Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- time to AF and AT recurrence
研究概览
简要总结
to assess the near-term (12 months) efficacy of pulmonary vein isolation.
详细描述
The aim of the study was to assess the near-term (12 months) efficacy of pulmonary vein isolation using a standard approach compared to application of an additional acute procedural endpoint of unexcitability along the ablation line.
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
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •written informed consent
- •age > 18 years
- •paroxysmal atrial fibrillation
排除标准
- •structural heart disease
- •intracardiac thrombus
- •reversible causes of atrial fibrillation
- •inability to take warfarin
研究组 & 干预措施
Loss of pace capture
Pulmonary vein isolation: Ablation along the ablation line is continued until loss of pace capture along the ablation line is achieved
catheter based pulmonary vein isolation
干预措施: catheter based pulmonary vein isolation (Device)
Conventional
Pulmonary vein isolation: Ablation is discontinued when electrical isolation of the pulmonary veins is achieved.
catheter based pulmonary vein isolation
干预措施: catheter based pulmonary vein isolation (Device)
结局指标
主要结局
time to AF and AT recurrence
时间窗: 12 months
recurrence of AF as assessed by 3 day holter monitoring, assessment of AT recurrence using 3 day holter monitoring
次要结局
- procedure duration(completed (15 months))
- procedure safety(up to three days after the procedure)