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

Atrial Fibrillation Clinical Trial

— DORIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05655468
• Other study ID #: DFLC2022011
• Status: Recruiting
• Phase: Phase 4
• Start date: March 29, 2023
• Est. completion date: November 2025

Study information

• Verified date: April 2023
• Source: Shanghai East Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 268
• Est. completion date: November 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrence

Intervention

Drug:
• Dronedarone
oral administration fed conditions
• Placebo
strictly identical in appearance with dronedarone,oral administration fed conditions

Locations

Country	Name	City	State
China	Shanghai East Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai East Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative nonrecurrence rate	defined as any atrial tachyarrhythmias (including atrial fibrillation, atrial flutter, or atrial tachycardia) recorded by electrocardiogram (ECG)>30s	post 3 to 12 months after ablation
Secondary	drug withdrawal because of side effect		post 3 to 12 months after ablation
Secondary	drug withdrawal due to intolerance to or persistent AA(lasting more than 7 days)		post 3 to 12 months after ablation
Secondary	time to first recurrence		post 3 to 12 months after ablation
Secondary	cardioversion due to recurrence		post 3 to 12 months after ablation
Secondary	repeat ablation due to recurrence		post 3 to 12 months after ablation
Secondary	unscheduled visit and rehospitalization due to recurrence		post 3 to 12 months after ablation