Avidhrt Clinical Equivalence of ECG
试验速览
- 阶段
- 不适用
- 发起方
- Avidhrt Inc.
- 入组人数
- 75
- 主要终点
- Avidhrt Sense ECG equivalency
研究概览
简要总结
The Avidhrt Clinical Equivalence Study will test and evaluate the equivalency between ECG signals acquired simultaneously using the Avidhrt Sense Lead-1 ECG, and an FDA cleared Lead-12 gel ECG. The Avidhrt Clinical Equivalence Study also includes a sub-study. The Avidhrt Sense Human Factors sub-study will evaluate the usability and efficacy of the user-interface of the Avidhrt Sense device.
详细描述
This study will test the clinical equivalency of an Avidhrt Sense acquired Lead-I ECG signal and a Lead-I ECG signal obtained from an FDA cleared 12-lead-ECG gel electrode.The Avidhrt Clinical Equivalence study is comprised of study Arm A and Arm B. In Arm A of this study the population is comprised exclusively of subjects with AF, who will be asked to participate in the Clinical Equivalence Study and in the Human Factors Sub-Study. In Arm B of this study the population will consist of all other subjects (no AF), who will be asked to participate in the Clinical Equivalence Study, with the option to enroll and participate in the Human Factors Sub-Study. This is a prospective, parallel-cohort, non-randomized study using an enriched population.
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
- •Adults ≥ 22 years old at the time of enrollment
- •Capable of giving informed consent
- •Sufficient manual dexterity to capture an ECG using Avidhrt Sense
- •Subjects in the arrhythmia group must have a known history of arrhythmia, and may have an arrhythmia at the time of enrollment based on the screening ECG just before the study recordings are taken.
排除标准
- •Cardiac pacemaker or implantable cardioverter-defibrillator
- •History of a life-threatening rhythm such as ventricular tachycardia or ventricular fibrillation
- •Anti-arrhythmic (rhythm control) medication use (such as amiodarone or flecainide)
- •Subjects in the normal controls group should not have any history of arrhythmia and should not be in arrhythmia at the time of enrollment based on the screening ECG
- •Subjects with tremors who are unable to stably hold the Avidhrt Sense during a recording without movement
结局指标
主要结局
Avidhrt Sense ECG equivalency
时间窗: 12 months
次要结局
未报告次要终点