NCT04338503招募中不适用
Mechanically Optimizing Cardiac Preload Using Partial Inferior Vena Cava Occlusion to Reduce Pulmonary Pressures in Heart Failure Patients in Heart Failure Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in pulmonary arterial pressures
研究概览
简要总结
The purpose of the current study is to determine if partial balloon occlusion of the inferior vena cava can optimize cardiac pre-load and subsequently pulmonary pressures and cardiac output as a novel method to unload pulmonary edema and other symptoms of decompensated congestive heart failure. All products in this study are FDA approved and adhere to the specifications of the intended use.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects scheduled to undergo a right heart catheterization at Saint Thomas Hospital.
- •New York Heart Association (NYHA) II or III.
- •Subjects must be last least 18 years of age.
- •A left ventricular ejection fraction >= 20%.
- •Pulmonary artery occlusion pressure, or pulmonary wedge pressure >20 mmHg.
排除标准
- •Subjects without sinus rhythm.
- •Evidence of right heart failure.
- •Patients with primary pulmonary hypertension
- •Pulmonary wedge pressure <15mmHg.
- •Significant lung disease, such as prior diagnosis of COPD.
- •Resting or dynamic outflow tract gradient
- •Patients with left bundle branch block
结局指标
主要结局
Change in pulmonary arterial pressures
时间窗: During partial balloon occlusion
Change in the measured mean pulmonary arterial pressure
次要结局
- Change in cardiac output(During partial balloon occlusion)
研究者
研究点 (1)
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