Cardiac Performance System Data Collection Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Cardiac Performance System electronic data for Pulmonary Artery Pressure
研究概览
简要总结
Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)
详细描述
Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to provide written informed consent
- •22 years of age or older
- •Referred for cardiac catheterization for reasons including heart failure, evaluation before transplant, pulmonary hypertension, shortness of breath, valvular disease, etc.
排除标准
- •Previous Heart Transplant
- •Presence of Left Ventricular Assist Device
- •Presence of a Holter monitor or any other electrical leads on the chest at the time of sensor placement
- •Surgical scars/wounds/bandages/ports at the site of sensor placement
结局指标
主要结局
Cardiac Performance System electronic data for Pulmonary Artery Pressure
时间窗: 10 minutes before cardiac catheterization procedure
Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.
Pulmonary Artery Catheter electronic data for Pulmonary Artery Pressure
时间窗: 60 minutes during cardiac catheterization procedure
Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.
Cardiac Performance System electronic data for Cardiac Output
时间窗: 10 minutes before cardiac catheterization procedure
Cardiac function metric measurement including Cardiac Output to report in L/m.
Cardiac Performance System electronic data for Pulmonary Capillary Wedge Pressure
时间窗: 10 minutes before cardiac catheterization procedure
Cardiac function metric measurement including Pulmonary Capillary Wedge Pressure to report in mmHg.
Pulmonary Artery Catheter electronic data for Cardiac Output
时间窗: 60 minutes during cardiac catheterization procedure
Cardiac function metric measurement including Cardiac Output to report in L/m.
Pulmonary Artery Catheter electronic data for Pulmonary Capillary Wedge Pressure
时间窗: 60 minutes during cardiac catheterization procedure
Cardiac function metric measurement including Pulmonary Capillary Wedge Pressure to report in mmHg.
Echocardiography electronic data for Ejection Fraction
时间窗: 15 minutes at a time prior to or after Pulmonary Artery Catheter procedure
Cardiac function measurement including left ventricle ejection fraction to report in percentage.
次要结局
未报告次要终点