Effect of Prolonged Use of Dronedarone on Recurrence in Patients With Non-paroxysmal Atrial Fibrillation After Radiofrequency Ablation
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- cumulative nonrecurrence rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-80 years;
- •Diagnosis of non-paroxysmal AF
- •Undergoing AF ablation for the first time
排除标准
- •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
研究组 & 干预措施
dronedarone
dronedarone 400mg twice a day for 9 months
干预措施: Dronedarone (Drug)
placebo
Placebo(for dronedarone ) a day for 9 months
干预措施: Placebo (Drug)
结局指标
主要结局
cumulative nonrecurrence rate
时间窗: post 3 to 12 months after ablation
defined as any atrial tachyarrhythmias (including atrial fibrillation, atrial flutter, or atrial tachycardia) recorded by electrocardiogram (ECG)\>30s
次要结局
- drug withdrawal due to intolerance to or persistent AA(lasting more than 7 days)(post 3 to 12 months after ablation)
- cardioversion due to recurrence(post 3 to 12 months after ablation)
- drug withdrawal because of side effect(post 3 to 12 months after ablation)
- time to first 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)
研究者
Yang Bing
deputy director of cardiovascular department
Shanghai East Hospital