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临床试验/NCT00806689
NCT00806689Unknown不适用

Full Disclosure Observational Cardiac Rhythm Documentation Follow-up After Surgical Atrial Fibrillation Therapy

University of Luebeck1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Atrial fibrillation burden development after surgical ablation therapy

研究概览

简要总结

24 hour Holter monitoring (24HM) is commonly used to assess cardiac rhythm after surgical therapy of atrial fibrillation. This "snapshot" rhythm documentation leaves a large diagnostic window of non recorded atrial arrhythmias and as such a large amount of uncertainty in follow-up result assessment. To improve accuracy of rhythm surveillance thus gaining a more "real-life" scenario of post surgical ablation therapy cardiac rhythm a new insertable cardiac rhythm monitor device (Reveal® XT 9525, Medtronic Inc., Minneapolis, MN, USA) with full observational continuous heart rhythm documentation is implanted.

In order to verify different follow-up strategies after surgical atrial fibrillation therapy, a comparison of different follow-up scenarios (symptoms, different cardiac documentation devices i.e. ECG and 24 hour Holter monitor, at different follow-up time points) is performed intraindividually. Thus the reliability of these devices and follow-up strategies to define success after ablation therapy is evaluated.

研究设计

研究类型
Observational
观察模型
Cohort

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

  • patients in atrial fibrillation (AF duration >4 months)being scheduled for cardiac surgery
  • patients with lone atrial fibrillation being scheduled for surgical AF treatment

排除标准

  • failure to provide informed consent
  • current participation in another clinical trial
  • organic cause of atrial fibrillation (hyperthyroidism etc.)

结局指标

主要结局

Atrial fibrillation burden development after surgical ablation therapy

时间窗: 3 years

次要结局

  • Comparison of different cardiac rhythm documentation strategies to define success after ablation therapy(3 years)

研究者

发起方
University of Luebeck
申办方类型
Other

研究点 (1)

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