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

Launched by SHANGHAI EAST HOSPITAL · Dec 16, 2022

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ClinConnect Summary

This clinical trial is studying the effects of a medication called dronedarone on patients with a heart condition known as non-paroxysmal atrial fibrillation (AF) after they undergo a procedure called radiofrequency ablation. Atrial fibrillation can cause an irregular heartbeat, and while radiofrequency ablation can help, many patients still experience a return of the condition afterward. Researchers want to see if taking dronedarone for a longer period after the procedure can help prevent this recurrence and keep the heart in a normal rhythm.

To participate in this trial, you need to be between 18 and 80 years old and have been diagnosed with non-paroxysmal atrial fibrillation. You should also be undergoing your first ablation treatment for this condition. Participants will take dronedarone and will be monitored to see how well it works in maintaining a normal heartbeat. It's important to note that there are specific health conditions that may prevent someone from joining the study, such as severe heart failure or certain heart rhythm issues. If you're interested or think you might qualify, it’s best to discuss it with your healthcare provider for more information.

Gender

ALL

Eligibility 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