Concomitant Epicardial Pulmonary Vein Isolation in Patients With Atrial Fibrillation Undergoing Elective Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Recurrence of atrial fibrillation
研究概览
简要总结
Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) is a superior alternative to antiarrhythmic drug therapy in patients with symptomatical paroxysmal atrial fibrillation (AF). A substantial proportion of patients undergoing elective cardiac surgery also suffer from atrial fibrillation. No evidence exists if epicardial PVI is beneficial in patients with a history of AF undergoing coronary bypass surgery (CABG) for the concomitant treatment of AF. The investigators aim to establish the effectiveness of incorporating epicardial pulmonary vein isolation into elective cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years of age
- •EHRA class ≤ 2
- •Documented history of paroxysmal, persistent, longstanding persistent or newly-diagnosed AF prior to admittance for cardiac surgery
- •Patients will have elective coronary surgery planned Able of providing informed consent
排除标准
- •Patients ≥70 years of age
- •Pregnancy Patients with contraindications for oral anticoagulant agents
- •Patients undergoing emergency operation
- •Patients undergoing concomitant valve replacement
- •Severely enlarged LA (>50 mm) on echocardiography
- •Prior AF ablation or AF surgery
结局指标
主要结局
Recurrence of atrial fibrillation
时间窗: one year
The percentage of patients without a recurrence of AF, without antiarrhythmic drugs (AADs), within a follow-up period of at least 12 months after a stabilisation period of 90 days after the initial procedure. An episode of AF is defined as an episode of at least 30 seconds duration.
次要结局
- Duration of hospitalization(One year)
研究者
B. Oude Velthuis
B. Oude Velthuis MD.
Medisch Spectrum Twente