Paroxysmal atrial fibrillation
Conditions
Interventions
Trade Name: Multaq
Product Name: Dronedarone - Multaq
Pharmaceutical Form: Tablet
Sponsors
East Sussex NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). To assess differences in patient experience of dronedarone and placebo therapies by means of questionnaires. To assess the impact of dronedarone on the participants quality of life and daily activities. Comparison of side effects and major adverse cardiac events. ;Primary end point(s): Atrial fibrillation burden as measured by permanent pacemaker. | — |
Countries
United Kingdom
Outcome results
None listed