Conditions: Atrial Fibrillation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 112
Healthy volunteers: no

Brief 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.

Detailed description:
The maximum duration of the study period for a participant was 18 weeks (approximatively 4.5 months) including up to 4 weeks screening, 12-week Treatment period and a post-treatment follow-up of 2 weeks.

Arms:
arm 1: Dronedarone 400 mg twice a day for 12 weeks arm 2: Placebo (for Dronedarone) twice a day for 12 weeks

Interventions: intervention 1: Dronedarone intervention 2: Placebo (for Dronedarone)
Intervention descriptions: intervention 1: Film-coated tablet

Oral administration under fed conditions (during breakfast and dinner) intervention 2: Film-coated tablet strictly identical in appearance

Oral administration under fed conditions (during breakfast and dinner)

Protocol document: