NCT05316350已完成不适用
Validation of HWA10 With Withings ECG-app 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
- 685
- 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 HWA10 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
- 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
- •Have a wrist circumference between 140 mm and 210 mm (measured at "band center" on the preferred wrist, 1cm from the bone. This location is determined by asking the volunteer to put on a normal wrist-watch and marking the skin with a pen/marker to outline the edges of the band.)
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 in physical incapacity to wear a watch on one wrist and place the other hand on top of the watch
- •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)
- •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 abnormal life-threatening rhythms (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 on both wrists or over electrode attachment sites
- •Known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or electrocardiogram (ECG) electrodes including known allergy or sensitivity to fluoroelastomer bands primarily used in wrist worn fitness devices
研究组 & 干预措施
Atrial Fibrillation
Experimental
干预措施: Electrocardiogram recording (Device)
Normal Sinus Rhythm
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
- Heart Rate equivalence(4 months)
- Evaluation of the classification into heart rate subgroups(4 months)
- Clinical Equivalence of ECG waveforms(4 months)
研究者
研究点 (20)
Loading locations...
相似试验
已完成
不适用
WIBOFA - Validation of SCT02 With ECG-App for Detection of AFAtrial FibrillationNCT06351761Withings373
已完成
不适用
Withings ECG-Monitor StudyAtrial FibrillationNCT05316337Withings650
已完成
不适用
Clinical Validation of the Withings ECG Monitor for the Detection of Atrial FibrillationAtrial FibrillationNCT05266235Withings274
已完成
不适用
Validation Study of the Watch HWA09 and Its Softwares ECG-SW1 and PPG-SW1 for the Detection of Atrial FibrillationArrythmia, CardiacAtrial FibrillationNCT04351386Withings283
已完成
不适用
Validation Study of a Watch for the Detection of Atrial FibrillationArrythmia, CardiacAtrial FibrillationNCT04041466Withings140