Remote Cardiac Monitoring by the Corsano CardioWatch 287-2 Evaluation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Blood pressure accuracy
研究概览
简要总结
In this study, a wristband that monitors hearth rhythm and blood pressure is assessed in free living conditions.
Two groups of patients are being recruited: patients receiving an EKG holter and patients receiving an automatic blood pressure monitor. Patients wear the wristband for 28 days. During this time, the number of atrial fibrillation episodes detected by the wristband is being counted, which is to be compared with the number of episodes detected by the holter. Also, blood pressure is measured continuously, which is to be compared with daily blood pressure measurements using a conventional blood pressure cuff.
详细描述
Background of the study:
Wearables have the potential to monitor patients remotely. The Corsano CardioWatch 287-2 is such a medical device that can monitor atrial fibrillation and long-term blood pressure. The device has been validated using clinical trials in hospitals, but validation in the intended remote setting is lacking.
Objective of the study:
Primary objective: To compare the number of episodes of atrial fibrillation detected by the Corsano CardioWatch 287-2 during 28 days of use with the number of episodes of atrial fibrillation detected by conventional Holter monitoring during 48 hours of use (standard care).
Secondary objective: To assess the difference in blood pressure measurements obtained by the Corsano CardioWatch 287-2 and the conventional cuff blood pressure monitor over a period of 28 days; to assess the usability of the Corsano CardioWatch 287-2 from a patient perspective.
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
- 否
入选标准
- •≥ 18 years old;
- •able to provide consent;
- •receiving EKG holter or automatic blood pressure cuff for home monitoring per doctor prescription
排除标准
- •Unable to wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;
- •Unable to receive blood pressure measurements per cuff due to lymphedema, amputation, dialysis shunt, wounds, etc.;
- •Pregnant women;
- •Breastfeading women;
- •Upper arm circumference not within the cuff range (22-42 cm)
- •Unable or not willing to sign informed consent;
- •Significant mental or cognitive impairment.
结局指标
主要结局
Blood pressure accuracy
时间窗: 28 days (EKG holter group) or 1-2 days (Automatic blood pressure group)
Mean systolic and diastolic blood pressure difference and its SD between blood pressure measured by the Corsano CardioWatch 287-2 and blood pressure measured by a conventional oscillometric blood pressure cuff.
Atrial fibrillation detection rate
时间窗: 28 days
Absolute percentage increase of patients in whom at least one event of atrial fibrillation is detected by the Corsano CardioWatch 287-2 during 28 days of monitoring, compared to a conventional EKG holter during 24-48 hours of monitoring.
次要结局
- Usability questionnaire(28 days (EKG holter group) or 1-2 days (Automatic blood pressure group))
- Blood pressure accuracy(28 days (EKG holter group) or 1-2 days (Automatic blood pressure group))