Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work.
研究概览
简要总结
The primary objective of this study is to develop normative hemodynamic data (means and standard deviations) for the intra-aortic balloon pump (IABP) using pressure-volume loop and 3D-echocardiographic analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or females between 18-75 years of age
- •NYHA Class III-IV heart failure at the time of MEGA deployment
- •Stage C-D systolic heart failure
- •Non-ischemic cardiomyopathy
- •Preserved right ventricular function defined by 2D-echocardiography
- •Clinically indicated left and right heart catheterization and MEGA-IABP placement
- •Clinically indicated MEGA-IABP support for 12 hours minimum
排除标准
- •Ischemic cardiomyopathy
- •Active myocardial ischemia or acute coronary syndrome
- •Severe peripheral vascular disease
- •Severe aortic or mitral valve insufficiency
- •Severe aortic or mitral valve stenosis
- •Right ventricular failure
- •Inability to tolerate left and right heart catheterization
- •Severe hemodynamic instability defined as a systolic BP <80mmHg despite vasopressor/inotropic support
- •Sustained ventricular tachycardia (>10 beats) within 24 hours and/or ventricular fibrillation within 24 hours
- •Pacemaker dependent rhythm
- •Left ventricular thrombus
- •Rapid atrial fibrillation (HR>120 bpm)
- •Unable to provide informed consent
- •Pregnancy
研究组 & 干预措施
IABP recipient
Referred for clinically indicated right heart catheterization with intervention of IABP placement prior to LVAD surgery.
干预措施: Conductance catheterization (Device)
Control
Control subjects undergoing left heart catheterization with an LV ejection fraction > 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.
干预措施: Conductance catheterization (Device)
结局指标
主要结局
Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work.
时间窗: 24 hours
We will be measuring left ventricular stroke work using a conductance catheter before and immediately after activation of an intra-aortic balloon pump (IABP). Left ventricular stroke work is quantified as the product of left ventricular pressure and volume. Conductance catheters are the primary method available for clinical measurement of left ventricular volume and pressure.
次要结局
未报告次要终点