Laser Ablation Study for trEatment of atRial Fibrillation (LASER)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Presence of large gaps in the delayed enhancement MRI (DE-MRI)
研究概览
简要总结
This protocol aims at assessing the efficacy of performing catheter ablation for atrial fibrillation (AF) with laser catheters versus performing it with radiofrequency (RF) catheters. In order to study laser catheter ablation efficacy, MRI analysis of the lesions 3 months after the procedure will be performed in both groups. MRI analysis will detect ablation gaps in the lesions encircling pulmonary veins. The primary endpoint will compare the number of gaps in the laser catheter and the RF group. The secondary endpoint of the study is recurrence of AF after 12 months. The target population of the study is patients with paroxysmal or persistent AF undergoing AF ablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinical recurrent AF, refractary or intolerant to at least 1 antiarrhythmic drub who are scheduled to undergo ablation of pulmonary veins (PV)
- •Signed consent form.
排除标准
- •Being under 18 years old
- •Any contraindication for ablation procedure
- •Impossibility to acquire DE-MRI because of contraindication (e.g. severely impaired renal function) or patient unwillingness
研究组 & 干预措施
Laser ablation
Ablation with laser catheter
干预措施: Laser ablation (Device)
RF ablation
Ablation with RF catheter
干预措施: RF ablation (Device)
结局指标
主要结局
Presence of large gaps in the delayed enhancement MRI (DE-MRI)
时间窗: 3 months
The presence of MRI ablation gaps around the pulmonary veins evaluated with MRI images of the patient acquired three months after the ablation procedure. A large gap is described as a GAP that is larger or equal than 20% of the vein perimeter.
次要结局
- To determine the number of patients that present atrial fibrillation after the ablation procedure(1 year)
研究者
Josep Lluis Mont Girbau
MD Phd
Hospital Clinic of Barcelona