PRELOAD TAVI Trial: Prospective Randomized Trial of Volume Preload Optimization in Patients With Severe Aortic Stenosis Treated on Spontaneous Breathing With Transfemoral TAVI
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Cardiac output after valve implant
研究概览
简要总结
The aim is to assess the response of cardiac output and stroke volume to volume preload optimization in patients with severe aortic stenosis treated with aortic prosthesis implantation.
详细描述
Patients with severe aortic stenosis present a maintained overload pressure of the left ventricle that can lead to a progressive hypertrophy. This results in elevated left-sided filling pressures and impaired diastolic function.In this context, paradoxical changes in left ventricular function after aortic valve replacement have been described, with acute decrease of the afterload condition that can result in the development of a dynamic intraventricular gradient, especially in the presence of small ventricles with severe hypertrophy, resulting in hemodynamic collapse.
In this setting, it is particularly important to ensure accurate left ventricular preload to optimize myocardial contractility and guarantee an adequate hemodynamic response to valve implantation.
Patients with severe aortic stenosis submitted for transfemoral TAVI on spontaneous breathing will be randomly assigned 1:1 to standard care vs volume preload optimization. Non-invasive continuous monitoring (Clear Sight System, Edwards Lifesciences) will be used to evaluate the cardiac output and the stroke volume in both groups, comparing the hemodynamics before and after valve implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 110 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aortic valve stenosis with echocardiographic derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or an initial aortic valve area of < 0.8 cm2
排除标准
- •Cardiogenic shock.
- •Life expectancy < 1 year.
- •Need of mechanic ventilation.
结局指标
主要结局
Cardiac output after valve implant
时间窗: "1 year"
Cardiac output (l/min) after TAVI
次要结局
- Stroke volume after valve implant("1 year")
研究者
Leire Unzue Vallejo
PRELOAD-TAVI Trial
Fundación de investigación HM
