Exercise Tolerance in Patients With Implanted Left Ventricular Assist Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Echocardiographic appraisal of aortic valve opening during cycle ergometer exercise.
研究概览
简要总结
To evaluate the concept of dynamic pump speed optimization based on the echocardiographic assessment of aortic valve opening during cardiopulmonary exercise test.
详细描述
Left ventricular assist devices (LVAD) are becoming a destination therapy in patients with end-stage left ventricular dysfunction. Current generation pumps operate with a fixed rotation speed without the capability of automated speed adjustment. It was shown that acceleration of the pump speed during stress test increases the maximum exercise tolerance. Periodic aortic valve opening (AVO) is used to set up an optimal resting pump speed. The study aimed to evaluate the concept of dynamic pump speed optimization based on the echocardiographic assessment of AVO during the cardiopulmonary exercise test (CPET).
Patients with implanted third-generation LVADs with hydrodynamic bearing (HVAD, Medtronic, MN, USA) are prospectively enrolled. Two CPETs are performed after resting speed optimization. The first one with maintained baseline pump speed settings, and the second one with gradually increased speed depending on live echocardiographic imaging. The sequence of tests is random.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients with implanted cardioverter-defibrillator and third-generation centrifugal CF-LVAD with hydrodynamic bearing (HVAD, Medtronic, Minnesota, United States), at least three months after surgery.
排除标准
- •Hemodynamic instability.
- •Non-therapeutic anticoagulation.
- •Device or intracardiac thrombus.
- •Inflammation.
- •Active bleeding.
结局指标
主要结局
Echocardiographic appraisal of aortic valve opening during cycle ergometer exercise.
时间窗: Immediately, during cycle ergometer exercise
Assessment of aortic valve opening during cycle ergometer exercise in LVAD patients.
次要结局
- Change in oxygen consumption(Immediately, during cycle ergometer exercise)
- Change in perceived exertion(Immediately, during cycle ergometer exercise)
- Change in pump speed(Immediately, during cycle ergometer exercise.)
- Change in pump flow(Immediately, during cycle ergometer exercise)
- Change in pump power(Immediately, during cycle ergometer exercise)
研究者
Karol Wierzbicki
Head of Cardiac Transplantation and Mechanical Circulatory Support Unit
John Paul II Hospital, Krakow