Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study 2
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- AF burden
研究概览
简要总结
This study is designed to compare three different techniques in ablation of paroxysmal atrial fibrillation. Namely, the Medtronic multi-electrode phased radiofrequency ablation system, the Biosense Webster irrigated multi-electrode phased radiofrequency ablation system, and minimally invasive thoracoscopic surgical ablation. The study hypothesis is that surgical and Biosense Webster ablation are non-inferior to Medtronic ablation.
详细描述
A target of 75 participants will be randomised 1:1:1 to one of the three treatment arms. Each participant will have an implantable loop recorder (ILR) prior to ablation in order to assess AF burden. After ablation, each participant will be followed up for a year. The ILR will be used to assess reduction in AF burden.
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
- •Symptomatic paroxysmal AF suitable for AF ablation
- •Age > 18 years old
- •Informed consent to participate in this study.
排除标准
- •Pre-existing ILRs or permanent pacemakers that do not allow for continuous monitoring for AF occurrence, or are not MRI-safe.
- •Unable to undergo general anaesthesia for AF ablation.
- •Previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery.
- •Scheduled for elective cardiac surgery, such as coronary artery bypass grafting or valvular surgery.
- •Previous thoracic surgery.
- •Participation in a conflicting study.
- •Potential participants who are mentally incapacitated and cannot consent or comply with follow-up
- •Pregnancy
- •Other cardiac rhythm disorders
结局指标
主要结局
AF burden
时间窗: 12 months after ablation
Total proportion of time spent in AF as assessed by ILR
次要结局
- Time to AF recurrence(Up to one year)
- Time to first symptomatic AF recurrence(Up to one year)
- Change in QoL measures(12 months after ablation)
研究者
Neil Sulke
Consultant Cardiologist
Eastbourne General Hospital