Study Watch Atrial Fibrillation (AF) Detection Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Estimate of the accuracy of algorithm based PPG irregular rhythm detection in a study population with a history of paroxysmal or persistent atrial fibrillation (AF)
研究概览
简要总结
This is a prospective, non-randomized study to refine the Study Watch's algorithm for AF detection within both persistent and paroxysmal AF subjects. The study will also collect data from an FDA-cleared wearable ECG sensor.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old
- •Able to read and speak English
- •Able and willing to sign written Informed Consent
- •Interest in participating in the study
- •Subjects with a known history of AF (including persistent or paroxysmal AF)
- •Without significant limitation in ability to participate in the study, in the opinion of the investigator.
排除标准
- •Currently in a paced rhythm
- •Known severe allergy to nickel or metal jewelry
- •Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies
结局指标
主要结局
Estimate of the accuracy of algorithm based PPG irregular rhythm detection in a study population with a history of paroxysmal or persistent atrial fibrillation (AF)
时间窗: At least 60 minutes
Sensitivity estimate for PPG irregular rhythm detection vs. a multi-lead Holter ECG rhythm
PPG- and ECG-based continuous AF-detection algorithms on Study Watch in a free-living (home) setting by comparing the Study Watch data with an FDA-cleared wearable ECG sensor data.
时间窗: 14 days
Number of AF events identified from FDA-cleared ECG Device
次要结局
- Spontaneously-reported participant usability feedback for Study Watch and its ECG feature in a free-living (home) setting with the target AF population.(14 days)
- Estimate of the accuracy of algorithm based PPG irregular rhythm detection in a study population with a history of paroxysmal or persistent atrial fibrillation (AF)(At least 60 minutes)