Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Time to first day with ATA burden of 12 hours or greater
研究概览
简要总结
RABLAP-AF will compare pulmonary vein isolation (PVI) in combination with posterior wall isolation (PWI) for patients with persistent atrial fibrillation (AF).
详细描述
Ablation for AF has a high success rate for patients with paroxysmal AF, but success rates for persistent AF remain significantly lower. These patients frequently have more advanced disease in their left atrium than those with paroxysmal AF.
A common practice is to perform left atrial PWI in addition to PVI in order to reduce AF recurrence. This approach has conflicting evidence behind it and a large scale clinical trial in those with advanced disease is required. The investigators hope to fill this gap with RABLAP-AF.
The investigators will randomise patients with advanced atrial disease 1:1 to PVI+PWI or PVI alone. All patients will receive implantable loop recorders two months prior to the ablation procedure in order to accurately assess the effect of PWI and compare arrhythmia burden before and after ablation.
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 (Outcomes Assessor)
盲法说明
Patients and operators will be aware of the treatment arm. Researchers interpreting and assessing outcome data will be blinded to treatment received.
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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Time to first day with ATA burden of 12 hours or greater
时间窗: From 3 months post ablation to 12 months
Time to day with atrial tachyarrhythmia burden lasting 12 hours or greater, following a 3 month blanking period post-ablation
次要结局
- Time to first day with ATA burden of 24 hours(From 3 months post ablation to 12 months)
- Difference in AFEQT questionnaire between baseline and month 12(12 months)
- Use of direct current cardioversion or repeat ablation(From 3 months post ablation to 12 months)
- Number of patients with >= 75% reduction in cumulative burden of AF between pre-ablation and months 3-12(12 months)
- Use of antiarrhythmic drugs from month 3 onwards(From 3 months post ablation to 12 months)
- Time to first day with ATA burden of 60 minutes or greater(From 3 months post ablation to 12 months)
- Difference in EQ5D questionnaire between baseline and month 12(12 months)
- Difference in VAS between baseline and month 12(12 months)
- Reduction in burden of AF between pre-ablation and months 3-12(12 months)