Continuous Data Collection and Analysis for Stroke Prevention Using a Wearable Sensor
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Watch Accuracy compared to BodyGuardian
研究概览
简要总结
The purpose of this study is to determine whether a wristband that detects your pulse can detect your heart rate and rhythm similar to electrocardiograms (ECG).
详细描述
The purpose of this study is to determine whether a wristband that detects your pulse can detect your heart rate and rhythm similar to electrocardiograms (ECG). These wristbands detect your pulse based on a technique called "photoplethysmography," (PPG). PPG is a common method in which an individual's pulse is detected based on a light signature interpreted by the wristband. Most commercially available heart rate monitors use PPG to determine your heart rate, but the accuracy is variable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Male or female 18 years of age or older with a primary diagnosis of atrial fibrillation
- •Willing and able to provide informed consent and follow the study protocol
- •Clinically indicated planned restoration of normal rhythm
排除标准
- •Unable to provide informed consent
- •Unable to follow the study protocol
- •Women who are pregnant
- •Subjects with implantable devices (only if participating in phase 2-BodyGuardian processes/testing)
结局指标
主要结局
Watch Accuracy compared to BodyGuardian
时间窗: 30 days
Determine the accuracy of ambulatory photoplethysmography for detection of heart rhythm when compared with a wearable clinically available 30 day monitor (BodyGuardian) in terms of accuracy of AF detection.
Watch Accuracy during Cardioversion
时间窗: Duration of cardioversion procedure
Determine whether the R-R interval estimate from artifact-free non-invasive photoplethysmography sample waveform segments is a reasonable basis for a atrial fibrillation (AF) detection algorithm as compared to a gold standard measurement from ECG in the acute cardioversion setting
次要结局
未报告次要终点