Study of Validation of the Advanced Blood Pressure Monitor Withings WPM04 for the Detection of Anomalies of Arterial Pressure, Arrhythmia and Valvular Heart Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Withings
- 入组人数
- 218
- 试验地点
- 2
- 主要终点
- AF and SR classification accuracy
研究概览
简要总结
The proposed clinical study aims to validate the effectiveness of the WPM04 blood pressure monitor developed by Withings as a diagnostic tool for cardiovascular disorders.
The detection of cardiovascular disorders is oriented along three axes, namely the measurement of blood pressure, the identification of rhythm disorders such as atrial fibrillation and the identification of heart murmur indicating valvular heart disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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 over 18 years old,
- •Subject who signed the consent form,
- •Subject affiliated to a social security scheme or entitled.
排除标准
- •Underage subject;
- •Subject who refused to participate in the study;
- •Subject participating in other research or clinical studies;
- •Subject with body mass index greater than 35 kg/m2;
- •Subject in linguistic or psychic incapacity to sign an informed consent;
- •Subject with congenital cardiomyopathy;
- •Subject with aorto-venous fistula;
- •Subject with pulmonary pathology that may degrade the quality of the recording;
- •Subject presenting a serious pathology compromising the realization of the examinations envisaged in the test;
- •Subject with an arm injury incompatible with the use of an armband sphygmomanometer;
- •Subject receiving an intravenous perfusion on the left arm;
- •Subject with electrical stimulation by pacemaker, implantable cardioverter-defibrillator;
- •Subject with prosthetic heart valve;
- •Subject under kidney dialysis;
- •Hemodynamically unstable subject (acute heart failure or cardiac assistance).
研究组 & 干预措施
Blood pressure (BP)
Group for the validation of blood pressure measurement by the device
干预措施: BP measurement (Diagnostic Test)
Blood pressure (BP)
Group for the validation of blood pressure measurement by the device
干预措施: VHD detection (Diagnostic Test)
Atrial fibrillation (AF)
Group for the validation of detection of AF by the device
干预措施: AF detection (Diagnostic Test)
Atrial fibrillation (AF)
Group for the validation of detection of AF by the device
干预措施: VHD detection (Diagnostic Test)
Valvular heart disease (VHD)
Group for the validation of detection of VHD by the device
干预措施: BP measurement (Diagnostic Test)
Valvular heart disease (VHD)
Group for the validation of detection of VHD by the device
干预措施: AF detection (Diagnostic Test)
Valvular heart disease (VHD)
Group for the validation of detection of VHD by the device
干预措施: VHD detection (Diagnostic Test)
结局指标
主要结局
AF and SR classification accuracy
时间窗: 1 visit (30 minutes)
sensitivity and specificity of detection of AF and SR from 1-lead ECG against 12-lead ECG
VHD detection accuracy
时间窗: 1 visit (30 minutes)
sensitivity and specificity of detection of VHD from phonocardiogram against Doppler echocardiogram
BP precision and accuracy
时间窗: 1 visit (45 minutes)
mean error and standard deviation on measurements, and standard deviation on patients (criteria 1 and 2 of ANSI/AAMI/ISO 81060-2:2013) against sphygmomanometer dual observer auscultation
次要结局
- safety evaluation(1 visit (1 hour))