Collection of ECG Recordings Using the HeartBeam 3-Lead ECG Recorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Creation of a de-identified ECG dataset for future research and regulatory use
研究概览
简要总结
The HeartBeam ECG Registry will collect ECG recordings acquired with the HeartBeam System with relevant clinical information in clinical settings.
详细描述
This study aims to collect electrocardiogram (ECG) recordings using the HeartBeam System across a broad range of cardiac conditions and patient populations. Data collection will include various rhythm types (e.g., sinus rhythm, atrial fibrillation, atrial flutter, ectopic beats, and other non-life-threatening arrhythmias), conduction disorders, and heart rate abnormalities (including bradycardia and tachycardia). The study will also ensure representation across diverse patient subgroups defined by race, ethnicity, age, sex, body mass index (BMI), and comorbidities.
A de-identified ECG database will be established from the collected data to support future research and regulatory activities, including evaluation of device performance across different rhythm types and patient subpopulations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Undergoing ECG as part of standard of care.
- •Able and willing to provide written informed consent.
排除标准
- •Open chest wounds or surgery to the chest or abdomen within 30 days.
- •Inability to complete ECG acquisition with either HeartBeam device or standard 12-L ECG.
- •Unstable condition where registry participation may interfere with care.
结局指标
主要结局
Creation of a de-identified ECG dataset for future research and regulatory use
时间窗: 2 years
ECG recordings collected during the study will be de-identified and compiled into a database that may be used by HeartBeam for future research and regulatory submissions. The collected data are for observational purposes only and will not be used for clinical decision-making.
次要结局
未报告次要终点