The Efficacy and Safety of Intravenous + Oral Vs. Oral Amiodarone in Preventing Recurrence After Catheter Ablation in Patients with Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 418
- 试验地点
- 1
- 主要终点
- Recurrence of atrial arrhythmia lasting more than 30 seconds.
研究概览
简要总结
This study aims to investigate the efficacy and safety of intravenous combined with oral amiodarone in preventing atrial fibrillation (AF) recurrence after catheter ablation in patients with persistent atrial fibrillation. Using a randomized controlled trial design, patients will be divided into two groups: intravenous + oral amiodarone and oral amiodarone alone. Through multiple follow-ups at 1, 3, 6, and 12 months post-procedure, the study will compare the two treatment regimens in terms of blood concentrations of amiodarone and its metabolites, efficacy (short-term recurrence [SR], long-term recurrence [LR], and patient quality of life), and safety (adverse drug reactions). Subgroup analyses will also be conducted to explore potential differences in drug treatment effects among populations with varying risk factors. This study aims to provide valuable clinical data for post-ablation management of atrial fibrillation, contributing to the development of optimized treatment strategies to enhance therapeutic outcomes and improve patient quality of life.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged ≥18 years;
- •First-time catheter ablation for persistent atrial fibrillation (defined as any - previous episode lasting ≥7 days);
- •Symptomatic atrial fibrillation patients who have failed or are intolerant to at least one class I or III antiarrhythmic drug;
- •Participants who are able to understand the purpose of the study, voluntarily agree to participate, and provide written informed consent.
排除标准
- •Those unwilling or unsuitable to restart or continue antiarrhythmic drug therapy;
- •Life expectancy < 12 months;
- •Severe liver or kidney dysfunction;
- •Allergy to amiodarone components;
- •Pregnant or breastfeeding women;
- •Contraindications to amiodarone (e.g., blood pressure < 90/60 mmHg; bradycardia < 55 bpm, second- or third-degree AV block, or sick sinus syndrome);
- •Thyroid disorders, such as hyperthyroidism or hypothyroidism.
研究组 & 干预措施
Experimental group (Intravenous + Oral Amiodarone)
Within 24 hours post-operation, patients will receive an intravenous amiodarone loading dose of 300 mg QD along with oral amiodarone 200 mg BID. This regimen will be continued for 3 days, after which intravenous amiodarone will be discontinued, and oral amiodarone 200 mg BID will be continued for 3 months.
干预措施: Amiodarone Injection (Drug)
Control group (Oral Amiodarone only)
Postoperatively, instead of administering intravenous amiodarone, sodium chloride injection was used as a placebo, and oral amiodarone 200 mg BID was directly given for 3 months.
干预措施: Sodium Chloride Injection 0.9% (Drug)
结局指标
主要结局
Recurrence of atrial arrhythmia lasting more than 30 seconds.
时间窗: At least 12 months of follow-up, beyond the initial 3 month blanking period
After a single ablation procedure, with at least 12 months of follow-up, any atrial arrhythmia recorded for more than 30 seconds - including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - occurring beyond the initial 3-month blanking period.
次要结局
- hospital readmission for re-ablation, electrical cardioversion and adverse drug events (ADEs)(At least 12 months of follow-up)
- Quality of life assessment using AFEQT(At least 12 months of follow-up)
- Serum drug concentrations of amiodarone and its metabolite desethylamiodarone.(At 1 month and 3 months after surgery.)
- Recurrence of atrial fibrillation (AF) lasting more than 30 seconds.(At least 12 months of follow-up, beyond the initial 3 month blanking period)
- Recurrence of atrial arrhythmias during the 3-month blanking period after atrial fibrillation (AF) surgery.(During the 3-month blanking period after atrial fibrillation (AF) surgery)
研究者
Xu Liu
Professor
Shanghai Chest Hospital