Validation Study of WITHINGS BPM Core for the Detection of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Withings
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Sensitivity of the automatic classification in AF by BPM Core single-lead ECG against reference 12-lead ECG
研究概览
简要总结
The proposed clinical study aims to validate the diagnostic performance, compared to a reference ECG, of the electrocardiographic function of the BPM Core developed by Withings for the automatic identification of atrial fibrillation (AF).
详细描述
BPM Core is a blood-pressure monitor with an build-in single-channel electrocardiogram similar to a lead I.
Primary objective:
The primary objective is to demonstrate that Withings BPM Core has acceptable sensitivity and specificity in the automatic identification of AF and SR in comparison with a gold-standard diagnosis from a 12-lead ECG by board certified cardiologists.
The algorithm classifies the device signals into four categories: normal sinus rhythm (RSN), AF, arrhythmia other than AF, or non-interpretable. The latter category includes signals of insufficient quality to be interpreted with confidence.
This classification will be compared to the diagnosis made by three independent, blinded cardiologists based on a 12-lead ECG. The final diagnosis retained will be decided by majority with adjudication by a consensus of 3 to 6 cardiologists. The sensitivity and specificity of the device will then be estimated.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female who are 18 years or older
- •Subject who signed the written informed consent form,
- •Able to communicate effectively with and follow instructions from the study staff
- •Person with an arm circumference between 22 and 42 cm
排除标准
- •Vulnerable subject with regard to regulations
- •Pregnant, parturient or breastfeeding woman,
- •Subject who is deprived of liberty by judicial, medical or administrative decision,
- •Underage subject,
- •Legally protected subject, or subject who is unable to sign the written informed consent form,
- •Subject who is not beneficiary or not affiliated to a social security scheme,
- •Subject within several of the above categories,
- •Subject who refused to participate in the study,
- •Subject in linguistic or psychic incapacity to sign a written informed consent form,
- •Subject in physical incapacity to wear a blood pressure monitor
- •Subject with electrical stimulation by pacemaker
- •Significant tremor that prevents subject from being able to hold still
- •Known sensitivity to medical adhesives, isopropyl alcohol, or ECG electrodes
研究组 & 干预措施
atrial fibrillation (AF)
Patients diagnosed with AF during reference ECG
干预措施: ECG measurement (Diagnostic Test)
sinus rhythm (SR)
Patients diagnosed with SR during reference ECG
干预措施: ECG measurement (Diagnostic Test)
结局指标
主要结局
Sensitivity of the automatic classification in AF by BPM Core single-lead ECG against reference 12-lead ECG
时间窗: 1 year
sensitivity from the 2x2 confusion matrix AF vs 'non-AF'
次要结局
- Sensitivity of the cardiologists' classification in SR from the BPM Core ECG(1 year)
- Accuracy of the positivity of P-waves of single-lead ECG from BPM Core(1 year)
- Sensitivity of the cardiologists' classification in AF from the BPM Core ECG(1 year)
- Accuracy of the visibility of QRS-complexes of single-lead ECG from BPM Core(1 year)
- Accuracy of the positivity of QRS-complexes of single-lead ECG from BPM Core(1 year)
- Accuracy of the visibility of T-waves of single-lead ECG from BPM Core(1 year)
- Accuracy of the visibility of P-waves of single-lead ECG from BPM Core(1 year)
- Accuracy of the positivity of T-waves of single-lead ECG from BPM Core(1 year)