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临床试验/NCT01891825
NCT01891825暂停不适用

Persistent Atrial Fibrillation Ablation Trial

Neil Sulke4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
50
试验地点
4
主要终点
Recurrence of persistent AF by 12 months after ablation

研究概览

简要总结

Persistent atrial fibrillation (AF) is a common and distressing condition, that can cause significant symptoms. AF ablation is a recognised technique to treat persistent AF, but can be technically difficult. This study compares percutaneous ablation to thoracoscopic surgical AF ablation.

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 or long-standing AF suitable for AF ablation.
  • Age over 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

Recurrence of persistent AF by 12 months after ablation

时间窗: 12 months

Mean time to recurrence of persistent AF after ablation

次要结局

  • Time to first episode of symptomatic AF after ablation(12 months)
  • Time to first episode of any AF after ablation(12 months)
  • Total number of AF episodes after AF ablation(12 months)
  • Total number of AF episodes lasting greater than 6 minutes after AF ablation(12 months)
  • New MRI-detected subclinical cerebral embolic events(3 months)
  • Change in AF burden after AF ablation(12 months)

研究者

发起方
Neil Sulke
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Neil Sulke

Principal Investigator

Eastbourne General Hospital

研究点 (4)

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