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临床试验/NCT01503268
NCT01503268撤回4 期

Atrial Fibrillation After Catheter Versus Thoracoscopic Ablation Using Patient Activated Implantable Loop Recorders

Eastbourne General Hospital4 个研究点 分布在 1 个国家开始时间: 2012年11月1日最近更新:
适应症

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

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

发起方
Eastbourne General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Neil Sulke

Consultant Cardiologist

Eastbourne General Hospital

研究点 (4)

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