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临床试验/NCT05914051
NCT05914051尚未招募不适用

PRELOAD TAVI Trial: Prospective Randomized Trial of Volume Preload Optimization in Patients With Severe Aortic Stenosis Treated on Spontaneous Breathing With Transfemoral TAVI

Fundación de investigación HM0 个研究点目标入组 50 人开始时间: 2023年10月1日最近更新:
适应症

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

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

发起方
Fundación de investigación HM
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leire Unzue Vallejo

PRELOAD-TAVI Trial

Fundación de investigación HM

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