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

Atrial Fibrillation Clinical Trial

Official title: A Placebo-Controlled, Double-Blind, Randomized, Multi-Center Study to Assess the Effects of Dronedarone 400 mg BID for 12 Weeks on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

• NCT number: NCT01135017
• Study type: Interventional
• Source: Sanofi
• Status: Terminated
• Phase: Phase 4
• Start date: July 2010
• Completion date: February 2012