Post-surgical Aortic Hemodynamics After Aortic Valve Replacement

Launched by CRYOLIFE, INC. · Nov 15, 2017

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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