The Modified "Pills-in-the-Pocket" Strategy -The Combined Effect of Amiodarone, Bisoprolol and Digoxin in the Treatment of Recurrent Atrial Arrhythmia for Non-Paroxysmal Atrial Fibrillation After Catheter Ablation: A Multicenter, Prospective, Randomized, Open-Label, Blinded Endpoint Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- converted to sinus rhythm
研究概览
简要总结
This is a multicentre, prospective, randomised controlled study of 328 patients with non-paroxysmal AF (within 5 years of first diagnosis of AF) with recurrent atrial arrhythmias after first catheter ablation, randomly divided in a 1:1 ratio into a study group treated with triple AADs (amiodarone + bisoprolol + digoxin) and a control group treated with conventional AADs (amiodarone + bisoprolol + digoxin). The study group was treated with triple AADs (amiodarone + bisoprolol) and the control group was treated with conventional AADs (amiodarone + bisoprolol) with the aim of comparing the efficacy and safety of the two groups in terms of reversion of SR, which may provide an effective option of pocket drug reversion for patients with recurrence of SR after AF catheter ablation.
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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
- None
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
- •(1) Age ≥18 years; (2) Non-valvular, non-paroxysmal AF (within 5 years of the first diagnosis of AF) with recurrent atrial arrhythmia lasting for more than 24 hours after the first catheter ablation and not self-terminating; (3) Patients who are not taking AADs such as amiodarone, dronedarone, propafenone, etc. after the procedure, and who agree to receive AADs without contraindications to AADs; or patients who are taking AADs such as amiodarone, dronedarone, propafenone, etc. after the procedure, but have been off of them for more than 1 month.
排除标准
- •(1) Previous cardiac surgery, such as cardiac bypass grafting, mechanical valve or prosthetic valve replacement; (2) Combined cardiomyopathy (e.g. hypertrophic cardiomyopathy, dilated cardiomyopathy, ischaemic cardiomyopathy, etc.); (3) Cardiac ultrasound suggests that the diameter of the left atrium is ≥50mm or there are valvular changes in rheumatic heart disease; (4) Previous history of abnormal thyroid function; (5) Severe hepatic or renal insufficiency (eGFR <15, Child Class 3), or history of renal dialysis; (6) Heart rate <60 beats/minute, any degree of atrioventricular block, two-branch or three-branch block at the time of resumption of SR after catheter ablation; (7) Left ventricular ejection fraction <40% or New York Heart Association (NYHA) class III-IV after catheter ablation; (8) Participation in a clinical trial of another drug or device during the same period; (9) Abnormalities or diseases that, in the opinion of the investigator, should be excluded from enrolment in this study.
研究组 & 干预措施
experimental group
use Amiodarone, Bisoprolol and Digoxin
干预措施: use Amiodarone, Bisoprolol and Digoxin (Drug)
control group
use Bisoprolol and Digoxin
干预措施: use Amiodarone, Bisoprolol and Digoxin (Drug)
结局指标
主要结局
converted to sinus rhythm
时间窗: 1 month
Patients with recurrent atrial arrhythmia after catheter ablation for non-paroxysmal AF (within 5 years of history of first AF diagnosis) within 1 month converted to sinus rhythm using AADs
次要结局
- Composite endpoint event of bradycardia, cardiovascular hospitalisation or death(1 month)
研究者
Yumei Xue
Chief physician of the first area of the heart
Guangdong Provincial People's Hospital