NCT03347851

Post-surgical Aortic Hemodynamics After Aortic Valve Replacement

Investigation of Post-surgical Aortic Hemodynamics After Aortic Valve Replacement

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: CryoLife, Inc. · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Valve Heart Disease

Interventions

Type	Name	Description
OTHER	MRI	Enrolled patients will complete a non-contrast cardiac MRI
OTHER	Transthoracic echocardiography exam	Enrolled patients will complete a transthoracic echocardiography exam.

Timeline

• Start date: 2017-10-26
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2017-11-20
• Last updated: 2021-03-04

Locations

1 site across 1 country: United States