Fitbit Atrial Fibrillation From PPG Data Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Fitbit LLC
- 入组人数
- 450,000
- 试验地点
- 2
- 主要终点
- Simultaneous measurement of AF ≥ 30 seconds with detection
研究概览
简要总结
Validate the Fitbit PPG RhythmDetect Software System algorithm for providing notifications by identifying rhythms suggestive of atrial fibrillation or atrial flutter events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 22 years of age or older
- •Capable of giving informed consent
- •U.S. resident
- •No prior history of atrial fibrillation or atrial flutter
- •Fitbit account, with one of the following devices paired:
- •Ionic, Versa, Versa Lite, Versa 2, Versa 3, Charge 3, Charge 4, Inspire HR, Inspire 2, or Sense updated to the latest available firmware.
排除标准
- •Diagnosis or history of Atrial Fibrillation at time of consent
- •Diagnosis or history of Atrial Flutter at time of consent
- •Current use of anticoagulation medication
- •Cardiac pacemaker or implantable cardioverter-defibrillator
研究组 & 干预措施
Detection Notification
Pulse rate data will be collected from a commercial device worn on the wrist. ECG will be collected from a single lead ambulatory ECG patch worn on the chest. The data from both the commercial wrist-worn device and the ECG patch are not analyzed real-time.
干预措施: Single lead ambulatory ECG patch (Diagnostic Test)
Non Detection Notification
Pulse rate data will be collected from a commercial device worn on the wrist.
结局指标
主要结局
Simultaneous measurement of AF ≥ 30 seconds with detection
时间窗: 7 days
Simultaneous measurement of AF ≥ 30 seconds on ECG patch monitor during any of the pulse tachograms that generate the first Irregular Heart Rhythm Detection during ECG monitoring.
次要结局
- Simultaneous measurement of AF ≥ 30 seconds with pulse tachograms(7 days)