| Registry | NCT05655468, acronym DORIS |
|---|---|
| Status | Unknown |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 268 (Estimated) |
| Sponsor | Shanghai East Hospital (Other) |
| Conditions | Atrial Fibrillation |
| Interventions | Dronedarone, Placebo (Drug) |
| Dates | start 2023-03-29, primary completion 2025-04-01 (estimated), completion 2025-11-01 (estimated), first posted 2022-12-19, last updated 2023-04-13 |
| Locations | 1 site in China |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| dronedarone | Experimental | Drug: Dronedarone | dronedarone 400mg twice a day for 9 months |
| placebo | Placebo comparator | Drug: Placebo | Placebo(for dronedarone ) a day for 9 months |
Sex: All, ages: 18 Years to 80 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Shanghai East Hospital | Shanghai | China | Recruiting |