Electrocardiogram Clinical Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 568
- 试验地点
- 6
- 主要终点
- Specificity of rhythm classification
研究概览
简要总结
The purpose of the study is to confirm the Garmin ECG (electrocardiogram) software algorithm can detect and classify atrial fibrillation and normal sinus rhythm on single lead ECG data derived from a Garmin wrist-worn, consumer device. The study will also confirm the software's ability to create a Lead I ECG that is clinically equivalent to a reference device. The Garmin ECG software is not a diagnostic system and is intended for informational purposes only.
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
- •Able to read, understand, and provide written informed consent;
- •Willing and able to participate in the study procedures as described in the consent form;
- •Individuals who are 22 years of age and older;
- •Able to communicate effectively with and follow instructions from the study staff;
- •Have a wrist circumference that fits within the device band; and
- •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 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, including known allergy or sensitivity to silicone bands primarily used in wrist-worn fitness devices;
- •Known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or ECG electrodes;
- •A history of abnormal life-threatening rhythms as determined by the Investigator;
- •Significant tremor that prevents subject from being able to hold still;
- •Women who are pregnant at the time of study participation; and
- •Subjects enrolled into the SR population must not have any diagnosis of AF.
研究组 & 干预措施
Atrial fibrillation (AF)
Patients with a known history of AF who are in AF at the time of study screening.
干预措施: Electrocardiogram (Diagnostic Test)
Normal Sinus Rhythm (SR)
Patients with no known diagnosis of AF or other arrhythmia
干预措施: Electrocardiogram (Diagnostic Test)
结局指标
主要结局
Specificity of rhythm classification
时间窗: 1 Day
Number of participants with a SR software rhythm classification in agreement with a physician's interpretation of heart rhythm based on gold standard 12-lead ECG
Sensitivity of rhythm classification
时间窗: 1 Day
Number of participants with an AF software rhythm classification in agreement with a physician's interpretation of heart rhythm based on gold standard 12-lead ECG
次要结局
- Number of ECGs that pass a visual overlay(Day 1)
- Difference in R-wave amplitudes between the software and gold standard reference(Day 1)