HeartLight Guided - Pure Pulmonary Vein Isolation Regardless of Concomitant Atrial Substrate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Freedom from atrial fibrillation and atrial tachyarrhythmias
研究概览
简要总结
Aim of the present prospective, single-centre study is to determine the outcome after pure PVI using HeartLight™ in 100 patients with different extents of LA-LVA.
The latter will be assessed by an electro-anatomical voltage map using a commercial 3D mapping system (CARTO, Biosense Webster).
详细描述
The ablation strategy for patients with atrial fibrillation (AF) and concomitant atrial substrate (e.g. low-voltage areas; LVA) is a matter of controversy.
Results of studies investigating the impact of LVA may have been confounded by PV-to-left-atrial (LA) reconnection due to non-durable ablation. Therefore, the true contribution of LA-LVA to AF recurrences remains unknown.
Meanwhile, new ablation technologies such as the HeartLight™ laser balloon (LB) ablation system providing near complete chronic PVI rates have been developed.
Aim of the present prospective, single-centre study is to determine the outcome after pure PVI using HeartLight™ in 100 patients with different extents of LA-LVA.
The latter will be assessed by an electro-anatomical voltage map using a commercial 3D mapping system (CARTO, Biosense Webster).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Symptomatic atrial fibrillation
- •Left atrial size <50mm
- •Left ventricular ejection fraction <45%
- •Patient is able to provide informed consent
排除标准
- •Contraindications for PVI
- •Previous PVI attempts
- •Inability to be treated with oral anticoagulation
- •Presence of intracardiac thrombi
- •Pregnancy
- •Participation in other clinical studies
- •Unwilling to follow the study protocol and to attend follow-up visits
研究组 & 干预措施
Treatment
PVI with HeartLight
干预措施: PVI with HeartLight (Device)
结局指标
主要结局
Freedom from atrial fibrillation and atrial tachyarrhythmias
时间窗: 12 months
72h Holter-ECG recordings will be performed. In case of clinical arrhythmia symptoms event-recording will be provided.
次要结局
未报告次要终点
研究者
Boris Schmidt
Head of Department
Cardioangiologisches Centrum Bethanien