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

Phase 4

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Drug: Dronedarone; Drug: Placebo (for Dronedarone)

• Registration Number: NCT01135017
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study First Submitted: 2010-05-28
• Study First Submitted QC: 2010-05-28
• Study First Posted: 2010-06-02
• Study Start: 2010-07
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Results First Submitted: 2013-02-21
• Results First Submitted QC: 2013-02-21
• Status Verified: 2013-04
• Results First Posted: 2013-04-01
• Last Update Submitted: 2013-04-05
• Last Update Posted: 2013-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dronedarone	Dronedarone	Dronedarone 400 mg twice a day for 12 weeks
Placebo	Placebo (for Dronedarone)	Placebo (for Dronedarone) twice a day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Atrial Fibrillation (AF) Burden During the 12-week Treatment Period	Baseline (before randomization), 4 weeks and 12 weeks after randomization	AF burden, defined as the percent time a subject is in AF, was evaluated centrally by a Pacemaker Core Lab based on pacemaker interrogation reports including Electrogram (EGM) data provided by the Investigator.; AF burden during the 12-week treatment period was defined as the duration-weighted average of AF burden collected at Week 4 and Week 12. It was calculated from the single available measurement when one measurement was missing.

Secondary Outcome Measures

Name	Time	Method
AF Burden During the First 4 Weeks of Treatment and After 4-week Treatment	4 weeks and 12 weeks after randomization	AF burden at each pacemaker interrogation as evaluated centrally by the Pacemaker Core Lab
Average Ventricular Rate During AF Episodes	Baseline (before randomization), 4 weeks and 12 weeks after randomization	Ventricular rates of AF episodes were obtained from pacemaker interrogation and EGM review.; The average ventricular rate during AF episodes in the 12-week treatment period was defined as the duration-weighted average of the ventricular rates collected at Week 4 and Week 12. It was calculated from the single available measurement when one measurement was missing.
Atrial Fibrillation Severity Scale (AFSS) Scores	Baseline (before randomization) and 12 weeks after randomization	The University of Toronto Atrial Fibrillation Severity Scale is an instrument to assess the subject-perceived AF burden and AF symptom severity. It consists in a questionnaire plus a scoring algorithm.; AF Burden score ranges from 3 to 30 and higher scores indicate greater AF burden.; AF symptoms severity score ranges from 0 to 35 and higher scores indicate extremely severe AF symptoms.
Incidence Rate of Electrical Cardioversion (or Overdrive Pacing)	12 weeks	Electrical cardioversion is a procedure in which an electric shock is used to restore normal heart rhythm. Overdrive pacing is a procedure in which an artificial cardiac pacemaker is used to increase the heart rate in order to suppress certain arrhythmias.; Incidence rate of electrical cardioversion (or overdrive pacing) is expressed as the number of participants that was cardioverted or paced during the study.

Trial Locations

Locations (92)

Investigational Site Number 840015; 🇺🇸 Birmingham, Alabama, United States

Investigational Site Number 840087; 🇺🇸 Huntsville, Alabama, United States

Investigational Site Number 840018; 🇺🇸 Mobile, Alabama, United States

Investigational Site Number 840030; 🇺🇸 Mesa, Arizona, United States

Investigational Site Number 840048; 🇺🇸 Phoenix, Arizona, United States

Investigational Site Number 840072; 🇺🇸 Phoenix, Arizona, United States

Investigational Site Number 840013; 🇺🇸 Tucson, Arizona, United States

Investigational Site Number 840069; 🇺🇸 Hot Springs, Arkansas, United States

Investigational Site Number 840121; 🇺🇸 Beverly Hills, California, United States

Investigational Site Number 840090; 🇺🇸 Laguna Hills, California, United States

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