ATRIAL-FIBRILLATION FOLLOW-UP INVESTIGATION OF RHYTHM MANAGEMENT - THE AFFIRM STUDY DESIGN

The Atrial Fibrillation Follow-vp Investigation of Rhythm Management ( AFFIRM) Study is a randomized evaluation of treatment of atrial fibril lation by 1 of 2 strategies: ventricular rate control and anticoagulat ion versus rhythm control and anticoagulation. The primary end point i s total mortality, analyzed by intention-to-treat. Secondary end point s are composite end points (total mortality, disabling intracranial bl eed [subdural and/or subarachnoid hemorrhage], stroke [embolus, thromb osis, hemorrhage], disabling anoxic encephalopathy, cardiac arrest, ma jor noncentral nervous system bleed), cost of therapy, and quality of life, AFFIRM will randomize therapy and follow 5,300 patients for an a verage of 3.5 years (minimum 2 years) at 200 sites in the United State s and Canada. (C) 1997 by Excerpta Medica, Inc.