Pivotal Method-Comparison Study for the Cardiac Performance System (CPS) to Measure Hemodynamic Parameters
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 20
- 主要终点
- Cardiac Performance System electronic data for Pulmonary Pressure
研究概览
简要总结
This multi-center, observational study evaluates the accuracy of the Cardiac Performance System (CPS), a non-invasive device, for measuring hemodynamic parameters in adult patients undergoing clinically indicated right heart catheterization. The study compares CPS measurements to invasive measurements to assess agreement and potential clinical utility.
详细描述
The study will enroll adults undergoing right heart catheterization as part of their clinical care. A single CPS measurement will be performed before the scheduled procedure. Data from both CPS and catheterization measurements will be analyzed to assess agreement. No investigational treatment or additional follow-up visits are required.
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
- •Adults aged 18 years or older
- •Scheduled for clinically indicated right heart catheterization
- •Ability to provide informed consent
排除标准
- •Heart transplant recipients
- •Patients with a left ventricular assist device (LVAD)
- •Presence of external devices (e.g., Holter monitors) or surgical scars/wounds that interfere with CPS measurements
- •Measurement concerns related to data reliability or quality
研究组 & 干预措施
CPS Measurement Group
Participants undergoing clinically indicated right heart catheterization will receive a single, non-invasive measurement using the Cardiac Performance System (CPS) before their scheduled procedure. The study aims to compare CPS results with standard invasive hemodynamic measurements.
干预措施: Cardiac Performance System (CPS) (Device)
结局指标
主要结局
Cardiac Performance System electronic data for Pulmonary Pressure
时间窗: Single measurement prior to right heart catheterization
Cardiac function metric measurement including Pulmonary Pressure measured in mmHg
Pulmonary artery catheter electronic data for Pulmonary Pressure
时间窗: During right heart catheterization procedure
Cardiac function metric measurement including Pulmonary Pressure measured in mmHg
次要结局
未报告次要终点