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Completed

NCT Number: NCT03347851

Post-surgical Aortic Hemodynamics After Aortic Valve Replacement

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.

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Key information

Conditions

Valve Heart Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University

Chicago, Illinois, 60208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Other

Enrolled patients will complete a non-contrast cardiac MRI

Transthoracic echocardiography exam

Other

Enrolled patients will complete a transthoracic echocardiography exam.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

CryoLife, Inc.

Industry

Collaborators

  • Northwestern University

Registry information

Official study title

Investigation of Post-surgical Aortic Hemodynamics After Aortic Valve Replacement

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 20, 2017
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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