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临床试验/NCT04375241
NCT04375241已完成不适用

Detection of Asymptomatic Atrial Fibrillation in Persons of 65 Year of Age or Older

Diagram B.V.1 个研究点 分布在 1 个国家目标入组 2,168 人开始时间: 2018年7月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,168
试验地点
1
主要终点
Specificity of the mobile ECG device

研究概览

简要总结

Atrial fibrillation (AF) is the most common cardiac arrhythmia. Although the condition itself is not life-threatening, the complications result in increased morbidity and mortality. AF is often asymptomatic and a considerable number of people suffering from AF are not aware of their condition. Unfortunately, a cerebral infarction is often the first clinical manifestation. The idea to screen subjects opportunistically for Asymptomatic Atrial Fibrillation (AAF) was infeasible until recently. However, with a recently-developed smartphone connected Mobile ECG Device (MED), this seems to be feasible after all.

The main objectives are:

  • To examine the feasibility of screening subjects of ≥65 years old for AAF.
  • To validate the smartphone connected MED as an AAF screening instrument for application in transmural care in the Netherlands.

详细描述

Study design:

Prospective validation study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥65 years
  • Is willing to give informed consent

排除标准

  • Known medical history with Atrial Fibrillation
  • Not mental competent

结局指标

主要结局

Specificity of the mobile ECG device

时间窗: At screening

Sensitivity of the mobile ECG device

时间窗: At screening

次要结局

未报告次要终点

研究者

发起方
Diagram B.V.
申办方类型
Other
责任方
Sponsor

研究点 (1)

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