Long-Term Cardiac Monitoring for Detection of Atrial Fibrillation After Cryptogenic Stroke

Transoma Medical2 个研究点分布在 1 个国家目标入组 100 人开始时间: 2009年3月最近更新: 2009年5月5日

适应症

试验速览

阶段: 不适用
发起方: Transoma Medical
入组人数: 100
试验地点: 2
主要终点: Incidence of atrial fibrillation at one year from Sleuth implantation.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine whether the Sleuth Implantable Loop Recorder will enhance detection of latent atrial fibrillation in patients after cryptogenic stroke.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Diagnostic
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: 否

入选标准

•Recent stroke (within 30 days) as defined by who has a sudden onset of focal neurological deficits presumed vascular etiology and lasting more than 24 hours.
•Negative brain image for hemorrhagic stroke
•In sinus rhythm at time of enrollment

排除标准

•Know history of atrial fibrillation
•Previous implanted cardiac device (ppM or ICD)
•Serious illness making it unlikely to survive one year
•Known secondary cause of stroke

结局指标

主要结局

Incidence of atrial fibrillation at one year from Sleuth implantation.

时间窗: One Year

次要结局

未报告次要终点

研究者

发起方

Transoma Medical

申办方类型

Industry

研究点 (2)

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