RECORD-VP: Real-time Evaluation of Cardiac Outpatient Recording Device With VitalPatch RTM
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Successfully detect heart rhythm of the study subjects using VitalConnect platform as a mobile cardiac telemetry unit
研究概览
简要总结
The primary purpose of this study is to evaluate performance and safety of the VitalConnect Platform when used for mobile cardiac telemetry (MCT) or as an independent diagnostic testing facility (IDTF) system during activities of daily living by subjects 18 years or older who have been recommended MCT by their care provider.
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
- 否
入选标准
- •Age 18 years or older;
- •If recommended mobile cardiac telemetry (MCT) by the care provider
- •If instructed, be willing to record information such as daily activities and symptoms
- •Able to speak, read, and write English.
排除标准
- •Have extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed wear sites;
- •Have a known allergy to medical adhesives;
- •Have any potentially life-threatening condition that (for example ventricular tachycardia or ventricular fibrillation), in the opinion of the Investigator, would interfere with their participation in the study.
结局指标
主要结局
Successfully detect heart rhythm of the study subjects using VitalConnect platform as a mobile cardiac telemetry unit
时间窗: Each patient will be monitored for up-to 30 days
Monitor the heart rhythm of the study subjects initially for up to 24 hours and if the monitoring finds the issue that the doctor is looking for, the monitoring will be stopped. In most of the cases, the monitoring can continue for up to 30 days for each study subject
次要结局
未报告次要终点