Post-surgical Aortic Hemodynamics After Aortic Valve Replacement



Status:Enrolling by invitation
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 89
Updated:12/6/2017
Start Date:October 26, 2017
End Date:August 2018

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Investigation of Post-surgical Aortic Hemodynamics After Aortic Valve Replacement

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.

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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
We found this trial at
1
site
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
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