Dronedarone in pacemaker patients with paroxysmal atrial fibrillation - DROPPAF

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

INCLUSION CRITERIA
• Patients with paroxysmal atrial fibrillation (AF burden 1-50% as defined by DDDRP PPM) during the 3 months prior to induction to the study.
• Patients who have had DDDRP pacemaker implanted for a primary or secondary indication.
•Patients must be on warfarin.
•Patients must be over 18 years old.
•Patients give informed consent form prior to participating in this study.

Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Current or previous treatment with amiodarone.
•Patient is suffering with unstable angina in last 1 week.
•Patient has had a myocardial infarction within last 2 months.
•Patient is expecting or has had major cardiac surgery within last 2 months.
•Patient is participating in a conflicting study.
•Patient is mentally incapacitated and cannot consent or comply with follow-up.
•Patient has NYHA class III/ IV heart failure.
•Pregnancy.
•Patient suffers with other cardiac rhythm disorders.
•Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings).
•GFR<30mls/min.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To accurately assess, by the use of long term beat to beat pacemaker Holter monitoring, the effect of of dronedarone upon atrial fibrillation (AF) burden. ;Secondary Objective: To accurately assess the number of irregular heart beat episodes, the frequency of the episodes and average duration of normal heart rhythm (i.e. the pattern of the irregular heart rhythm).<br><br>To assess differences in patient experience of dronedarone and placebo therapies by means of questionnaires. <br><br>To assess the impact of dronedarone on the participants quality of life and daily activities. <br><br>Comparison of side effects and major adverse cardiac events.<br>;Primary end point(s): Atrial fibrillation burden as measured by permanent pacemaker.

Secondary Outcome Measures