NCT02099448已完成不适用
Correlation of Non-invasive Assessment, Using C.A 2.0 Device, Versus Invasive Assessment of Left Ventricular End Diastolic Pressure (LVEDP)
CorAlert Ltd.1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2014年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Establish the accuracy of the non-invasive device, C.A 2.0, to estimate LVEDP comparing it to the invasive hemodynamic measurement via left heart catheterization
研究概览
简要总结
The purpose of the study is to determine the accuracy of non-invasive assessment of LVEDP using the investigational device C.A 2.0.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male subject between the ages of 18 - 80 years or postmenopausal female up to 80 years of age
- •Patient undergoing elective cardiac catheterization during which LVED and aortic pressures are recorded
- •Willing and able to sign informed consent prior to study initiation
排除标准
- •Subject has a baseline heart rate of < 60 or >100 beats/min
- •Subject has moderate to severe valvular disease
- •Subject suffers from atrial fibrillation or other tachyarrhythmias
- •Subject suffers from hemodynamic instability
- •Subject is candidate for primary PCI
结局指标
主要结局
Establish the accuracy of the non-invasive device, C.A 2.0, to estimate LVEDP comparing it to the invasive hemodynamic measurement via left heart catheterization
时间窗: During elective cardiac catheterization
次要结局
未报告次要终点
研究者
研究点 (1)
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