Dronedarone in Pacemakers Patients With Paroxysmal Atrial Fibrillation

• Status: Unknown status
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to accurately investigate the efficacy of dronedarone in maintaining sinus rhythm and decreasing AFB in patients with paroxysmal atrial fibrillation as compared with placebo. This has never previously been performed using pacemaker Holter monitoring which provides detailed information of atrial arrhythmia patterns the entire study period. Additionally detailed patient symptom self assessment and questionnaires will be collected. The study design will be double blinded crossover with each phase lasting 3 months.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastbourne General Hospital
• Treatments: Amiodarone; Dronedarone

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.

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.