NCT05266235已完成不适用
Clinical Validation of the Withings ECG Monitor for the Detection of Atrial Fibrillation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Withings
- 入组人数
- 274
- 试验地点
- 8
- 主要终点
- Performance in the identification of atrial fibrillation and sinus rhythm
研究概览
简要总结
The aim of the study is to demonstrate the performance of Withings WBS08 in the automatic identification of atrial fibrillation and sinus rhythm.
详细描述
Patients included will be those presenting for consultation in the various participating clinical services. For each patient, an ECG will be recorded with the WBS08 and with the reference device Cardiovit FT1, at rest and after an exercise session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Male or female who are 18 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
- •Subject affiliated to a social security system
- •For subjects enrolled into the AF population, subjects must have a known diagnosis of AF and be in AF at the time of screening. Subjects may have any type of AF including paroxysmal, persistent, and permanent AF.
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 a pacemaker, ICD (Implantable cardioverter defibrillator) or other implanted electronic stimulator
- •Patient with pathologic disorder that may affect motricity resulting in significant tremor that prevents subject from being ablle 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, 3rd degree heart block).
- •History of abnormal life-threatening rhythms as determined by the investigator (e.g., ventricular tachycardia, ventricular fibrillation, 3rd 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
结局指标
主要结局
Performance in the identification of atrial fibrillation and sinus rhythm
时间窗: 10 months
The co-primary endpoints are the sensitivity and specificity 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(10 months)
- Determination of the heart rate(10 months)
- Assessment of the clinical equivalence of ECG waveforms(10 months)
研究者
研究点 (8)
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