atrial fibrillation by 1 of 2 strategies: ventricular rate control and anticoagulation versus rhythm control and anticoagulation. The primary end point is total mortality, analyzed by intention-to-treat. Secondary end points are composite end points (total mortality, disabling intracranial bleed [subdural and/or subarachnoid hemorrhage], stroke [embolus, thrombosis, hemorrhage], disabling anoxic encephalopathy, cardiac arrest, major noncentral nervous system bleed), cost of therapy, and quality of life. AFFIRM will randomize therapy and follow 5,300 patients for an average of 3.5 years (minimum 2 years) at 200 sites in the United States and Canada. FIRM Study is a randomized evaluation of treatment of atrial fibrillation by 1 of 2 strategies: rate control and anticoagulation versus rhythm control and anticoagulation. AFFIRM will randomize therapy and follow 5,300 patients for an average of 3.5 years at 200 sites in the United States and Canada.