跳至主要内容
临床试验/NCT01650298
NCT01650298终止不适用

Pilot Study: Tailored Anticoagulation for Noncontinuous AF

Abbott Medical Devices20 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
64
试验地点
20
主要终点
Total Cumulative Days on Anticoagulation

研究概览

简要总结

The purpose of this study is to determine whether it is safe to stop anticoagulation medication in patients with a history of atrial fibrillation (AF) based on information from a pacemaker or implantable cardioverter defibrillator (ICD).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
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

  • Patient has a St Jude Medial device that is compatible with Merlin.net (remote monitoring)
  • Patient has history of atrial fibrillation (non-continuous)
  • Patient must be taking a a blood thinner medication other than warfarin or aspirin for atrial fibrillation
  • Patient is willing to complete a questionnaire

排除标准

  • Patient is in atrial fibrillation all of the time
  • Patient has a history of stroke or blood clot
  • Patient is on warfarin or coumadin
  • Patient cannot be taken off of his blood thinner medication due to another medical condition
  • Patient is not capable of sending a remote device transmission to doctor once a week

结局指标

主要结局

Total Cumulative Days on Anticoagulation

时间窗: one year

To assess the reduction in time on anticoagulation, the cumulative total number of days on anticoagulation for each group throughout the follow-up period was determined. This study was designed as a pilot/feasibility study and therefore was not powered to detect thromboembolic events. Per study protocol, all patients completed a 30 day run-in period following enrollment during which anticoagulation could not be stopped regardless of AT/AF burden.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (20)

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