NCT06282380已完成不适用
Fibricheck Detection cApabilities for Atrial Fibrillation - a Multicenter Validation Study
Qompium NV9 个研究点 分布在 2 个国家目标入组 330 人开始时间: 2024年2月26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
- 330
- 试验地点
- 9
- 主要终点
- Accuracy of the FibriCheck Mobile Application
研究概览
简要总结
Evaluation of accuracy of the FibriCheck Mobile Application on various smartphone devices, compared to the reference diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 22 years old;
- •Capable of independently performing FibriCheck recordings (researcher-observed);
- •Cardiology patients, hospitalized/in-clinic or consulting the cardiac outpatient clinic, with or without a diagnosis of atrial fibrillation.
排除标准
- •Individuals with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can influence the natural heart rhythm;
- •Individuals enrolled in another clinical trial;
- •Individuals with physical or medical characteristics that prevent them from successfully taking a measurement e.g. extreme callus (i.e., rough or thickened area of skin fingertip), tremor, cognitive impairment, Parkinson's disease;
- •Pregnant and/or nursing women.
结局指标
主要结局
Accuracy of the FibriCheck Mobile Application
时间窗: Through study completion: 1 day
Accuracy based on the reference diagnosis
次要结局
- Sensitivity of the FibriCheck Mobile Application(Through study completion: 1 day)
- Specificity of the FibriCheck Mobile Application(Through study completion: 1 day)
研究者
研究点 (9)
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