Randomized Clinical Trial of Additional Left Atrial Posterior Wall Isolation for Persistent Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 276
- 试验地点
- 2
- 主要终点
- Recurrence of atrial tachyarrhythmia after 90-day blanking period of catheter ablation
研究概览
简要总结
The purpose for this study is to determine whether left posterior wall isolation (PWI) in addition to pulmonary vein isolation (PVI) is effective as ablation strategy for persistent atrial fibrillation (AF).
详细描述
PVI is cornerstone of AF ablation. However, clinical outcome of only PVI in patients with persistent AF is insufficient due to AF substrate extending to left atrium. Strategy of catheter ablation for persistent AF is not established despite attempts of numerous left atrial substrate modifications. Additional PWI on PVI is one of expected effective strategies for persistent AF, because PW originated from common tissue of PV and is considered to play a part in AF trigger and maintenance. However, this strategy is also not established in the recent international consensus statement. Following two reasons are considered. One is the procedural difficulty in creating durable PWI, and another is the existence of patients who can recover by only PVI. The latest technology, ablation index, can create durable PVI, and may create durable PWI. Several reports suggested that PVI only strategy was sufficient in the patients with persistent AF who could maintain sinus rhythm after pharmacological or electrical cardioversion. Therefore, we planed this randomized clinical trial that compared between PVI alone and additional PWI on PVI using ablation index in the patients with persistent AF without pharmacological sinus rhythm conversion.
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
- Single (Participant)
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
- •Patients scheduled for first catheter ablation of persistent atrial fibrillation
- •Patients without conversion to sinus rhythm within 30 days after antiarrhythmic drug administration
- •Patients with persisting duration of atrial fibrillation less than 3 years
- •Patients with left atrial diameter less than 50mm
- •Patients who can be followed up for 18 months
- •Patients with written informed consent
排除标准
- •Patients who can not be received adequate anticoagulation therapy
- •Patients with history of myocardial infarction within 6 months
- •Patients with history of open heart surgery
- •Patients scheduled for open heart surgery
- •Patients with severe valvular heart disease
- •Patients during pregnancy
- •Patients with expected life expectancy less than 1 year due to malignancy or non-cardiovascular disease
- •Patients considered unsuitable for study by the attending physician
结局指标
主要结局
Recurrence of atrial tachyarrhythmia after 90-day blanking period of catheter ablation
时间窗: 18 months
Recurrence of atrial tachyarrhythmia is defined atrial arrhythmia that needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.
次要结局
- Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of catheter ablation(18 months)
- Recurrence of atrial fibrillation or atrial tachycardia within 90-day after catheter ablation(90 days)
- Atrial Fibrillation Quality of Life Questionnaire(18 months)
- Repeated ablation of atrial tachyarrhythmia(18 months)
- Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of repeated ablation(18 months)
- Complications of ablation procedure(1 month)