Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation Assessed by Continuous Rhythm Monitoring
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- AF recurrences
研究概览
简要总结
The purpose of this study is to collect data on laser ballon (2nd gen) systems for catheter ablation for AF, in order to determine the safety and the efficacy of this technique.
Moreover, the investigators aim to determine the short and long term outcomes of pulmonary vein isolation evaluating arrhythmia recurrence, especially using continuous rhythm monitoring with implantable loop recorders (ILR).
详细描述
LIGHT-AF is an observational, multicentric study designed to collect pre-procedural, procedural and follow-up data of consecutive patients that underwent catheter ablation for AF with laser ballon (2nd gen system). A number of 3 enrolling centers is estimated with an overall number of about 100 patients. A minimal follow-up of 3 months is required before analyzing clinical outcomes. The data analysis will focus on implant outcomes and early, mid and long-term recurrence of AF, evaluated with intracardiac rhythm monitoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Age >/= 18 years
- •Patients with paroxysmal, persistent or long-standing persistent AF
- •Patients able to provide written informed consent or have informed consent as provided by a legal representative
排除标准
- •Age < 18 years
- •Patients unable or unwilling to receive oral anticoagulation
结局指标
主要结局
AF recurrences
时间窗: 2 years
Time to first recurrence of symptomatic or asymptomatic atrial tachyarrhythmias
次要结局
- Arrhythmia burden(2 years)
- Redo ablation procedures(2 years)
- Adverse events(2 years)
研究者
Giovanni B Forleo
Section Head Electrophysiology
Luigi Sacco University Hospital