Cardiovascular disease/cardiac arrhythmias Circulatory System Atrial fibrillation and flutter
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged greater than or equal to 18 years, either sex 2. Written informed consent 3. Non-valvular paroxysmal or persistent AF in whom a rhythm control strategy is planned 4. Duration of at least one symptomatic AF episode greater than 10 minutes within the past 6 months 5. Electrocardiogram (ECG) documentation of AF 6. Left ventricular (LV) ejection fraction greater than 40% 7. Normal thyroid stimulating hormone (TSH)
Exclusion criteria
Exclusion criteria: 1. Chronic AF (continuously present for greater than 3 months) 2. Myocardial infarction within the past month prior to selection visit 3. Cardiac or thoracic surgery within the past 3 months or likely to be performed during trial 4. Moderate to severe congestive heart failure (New York Heart Association Functional Class [NHYA FC] III - IV) 5. Left ventricular dysfunction (ejection fraction [EF] less than 40%) 6. Mitral stenosis 7. Moderate to severe mitral insufficiency (Grade 3 - 4/4) 8. AF secondary to an acute reversible condition (untreated or uncontrolled hyperthyroidism, post-operative AF, fever, anaemia) 9. Need for anti-arrhythmic therapy for a condition other than atrial fibrillation 10. Wolff-Parkinson-White syndrome 11. Any medical condition making compliance with study treatment unlikely 12. Current use of n-3 fatty acid supplements or use within the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first relapse of atrial fibrillation measured from 0 to 6 months minimum, up to 16 months if no AF recurrence between 6 - 16 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. High-sensitivity C-reactive protein levels measured at 0 and 6 months 2. Serum myeloperoxidase levels measured at 0 and 6 months | — |
Countries
Canada