Electrocardiogram Clinical Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Apple Inc.
- 入组人数
- 602
- 试验地点
- 5
- 主要终点
- Number of Participants With Software's Rhythm Classification of SR in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG
研究概览
简要总结
The purpose of the study is to confirm the software's ability to create a Lead-1 electrocardiogram (ECG) that is clinically equivalent to a reference device. Also, to confirm a rhythm classification algorithm and its ability to detect and classify heart rhythms into two categories (Sinus Rhythm or Atrial Fibrillation) using a single Lead ECG.
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
- 是
入选标准
- •Individuals who are 22 years of age and older
- •Able to read, understand, and provide written informed consent
- •Willing and able to participate in the study procedures as described in the consent
- •Have a wrist circumference that fits within the band
- •Able to communicate effectively with and follow instructions from the study staff
- •For subjects enrolled into the AF population, subjects must have a known diagnosis of AF and be in AF at the time of screening
排除标准
- •Physical disability that precludes safe and adequate testing
- •Mental impairment resulting in limited ability to cooperate
- •Subjects with a pacemaker or implantable cardioverter-defibrillator (ICD)
- •Acute myocardial infarction (MI) within 90 days of screening or other cardiovascular disease that, in the opinion of the Investigator, increases the risk to the subject or renders data uninterpretable
- •Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis within 90 days of screening
- •Stroke or transient ischemic attack within 90 days of screening
- •Subjects taking rhythm control drugs
- •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
- •A history of abnormal life-threatening rhythms as determined by the investigator
- •Significant tremor that prevents subject from being able to hold still
- •Pregnant women: Women who are pregnant at the time of study participation
- •For subjects enrolled into the sinus rhythm population, they must not have any diagnosis of AF
研究组 & 干预措施
Atrial fibrillation (AF)
Patient with a known history of AF who are in AF at the time of study screening.
干预措施: 12-Lead ECG (Device)
Atrial fibrillation (AF)
Patient with a known history of AF who are in AF at the time of study screening.
干预措施: 1-Lead ECG (Other)
Normal Sinus Rhythm (SR)
Patient with no known diagnosis of AF or other arrhythmia
干预措施: 1-Lead ECG (Other)
Normal Sinus Rhythm (SR)
Patient with no known diagnosis of AF or other arrhythmia
干预措施: 12-Lead ECG (Device)
结局指标
主要结局
Number of Participants With Software's Rhythm Classification of SR in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG
时间窗: 1 Day
Specificity of rhythm classification
Number of Participants With Software's Rhythm Classification of AF in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG
时间窗: 1 Day
Sensitivity of rhythm classification
次要结局
- Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference(1 Day)
- Ease of Use(1 Day)