Atrial Fibrillation
Conditions
Keywords
dronedarone, placebo, non-paroxysmal atrial fibrillation, ablation
Brief summary
Recurrence rate remains high after radiofrequency ablation in patients with non-paroxysmal atrial fibrillation(AF). Prolonged use of anti-arrhythmic drugs (AAD) beyond the post-ablation blanking has been adopted as a solution but without sufficient clinical evidence. Dronedarone is an AAD valid to maintain sinus rhythm and has fewer side effect than other AAD for long-term use.We sought to investigate the effect of prolonged use of dronedarone on recurrence of non-paroxysmal AF patients beyond the post-blanking period within the first year after ablation.
Detailed description
In this multicenter, randomized, placebo-controlled trial, patients with non-paroxysmal AF will receive dronedarone for three months after radiofrequency ablation. Eligible Patients will then be randomly divided into dronedarone and placebo groups and followed up until one year after ablation. The primary endpoint is the cumulative nonrecurrence rate post three months and within one year after ablation. 7-day Holter monitoring (ECG patch) will be scheduled at 6,9, and 12 months after ablation for evaluating AA recurrence. Secondary endpoints include dronedarone withdrawal due to side effect or intolerance of AA recurrence, time to the first recurrence, repeat ablation, electrical cardioversion, unscheduled visit ,and rehospitalization. This trial will evaluate whether prolonged use of dronedarone effectively reduces recurrence rate after ablation in non-paroxysmal AF patients. The result of this trial will provide evidence for optimizing post-ablation anti-arrhythmic therapy.
Interventions
DRUGDronedarone
oral administration fed conditions
DRUGPlacebo
strictly identical in appearance with dronedarone,oral administration fed conditions
Sponsors
Shanghai East Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-80 years; 2. Diagnosis of non-paroxysmal AF 3. Undergoing AF ablation for the first time
Exclusion criteria
1. Unwilling to take or intolerant to dronedarone; 2. Hypersensitivity to the drug ingredient 3. Patients with decompensated heart failure, class NYHA IV, or left ventricular ejection fraction (LVEF) ≤40% 4. Bradycardia \<50 bpm 5. QTc Bazett interval ≥500ms or PR interval \>280ms 6. II or III atrioventricular (AV) block or sick-sinus syndrome without permanent pacemaker 7. Diagnosed with acute coronary syndrome or treated with percutaneous coronary intervention within the last 3 months 8. Patients with structural heart disease (moderate to severe aortic or mitral valve stenosis, interventricular septal thickness \>15mm, congenital heart disease) 9. Accepted cardiac surgery within the last 3 months 10. Left atrial diameter (LAD) \>55 mm 11. Patients with left atrial or left auricular thrombosis 12. Patients with Hyperthyroidism 13. Severe dysfunction of liver and kidney diseases (ALT≥3ULN or eGFR\<30ml/min/1.73m2) 14. Abnormal blood coagulation 15. Concomitant use of dabigatran 16. Concomitant use of drugs that prolong QTc or may induce torsades de pointes 17. Concomitant use of strong CYP3A inhibitors 18. Concomitant use of another Class IA, IC, or III AADs 19. Patients suffering from serious infection, mental illness or malignant tumors 20. Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cumulative nonrecurrence rate | post 3 to 12 months after ablation | defined as any atrial tachyarrhythmias (including atrial fibrillation, atrial flutter, or atrial tachycardia) recorded by electrocardiogram (ECG)\>30s |
Secondary
| Measure | Time frame |
|---|---|
| drug withdrawal due to intolerance to or persistent AA(lasting more than 7 days) | post 3 to 12 months after ablation |
| time to first recurrence | post 3 to 12 months after ablation |
| drug withdrawal because of side effect | post 3 to 12 months after ablation |
| repeat ablation due to recurrence | post 3 to 12 months after ablation |
| unscheduled visit and rehospitalization due to recurrence | post 3 to 12 months after ablation |
| cardioversion due to recurrence | post 3 to 12 months after ablation |
Countries
China
Outcome results
None listed