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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03347851
Other study ID # 2017-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 26, 2017
Est. completion date June 1, 2020

Study information

Verified date March 2021
Source CryoLife, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 1, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
MRI
Enrolled patients will complete a non-contrast cardiac MRI
Transthoracic echocardiography exam
Enrolled patients will complete a transthoracic echocardiography exam.

Locations

Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
CryoLife, Inc. Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Downstream flow patterns (helicity and vorticity) MRI data analysis; Helicity and vorticity graded (1-3) by blinded reviewers. 3 months
Primary Hinge washout MRI data analysis; Yes/No 3 months
Primary Energy loss MRI data analysis; Irreversible energy loss quantified.Efforts will include the quantification of turbulent kinetic energy. This is representative of permanent pressure loss. 3 months
Primary Wall shear stress (WSS) MRI data analysis; WSS, the tangential force exerted by blood flow on the vessel wall, measured in the anastomosis regions 3 months
Secondary Ejection Fraction (%) 3 months
Secondary Primary EDV (ml) End Diastolic Volume 3 months
Secondary Normalized EDV (ml/m^2) End Diastolic Volume 3 months
Secondary Primary ESV (mL) End Systolic Volume 3 months
Secondary Normalized ESV (mL/m^2) End Systolic Volume 3 months
Secondary Peak Velocity (m/s) 3 months
Secondary Mean velocity (m/s) 3 months
Secondary Peak transvalvular pressure gradient (mmHg) 3 months
Secondary Mean transvalvular pressure gradient (mmHg) 3 months
Secondary Effective Orifice Area (EOA) 3 months
Secondary Effective Orifice Area index (EOAi) 3 months
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