ASymptomatic atrial fibrillation and Stroke Evaluation in pacemaker patients and the atrial fibrillation Reduction atrial pacing Trial (ASSERT).

Asymptomatic atrial fibrillation (AF) is common and may have the same prognostic implications as symptomatic AF. Among patients receiving dual-chamber pacemakers, it is now possible to quantify asymptomatic AF accurately. Most of these episodes are of short duration, often lasting only seconds to minutes and are called atrial high-rate episodes (AHRE) to distinguish them from the longer episodes of overt AF. To understand properly the clinical importance of asymptomatic AF, a large study of pacemaker patients without clinically overt AF is required. ASSERT is a multicenter, cohort follow-up, and single-blinded randomized trial in elderly hypertensive patients with a pacemaker recently implanted for sinus or atrioventricular node disease. The goals of this trial are to evaluate whether the detection of AHRE with pacemaker telemetry predicts an increased risk of stroke and other vascular events and to evaluate if atrial overdrive pacing reduces symptomatic AF. ASSERT is evaluating the hypothesis that among pacemaker patients without a previous history of AF, detection of AHRE predicts an increased risk of stroke and systemic embolism. The second hypothesis to be tested is that overdrive atrial pacing will reduce the risk of symptomatic AF in pacemaker patients without a previous history of AF. Finally, a 400-patient substudy will use the noninvasive testing capabilities of the patients' pacemaker to evaluate changes in atrial electrophysiology over 2 years. This substudy will determine if atrial electrical remodeling is detectable in pacemaker patients and if it is associated with the development of AF.

RCT Entities:   Population Interventions Outcomes