NCT01582828撤回不适用
Serial Hybrid Atrial Fibrillation Ablation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Atrial fibrillation Freedom
研究概览
简要总结
Treatment of (long-standing) persistent atrial fibrillation (AF) remains cumbersome and the surgical (epicardial) approach seems to be the most effective. Still, however a significant amount of failures exist which is mostly due to incompleteness of the surgical ablation lines. Checking, and if necessary additional ablation, of these lines afterwards endocardially by the cardiologist (the so-called serial hybrid approach) could overcome this problem.
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
- •patients are screened and accepted for pulmonary vein isolation according to the current guidelines
- •long standing persistent or persistent AF as defined in the guidelines
- •left atrial size needs to be more than >46 mm on long axis or >35 cc/m2
- •CHADSVASC score should be more than 0 as an indicator of a substantial substrate for atrial fibrillation.
排除标准
- •Significant coronary artery disease has to be excluded as a trigger for AF by means of cardiac CT, if necessary a coronary angiogram will be performed.
- •Previous PVI ablation (epicardial or endocardial) or cardiac surgery.
- •Significant valvular disease present on echo.
- •Concomitant cardiac surgery needed.
结局指标
主要结局
Atrial fibrillation Freedom
时间窗: 12 months
left sided atrial flutter and left atrial tachycardia
次要结局
- re-isolation(8-10 weeks)
- Percentage of cross-over(1 year)
- Complications(1 year)
- Atrial fibrillation Burden(1 year)
研究者
B. Oude Velthuis
Research fellow electrophysiology
Medisch Spectrum Twente
研究点 (2)
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