Investigation of Post-surgical Aortic Hemodynamics After Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Downstream flow patterns (helicity and vorticity)
研究概览
简要总结
The purpose of this pilot study is to obtain both near valve and downstream flow characteristics, using 3D transthoracic echocardiography and 4D flow MRI respectively, in an existing patient population at Northwestern Memorial Hospital, to determine the hinge washout characteristics and downstream flow patterns of the On-X valve and compared to competing designs.
详细描述
Prospective, concurrent 4D flow Magnetic Resonance Imaging (MRI) and echocardiography of On-X and St Jude Medical (SJM) Masters HP or Carbomedics Carbo-seal or Carbo-seal Valsalva aortic valve replacement (AVR) patients will be performed. Echocardiography analysis will include: valve function (opening angle), pressure gradients, and degree of valve washout. MRI analysis will focus on downstream flow patterns (helicity and vorticity), energy loss, pressure recovery, and measurement of wall shear stress in the anastomosis regions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects 18-89 years of age
- •Patients with aortic valve disease who within the last five years underwent AVR using the On-X aortic valve, SJM Masters HP, or Carbomedics aortic valves.
排除标准
- •Patients contraindicated against MRI
- •Patients with pacemakers, cochlear (in the ear) implants, or aneurysm clips or patients who have worked with metal
- •Patients unwilling or unable to give written informed consent
- •Pregnant women
- •Prisoners
- •Patients with an Effective Orifice Area index (EOAi) <0.85 cm2/m2
结局指标
主要结局
Downstream flow patterns (helicity and vorticity)
时间窗: 3 months
MRI data analysis; Helicity and vorticity graded (1-3) by blinded reviewers.
Hinge washout
时间窗: 3 months
MRI data analysis; Yes/No
Wall shear stress (WSS)
时间窗: 3 months
MRI data analysis; WSS, the tangential force exerted by blood flow on the vessel wall, measured in the anastomosis regions
Energy loss
时间窗: 3 months
MRI data analysis; Irreversible energy loss quantified.Efforts will include the quantification of turbulent kinetic energy. This is representative of permanent pressure loss.
次要结局
- Ejection Fraction (%)(3 months)
- Normalized ESV (mL/m^2)(3 months)
- Mean transvalvular pressure gradient (mmHg)(3 months)
- Primary ESV (mL)(3 months)
- Mean velocity (m/s)(3 months)
- Normalized EDV (ml/m^2)(3 months)
- Peak transvalvular pressure gradient (mmHg)(3 months)
- Effective Orifice Area (EOA)(3 months)
- Primary EDV (ml)(3 months)
- Peak Velocity (m/s)(3 months)
- Effective Orifice Area index (EOAi)(3 months)