Video-Assisted Thoracoscopic Pulmonary Vein Isolation Versus Percutaneous Catheter Ablation in Atrial Fibrillation Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Recurrence of AF
研究概览
简要总结
Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) and surgically video assisted thorascopic pulmonary vein isolation (VATS-PVI) are acceptable or even superior alternatives to antiarrhythmic drug therapy in patients with symptomatically paroxysmal atrial fibrillation (AF). However, data comparing effectiveness in both interventions are limited.
The investigators want to compare the effectiveness of PVI and VATS-PVI. Secondary objectives are to compare the duration of hospitalization, quality of Life, cost and to compare the satisfaction of the patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years of age
- •Documented, symptomatic, episodes of paroxysmal or persistent AF
- •During the last 6 months patients must have at least 2 documented episodes of AF, despite the use of at least 1 anti arrhythmic drug.
- •Able of providing informed consent
排除标准
- •Pregnancy
- •Unwillingness to use or contra-indications for vitamin K antagonists
- •Severely enlarged left atrium (>50 mm) on echocardiography
- •Prior AF ablation or AF surgery
- •Intracardiac thrombus
- •Prior heart surgery or pulmonary disease hampering thoracoscopic surgery
结局指标
主要结局
Recurrence of AF
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
- Treatment impact(one year)
研究者
B. Oude Velthuis
B. Oude Velthuis MD
Medisch Spectrum Twente