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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03347851
Study type Observational
Source CryoLife, Inc.
Contact
Status Completed
Phase
Start date October 26, 2017
Completion date June 1, 2020

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