NCT03807622已完成不适用
A Prospective, Nonrandomized, Non-interventional Trial to Evaluate ClearSight System Cardiac Output in China
Edwards Lifesciences3 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2018年12月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 3
- 主要终点
- Cardiac Output using the Non-invasive ClearSight System
研究概览
简要总结
The purpose of this clinical trial is to demonstrate that cardiac output (CO) as determined with the Clinical Platform (Model:EV1000A, Software Version:1.9) in a noninvasive manner is comparable to CO as determined by Pulmonary Artery Catheter (PAC) thermodilution (TD). The results of this study may be used for registration and regulatory submissions.
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
- •Subjects must be at least 18 years of age
- •Subjects provide written informed consent prior to trial procedures
- •Subjects' height and weight must be accurately obtained prior to study start.
排除标准
- •Aortic or tricuspid valve regurgitation
- •Aortic stenosis or aneurysms
- •Cardiac rhythm disorder
- •Patients with extreme contraction of the smooth muscle in the arteries and arterioles in the lower arm and hand, such as may be present in patients with Raynaud's or Buerger's disease or with extremely cold hands
- •Inability to place the finger cuff appropriately due to subject anatomy or condition
- •Known pregnancy
- •Patients being treated with an intra-aortic balloon pump
- •Patient is currently participating in an investigational drug or another device study that clinically interferes with the study endpoints
- •Intracardiac shunt
结局指标
主要结局
Cardiac Output using the Non-invasive ClearSight System
时间窗: Expected to last no more than 6 hours
Cardiac Output using the Non-invasive ClearSight System
次要结局
- The percentage error (PE) between the ClearSight System CO and TD(Expected to last no more than 6 hours)
研究者
研究点 (3)
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