NCT05316337已完成不适用
Validation of WBS08 With Withings ECG Monitor for the Detection of Atrial Fibrillation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Withings
- 入组人数
- 650
- 试验地点
- 20
- 主要终点
- Co-primary outcomes
研究概览
简要总结
The aim of the study is to evaluate the performance of Withings WBS08 with embedded Withings ECG Monitor 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
- 否
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
- •Vulnerable subject with regard to regulations in force
- •Subject who is deprived of liberty by judicial, medical or administrative decision,
- •Underage subject,
- •Legally protected subject, or subject who is unable, linguistic or psychic incapacity, to sign the written informed consent form.
- •Subject within several of the above categories,
- •Subject who refused to participate in the study,
- •Subject mentally impaired resulting in limited ability to cooperate
- •Subject with electrical stimulation by pacemaker
- •Patient with pathologic disorder that may affect motricity resulting in significant tremor that prevents subject from being able to hold still (e.g Parkinson disease)
- •Patient unable to stay in an upright position for the duration of study measures
- •Acute myocardial infarction (MI) within 90 days of screening or other cardiovascular disease that, in the opinion of the Investigator, may increase the risk to the subject or renders data uninterpretable (e.g., recent or ongoing unstable angina, decompensated heart failure, active myocarditis or pericarditis)
- •Acute pulmonary embolism or pulmonary infarction, within 90 days of screening
- •Stroke or transient ischemic attack within 90 days of screening
- •Active life-threatening rhythms as determined by the investigator (ventricular tachycardia, ventricular fibrillation, 3 rd -degree heart block).
- •History of life-threatening rhythms as determined by the investigator (ventricular tachycardia, ventricular fibrillation, 3 rd -degree heart block)
- •Symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis over electrode attachment sites
- •Known sensitivity to medical adhesives, isopropyl alcohol, or electrocardiogram (ECG) electrodes including known allergy or sensitivity to fluoroelastomer bands
- •Weight more than 180 kg
研究组 & 干预措施
Normal Sinus Rhythm
Experimental
干预措施: Electrocardiogram recording (Device)
Atrial fibrillation
Experimental
干预措施: Electrocardiogram recording (Device)
结局指标
主要结局
Co-primary outcomes
时间窗: 4 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 SUT, compared to the reference 12-lead ECG.
次要结局
- Evaluation of the classification into heart rate subgroups(4 months)
- Heart Rate equivalence(4 months)
- Clinical Equivalence of ECG waveforms(4 months)
研究者
研究点 (20)
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