Investigation of Post-surgical Aortic Hemodynamics After Aortic Valve Replacement
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- CryoLife, Inc.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Downstream flow patterns (helicity and vorticity)
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Downstream flow patterns (helicity and vorticity)
Time Frame: 3 months
MRI data analysis; Helicity and vorticity graded (1-3) by blinded reviewers.
Hinge washout
Time Frame: 3 months
MRI data analysis; Yes/No
Wall shear stress (WSS)
Time Frame: 3 months
MRI data analysis; WSS, the tangential force exerted by blood flow on the vessel wall, measured in the anastomosis regions
Energy loss
Time Frame: 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.
Secondary Outcomes
- 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)