Effect of Prolonged Use of Dronedarone on Recurrence in Patients With Non-paroxysmal Atrial Fibrillation After Radiofrequency Ablation

• Status: Not yet recruiting
• Trial end date: 2025-11-01
• Target enrollment: 0
• Participant gender: All

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 less 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 post-blanking period within the first year after ablation.

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

Details

• Lead Sponsor: Shanghai East Hospital
• Treatments: Dronedarone

Criteria

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 nother Class IA, IC, or III AADs

19. Patients suffering from serious infection, mental illness or malignant tumors

20. Pregnancy or breast-feeding