试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- No specified primary endpoint
研究概览
简要总结
The purpose of this investigation is to collect a database of simultaneous electrocardiogram (ECG) recordings from the SANSA device and a reference 12-lead ECG recording device.
The purpose of this database is to aid development and evaluation of algorithms to detect cardiac arrhythmias and other parameters from the electrocardiogram. Example analyses that may utilize this database are ECG vector transformations and ECG waveform timing analyses.
The study is for scientific purposes and does not intend to diagnose, cure, mitigate, treat, or prevent any disease and does not involve any medical procedures.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •are 18 years of age or older.
- •are able to read, understand, and sign informed consent documentation.
- •are willing to undergo simultaneous recordings with the Sansa and 12-lead ECG device.
排除标准
- •exhibit deformities of the chest (e.g., pronounced scarring, pectus carinatum) that would interfere with sensor placement
- •have broken or injured skin that would interfere with sensor placement
- •are known to experience adverse reactions to medical-grade adhesive
- •are pregnant
结局指标
主要结局
No specified primary endpoint
时间窗: Subjects will participate in a single visit. Subjects will be considered enrolled upon signing the informed consent. The entire duration of enrollment is expected to be less than one hour and no more than six hours
This data collection protocol does not have any specific data analysis endpoints. Its purpose is to collect data to be included in an ECG database that may be used for various future analyses. The number, severity, and device/comparator relatedness of AEs reported while subjects undergo study procedures will be reported.
次要结局
未报告次要终点