Post-surgical Aortic Hemodynamics After Aortic Valve Replacement

Completed

Conditions studied: Valve Heart Disease

In brief

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.

Key facts

Study ID

NCT03347851

Run by

CryoLife, Inc.

People needed

20

Starts

2017-10-26

Expected to finish

2020-06-01

Last updated by the study team

2021-03-04

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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