Validation of Digital Heart Rhythm Devices in the Detection of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Cramer's V
研究概览
简要总结
The VALIDATION study aims to evaluate the performance of four state-of-the-art digital heart rhythm devices (Preventicus®, FibriCheck®, Apple Watch®, 6L Kardia Mobile®) for the detection of atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 是
入选标准
- •The patient is an ambulatory cardiology patient.
- •The patient is at least 18 years old.
- •The patient is sinus or in atrial fibrillation.
- •The patient is able to perform the study procedures together with the study assistant.
排除标准
- •Patients with a pacemaker
- •Inclusion in another clinical trial that may influence the results of this trial
- •The patient is unable to comprehend the informed consent.
结局指标
主要结局
Cramer's V
时间窗: During the heart rhythm measurements
The association of between the classification by the device of interest versus the 12-lead ECG, expressed as Cramer's V.
Sensitivity
时间窗: During the heart rhythm measurements
Proportion of true positives tests with the device of interest out of all patients with AF on the 12-lead ECG.
Accuracy
时间窗: During the heart rhythm measurements
Proportion of correct classifications with the device of interest. Correct classification is provided by the 12-lead ECG.
Specificity
时间窗: During the heart rhythm measurements
Proportion of true negative tests with the device of interest out of all patients in sinus rhythm on the 12-lead ECG.
次要结局
- Negative predictive value(During the heart rhythm measurements)
- Patient preference score (for the use of the diagnostic devices)(During the heart rhythm measurements)
- Positive predictive value(During the heart rhythm measurements)