Clinical Performance of the AFGen1 Device Over a 7-day Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Adhesive performance
研究概览
简要总结
AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib. The purpose of this study is to establish the clinical performance of AFGen1 on human participants.
详细描述
The primary purpose of this study is to demonstrate the ECG signal acquired by the AFGen1 device is of adequate quality and is suitable to support its intended use for the detection of Afib. This will be evaluated by comparing the ECG data acquired by AFGen1 to that acquired by an FDA cleared 12-lead ECG device. The study will also seek to demonstrate that there is no degradation in the quality of the ECG signal it acquires over the maximum 7-day wear period that it can be prescribed for use.
The secondary purpose of this study is to confirm the adhesive performance of the device is appropriate to support its intended use per the requirements of sections 4.4 and 5.4 of ANSI AAMI EC12-1 .
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18+ willing to sign the consent form
排除标准
- •Implanted pacemakers
- •Implanted cardioverter defibrillators
- •Implanted cardiac resynchronization devices
- •Potential life-threatening arrythmias
- •Physical or mental health conditions that would prevent the person from being able to follow instructions regarding participation in the study
- •Open wounds, abraded or irritated skin at the application site
- •Planned to undergo a MRI during the course of the study duration
- •Known or suspected to be pregnant
- •Student or employee of TriVirum
结局指标
主要结局
Adhesive performance
时间窗: 7 days
For the adhesive performance element of the study, the overall average wear time for the device must be greater than 5-days.
Quantitative Evaluation
时间窗: 7 days
For the quantitative evaluation of the mean and standard deviation of the QRS amplitude, duration, and timing correlations for all study subjects and for the end of the wear period for those relevant subjects, the mean correlation coefficient must be greater than 0.95 and standard deviation must be less than 0.05 to validate a 95% confidence interval with significant factor of assurance. validate a 95% confidence interval with significant factor of assurance.
次要结局
未报告次要终点