Post-surgical Aortic Hemodynamics After Aortic Valve Replacement

Valve Heart Disease Clinical Trial

Official title:

Investigation of Post-surgical Aortic Hemodynamics After Aortic Valve Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03347851
• Other study ID #: 2017-1
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Valve Heart Disease

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