Status:
COMPLETED
Post-surgical Aortic Hemodynamics After Aortic Valve Replacement
Lead Sponsor:
CryoLife, Inc.
Collaborating Sponsors:
Northwestern University
Conditions:
Valve Heart Disease
Eligibility:
All Genders
18-89 years
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 populatio...
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 replace...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 26 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03347851
Start Date
October 26 2017
End Date
June 1 2020
Last Update
March 4 2021
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60208