Overview

Effects of Dronedarone on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers

Status:
Terminated
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
Summary
Primary objective was to evaluate the effects of dronedarone on Atrial Fibrillation (AF) burden (i.e. percent time in AF) as measured on electrogram (EGM) in subjects with a permanent pacemaker. Secondary objectives were to evaluate: - the effects of dronedarone on AF pattern characteristics i.e. ventricular rate during AF; - the effects of dronedarone on subject-perceived AF burden and symptom severity as reported by subjects using the Atrial Fibrillation Severity Scale (AFSS); - the incidence of electrical cardioversion (or overdrive pacing) during treatment; - the safety of dronedarone.
Phase:
Phase 4
Details
Lead Sponsor:
Sanofi
Treatments:
Amiodarone
Dronedarone