Post-surgical Aortic Hemodynamics After Aortic Valve Replacement

Completed

• Conditions: Valve Heart Disease

• Registration Number: NCT03347851
• Lead Sponsor: CryoLife, Inc.

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.

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 Timeline

• Study First Submitted: 2017-10-24
• Study Start: 2017-10-26
• Study First Submitted QC: 2017-11-15
• Study First Posted: 2017-11-20
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-03
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Downstream flow patterns (helicity and vorticity)	3 months	MRI data analysis; Helicity and vorticity graded (1-3) by blinded reviewers.
Hinge washout	3 months	MRI data analysis; Yes/No
Wall shear stress (WSS)	3 months	MRI data analysis; WSS, the tangential force exerted by blood flow on the vessel wall, measured in the anastomosis regions
Energy loss	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.

Secondary Outcome Measures

Name	Time	Method
Ejection Fraction (%)	3 months
Normalized ESV (mL/m^2)	3 months	End Systolic Volume
Mean transvalvular pressure gradient (mmHg)	3 months
Primary ESV (mL)	3 months	End Systolic Volume
Mean velocity (m/s)	3 months
Normalized EDV (ml/m^2)	3 months	End Diastolic Volume
Peak transvalvular pressure gradient (mmHg)	3 months
Effective Orifice Area (EOA)	3 months
Primary EDV (ml)	3 months	End Diastolic Volume
Effective Orifice Area index (EOAi)	3 months
Peak Velocity (m/s)	3 months

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States