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临床试验/NCT01407588
NCT01407588已完成不适用

Manual Compared to Magnetic Navigation in Ablation for Atrial Fibrillation

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
Number of participants with recurrence of atrial fibrillation after ablation

研究概览

简要总结

The purpose of this study is to compare manual and magnetic navigation in ablation for atrial fibrillation.

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
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Undergoing ablation for atrial fibrillation at St. Olavs Hospital
  • Implanted Reveal

排除标准

  • 未提供

结局指标

主要结局

Number of participants with recurrence of atrial fibrillation after ablation

时间窗: 2 years

If the patient have had recurrence or not of atrial fibrillation after ablation. An implanted arrhythmia loop recorder (Reveal XT) is used for monitoring. Recurrence is defined as an attack of atrial fibrillation of more than 2 minutes. It will also be specified if the patient is referred for a second ablation procedure.

次要结局

  • Quality of life(2 years)
  • Exposure of radiation to health personnel involved in the procedure(Day 1(after ablation procedure))
  • Amount of analgetics and sedatives given during procedure(Day 1)
  • Procedure time(Day 1(after ablation procedure))
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Day 1(after ablation procedure))
  • Numbers of and types of catheters used(During ablation(Day1))
  • Time with active ablation(During the procedure(Day 1))
  • Cardiac volumes and function(1 year)
  • Pain(After ablation(day 1))
  • Total time nurses are occupied with the ablation(During the ablation(day 1))
  • Myocardial damage(After ablation(day 1))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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