Using Dronedarone to Reduce Atrial Fibrillation Recurrence After Ablation
Effect of Prolonged Use of Dronedarone on Recurrence in Patients With Non-paroxysmal Atrial Fibrillation After Radiofrequency Ablation
This study is testing if taking dronedarone after heart ablation can help prevent atrial fibrillation from coming back in patients.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 268 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai East Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05655468 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effect of prolonged use of dronedarone, an anti-arrhythmic drug, on the recurrence of non-paroxysmal atrial fibrillation (AF) in patients who have undergone radiofrequency ablation. In a multicenter, randomized, placebo-controlled design, eligible participants will receive dronedarone for three months post-ablation and will then be randomly assigned to either the dronedarone or placebo group for one year. The primary endpoint is the cumulative nonrecurrence rate of AF within this period, monitored through 7-day Holter ECG patches at specified intervals. Secondary endpoints include assessing side effects, time to first recurrence, and the need for repeat interventions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with a diagnosis of non-paroxysmal atrial fibrillation who are undergoing their first ablation.
Not a fit: Patients with severe heart conditions, significant bradycardia, or those intolerant to dronedarone will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new standard for post-ablation management of non-paroxysmal atrial fibrillation, potentially reducing recurrence rates and improving patient outcomes.
How similar studies have performed: While the use of anti-arrhythmic drugs post-ablation has been explored, this specific approach with dronedarone in non-paroxysmal AF patients is novel and lacks extensive prior evidence.
Eligibility criteria
Show full inclusion / exclusion 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 another Class IA, IC, or III AADs 19. Patients suffering from serious infection, mental illness or malignant tumors 20. Pregnancy or breast-feeding
Where this trial is running
Shanghai
- Shanghai East Hospital — Shanghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.