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

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.

Timeline

Start

2010-07

Primary completion

2012-02

Completion

2012-02

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Dronedarone; p = 0.0015; Least Squares (LS) Mean difference -59.13 (95% CI -76.322 to -29.457); NCT01135017 ↗

Drugs

Indications