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Post-surgical Aortic Hemodynamics After Aortic Valve Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03347851
Recruitment Status : Completed
First Posted : November 20, 2017
Last Update Posted : March 4, 2021
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
CryoLife ( CryoLife, Inc. )

Study Description
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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.

Condition or disease Intervention/treatment
Valve Heart Disease Other: MRI Other: Transthoracic echocardiography exam

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
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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Investigation of Post-surgical Aortic Hemodynamics After Aortic Valve Replacement
Actual Study Start Date : October 26, 2017
Actual Primary Completion Date : June 1, 2020
Actual Study Completion Date : June 1, 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
On-X AAP
Patients with prior AVR surgery with the CryoLife On-X Ascending Aortic Prosthesis (AAP).
 Other: MRI
Enrolled patients will complete a non-contrast cardiac MRI

Other: Transthoracic echocardiography exam
Enrolled patients will complete a transthoracic echocardiography exam.
SJM Masters or Carbomedics Carbo-seal
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
 Other: MRI
Enrolled patients will complete a non-contrast cardiac MRI

Other: Transthoracic echocardiography exam
Enrolled patients will complete a transthoracic echocardiography exam.


Outcome Measures
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Primary Outcome Measures :
  1. Downstream flow patterns (helicity and vorticity) [ Time Frame: 3 months ]
    MRI data analysis; Helicity and vorticity graded (1-3) by blinded reviewers.

  2. Hinge washout [ Time Frame: 3 months ]
    MRI data analysis; Yes/No

  3. 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.

  4. 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


Secondary Outcome Measures :
  1. Ejection Fraction (%) [ Time Frame: 3 months ]
  2. Primary EDV (ml) [ Time Frame: 3 months ]
    End Diastolic Volume

  3. Normalized EDV (ml/m^2) [ Time Frame: 3 months ]
    End Diastolic Volume

  4. Primary ESV (mL) [ Time Frame: 3 months ]
    End Systolic Volume

  5. Normalized ESV (mL/m^2) [ Time Frame: 3 months ]
    End Systolic Volume

  6. Peak Velocity (m/s) [ Time Frame: 3 months ]
  7. Mean velocity (m/s) [ Time Frame: 3 months ]
  8. Peak transvalvular pressure gradient (mmHg) [ Time Frame: 3 months ]
  9. Mean transvalvular pressure gradient (mmHg) [ Time Frame: 3 months ]
  10. Effective Orifice Area (EOA) [ Time Frame: 3 months ]
  11. Effective Orifice Area index (EOAi) [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347851


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60208
Sponsors and Collaborators
CryoLife, Inc.
Northwestern University
More Information
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Responsible Party: CryoLife, Inc.
ClinicalTrials.gov Identifier: NCT03347851    
Other Study ID Numbers: 2017-1
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CryoLife ( CryoLife, Inc. ):
mechanical heart valve
On-X
Additional relevant MeSH terms:
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Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases