Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 3
- 主要终点
- Time until any documented episode of ATa
研究概览
简要总结
Additional left atrial appendage isolation during balloon ablation for persistent or long-standing persistent atrial fibrillation can reduce atrial fibrillation reoccurrence within 3-12 months compared to balloon-based pulmonary vein isolation only.
详细描述
The intervention in the LALA-LAND-AF trial is the additional LAAI in patients with catheter ablation for persistent AF and will be performed once as index ablation as outlined above. With exception of the index ablation, all patients will be treated according to the current clinical practice guidelines for AF as stated by the European Society of Cardiology (ESC) 11,18 and an expert consensus statement on catheter and surgical ablation1. Patients may be treated with a specific antiarrhythmic drug (AAD) for a maximum of 3 months following the index ablation. No repeat ablation for AF should be performed within the first 3 months. Thereafter, repeat ablations are permitted for recurrent AF irrespective of group allocation. Ablation strategy at repeat ablation includes PV re-isolation if required in both groups and re-isolation of the LAA in the intervention group. In the control group, LAAI may only be performed in case all PV were isolated.
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
- •Persistent or long-standing persistent AF (i.e. continuous AF that was/is sustained >7 days or >12 months, respectively)
- •Age ≥18 and ≤80 years
- •Indication for AF ablation as per current guidelines
排除标准
- •Missing informed consent
- •LAA diameter >25mm 10mm distant from circumflex artery assessed by TEE
- •Paroxysmal atrial fibrillation
- •Long-standing persistent atrial fibrillation with a continuous AF duration of >4 years
- •Previous pulmonary vein isolation or MAZE surgery
- •Previous led atrial appendage closure or surgical excision
- •Left atrial diameter >60 mm at baseline
- •Left atrial thrombus at baseline
结局指标
主要结局
Time until any documented episode of ATa
时间窗: 3 - 12 months
Time until any documented episode of atrial tachyarrhythmia (ATa: atrial fibrillation or atrial tachycardia) lasting longer than 30 seconds within 3-12 months after index ablation without antiarrhythmic therapy
次要结局
未报告次要终点
研究者
Roland Richard Tilz, MD
Head of Electrophysiology Department
University of Luebeck