Atrial Fibrillation After Catheter Versus Thoracoscopic Ablation Using Patient Activated Implantable Loop Recorders
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Time to recurrence of persistent AF
研究概览
简要总结
Atrial fibrillation (AF) is a common but often distressing condition. It can be treated with medications, but these are not always effective or tolerated. Ablation is a well-recognised technique that is recommended for those with symptomatic AF who have failed medical therapy.
Ablation can be performed in a number of ways. In percutaneous ablation, ablation is performed via tiny punctures in the skin in the groin. In minimally-invasive thoracoscopic ablation, ablation is performed under general anaesthetic via very small incisions in the chest wall.
Because AF can be intermittent, the only reliable way to look for it is with long-term ECG monitoring. A safe and practical way to do this is to use implantable loop recorders (ILRs).
In this study, the investigators are trying to see if minimally-invasive thoracoscopic ablation is better than percutaneous ablation, and in turn if they are better than Direct current cardioversion (DCCV), using ILRs to monitor AF.
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 persistent atrial fibrillation
- •Age over 18 years
- •Informed consent
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.
- •Patients unable to undergo general anaesthesia for AF ablation.
- •Previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery
- •Previous thoracic surgery
- •Participation in a conflicting study
- •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
Time to recurrence of persistent AF
时间窗: 1 year
Reduction in AF burden after ablation
时间窗: One year
Reduction in proportion of time in atrial fibrillation as detected by an implantable loop recorder
次要结局
- New MRI-detected subclinical cerebral ischaemia(1 year)
- Time to recurrence of atrial fibrillation after ablation(One year)
- Time to recurrence of symptomatic atrial fibrillation after ablation(One year)
研究者
Neil Sulke
Consultant Cardiologist
Eastbourne General Hospital
