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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Dronedarone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-80 years; Diagnosis of non-paroxysmal AF Undergoing AF ablation for the first time Exclusion Criteria: Unwilling to take or intolerant to dronedarone; Hypersensitivity to the drug ingredient Patients with decompensated heart failure, class NYHA IV, or left ventricular ejection fraction (LVEF) ≤40% Bradycardia <50 bpm QTc Bazett interval ≥500ms or PR interval >280ms II or III atrioventricular (AV) block or sick-sinus syndrome without permanent pacemaker Diagnosed with acute coronary syndrome or treated with percutaneous coronary intervention within the last 3 months Patients with structural heart disease (moderate to severe aortic or mitral valve stenosis, interventricular septal thickness >15mm, congenital heart disease) Accepted cardiac surgery within the last 3 months Left atrial diameter (LAD) >55 mm Patients with left atrial or left auricular thrombosis Patients with Hyperthyroidism Severe dysfunction of liver and kidney diseases (ALT≥3ULN or eGFR<30ml/min/1.73m2) Abnormal blood coagulation Concomitant use of dabigatran Concomitant use of drugs that prolong QTc or may induce torsades de pointes Concomitant use of strong CYP3A inhibitors Concomitant use of another Class IA, IC, or III AADs Patients suffering from serious infection, mental illness or malignant tumors Pregnancy or breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dronedarone<br>dronedarone 400mg twice a day for 9 months | Drug: Dronedarone<br>* oral administration fed conditions<br>|
| Placebo Comparator: placebo<br>Placebo(for dronedarone ) a day for 9 months | Drug: Placebo<br>* strictly identical in appearance with dronedarone,oral administration fed conditions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| drug withdrawal because of side effect |  | post 3 to 12 months after ablation | 
| drug withdrawal due to intolerance to or persistent AA(lasting more than 7 days) |  | post 3 to 12 months after ablation | 
| time to first recurrence |  | post 3 to 12 months after ablation | 
| cardioversion due to recurrence |  | post 3 to 12 months after ablation | 
| repeat ablation due to recurrence |  | post 3 to 12 months after ablation | 
| unscheduled visit and rehospitalization due to recurrence |  | post 3 to 12 months after ablation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dronedarone, placebo, non-paroxysmal atrial fibrillation, ablation