Validation of Withings BeamO With Withings ECG-App for the Detection of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Withings
- 入组人数
- 373
- 试验地点
- 4
- 主要终点
- Co-primary outcome 2 - Specificity of Investigational Device
研究概览
简要总结
The aim of the study is to evaluate the performance of Withings SCT02 with embedded Withings ECG-app in the automatic detection of atrial fibrillation
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Male or female who are 22 years of age or older
- •Subject able to read, understand, and provide written informed consent
- •Subject willing and able to participate in the study procedures as described in the consent form
- •Subject able to communicate effectively with and willing to follow instructions from the study staff
排除标准
- •Subject with an implanted electrical device (i.e. pacemaker, ICD …), whether active or inactive
- •Pathologic disorders that may affect motricity resulting in significant hands tremor that prevents subject from being able to hold still (e.g. Parkinson disease)
- •Myocardial Infarction (MI) within 90 days prior to the enrollment
- •Pulmonary embolism or pulmonary infarction within 90 days prior to the enrollment
- •Stroke or Transient Ischemic Attack (TIA) within 90 days prior to the enrollment
- •Active or history of life-threatening rhythms as determined by investigators (e.g. ventricular tachycardia, ventricular fibrillation, 3rd degree heart block)
- •Any cardiovascular disease that investigators would consider as a risk to subject or renders data uninterpretable (e.g. recent or ongoing unstable angina, decompensated heart failure, active myocarditis or pericarditis)
- •Active or symptomatic skin disease on Schiller electrode attachment sites or fingertips which would be in contact with BeamO electrodes (e.g. eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis)
- •Known sensitivity to medical adhesives, isopropyl alcohol,, electrocardiogram (ECG) electrodes, including known allergy or sensitivity to stainless steel (used in BeamO electrodes).
研究组 & 干预措施
Normal Sinus Rhythm
Simultaneous ECG recording of patient with Normal Sinus Rhythm with investigational and reference devices
干预措施: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording (Device)
Normal Sinus Rhythm
Simultaneous ECG recording of patient with Normal Sinus Rhythm with investigational and reference devices
干预措施: Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording (Device)
Atrial Fibrillation
Simultaneous ECG recording of patient with Atrial Fibrillation with investigational and reference devices
干预措施: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording (Device)
Atrial Fibrillation
Simultaneous ECG recording of patient with Atrial Fibrillation with investigational and reference devices
干预措施: Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording (Device)
Arrhythmia other than Atrial Fibrillation
Simultaneous ECG recording of patient with Arrhythmia other than Atrial Fibrillation with investigational and reference devices
干预措施: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording (Device)
Arrhythmia other than Atrial Fibrillation
Simultaneous ECG recording of patient with Arrhythmia other than Atrial Fibrillation with investigational and reference devices
干预措施: Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording (Device)
结局指标
主要结局
Co-primary outcome 2 - Specificity of Investigational Device
时间窗: 10 months
Specificity (percentage of true negatives) in detecting AF from conclusive recordings generated by the software under test, that is recordings resulting in a classification of AF or SR by the IMD, compared to the reference 12-lead ECG.
Co-primary outcome 1 - Sensitivity of Investigational Device
时间窗: 10 months
Sensitivity (percentage of true positives) in detecting AF from conclusive recordings generated by the software under test, that is recordings resulting in a classification of AF or SR by the IMD, compared to the reference 12-lead ECG.
次要结局
- Rhythm classification by ranges of heart rate(10 months)
- Quality of plots measured by the IMD - ECG Waveform Visibility(10 months)
- Quality of plots measured by the IMD - ECG Waveforms Polarity(10 months)
- Quality of plots measured by the IMD - ECG Waveforms Intervals(10 months)
- Quality of plots measured by the IMD - Heart Rate calculation(10 months)