Correlation of Electrocardiographic Signals Acquired by a Finger-worn ECG Sensor With a Standard 12-Lead ECG
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- R-wave Amplitude
研究概览
简要总结
This study is a cross-sectional observational study conducted in patients referred for routine ECG, to compare output from the everbeat finger-worn ECG device to standard of care (SOC) 12-lead electrocardiography. No intervention is involved in this study. Patients visiting the study site during the study period will be assessed for eligibility on a convenience basis, and observational data will be recorded on those eligible.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Males or females aged 18 to 90 years.
- •Under the care of a board-certified physician and referred for a routine electrocardiogram (ECG)
- •Resting heart rate between 50 to 120 beats per minute (BPM).
排除标准
- •Inability to wear the everbeat ring.
- •Prior history of movement disorders including Parkinson's or benign tremors.
- •Prior history of allergic skin reactions to metal including stainless steel.
结局指标
主要结局
R-wave Amplitude
时间窗: 50 days
R Peak Amplitude intraclass correlation coefficient between test and reference devices in mm
ST-segment
时间窗: 50 Days
Concordance in ST-segment deviation from the TP segment if present in mm
Blinded Cardiologist Review
时间窗: 50 Days
Identify the first six consecutive distinct readable PQRST complexes without artifacts that match between the strips for evaluation. Each reviewer will assign a pass/fail to the strips by visually assessing all 6 PQRST complexes. A "pass" is given when the morphology of the PQRST complexes appears to overlay to the unaided eye. A measurement of the R amplitude from the isoelectric baseline to the nearest millimeter for the first two QRS complexes in both the reference strip and everbeat strip. The reviewers will be blinded to the identity of the reference strip and everbeat strip.
次要结局
- User acceptance survey(50 days)