Post-surgical Aortic Hemodynamics After Aortic Valve Replacement

CryoLife

Status: Completed

Conditions: Valve Heart Disease

Treatments: Other: Transthoracic echocardiography exam; Other: MRI

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03347851

2017-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

On-X AAP

Description:

Patients with prior AVR surgery with the CryoLife On-X Ascending Aortic Prosthesis (AAP).

Treatment:

Other: Transthoracic echocardiography exam

Other: MRI

SJM Masters or Carbomedics Carbo-seal

Description:

Patients with St. Jude Medical Masters HP Valved Graft with Gelweave Valsalva™ Technology or Carbomedics Carbo-seal (including Carbo-seal Valsalva) mechanical aortic valve prostheses patients

Treatment:

Other: Transthoracic echocardiography exam

Other: MRI