Post-surgical Aortic Hemodynamics After Aortic Valve Replacement

NCT03347851 | Completed

• 1 other identifier: 2017-1
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Valve Heart Disease

Keywords

mechanical heart valve; On-X

Outcome Measures

Primary Outcomes (4)

• Downstream flow patterns (helicity and vorticity)

  MRI data analysis; Helicity and vorticity graded (1-3) by blinded reviewers.

  3 months

• Hinge washout

  MRI data analysis; Yes/No

  3 months

• 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

• 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 Outcomes (11)

• Ejection Fraction (%)

  3 months

• Primary EDV (ml)

  3 months

• Normalized EDV (ml/m^2)

  3 months

• Primary ESV (mL)

  3 months

• Normalized ESV (mL/m^2)

  3 months

Study Arms (2)

On-X AAP

Patients with prior AVR surgery with the CryoLife On-X Ascending Aortic Prosthesis (AAP).

Other: MRI; Other: 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; Other: Transthoracic echocardiography exam

Interventions

MRI OTHER

Enrolled patients will complete a non-contrast cardiac MRI

On-X AAP; SJM Masters or Carbomedics Carbo-seal

Transthoracic echocardiography exam OTHER

Enrolled patients will complete a transthoracic echocardiography exam.

On-X AAP; SJM Masters or Carbomedics Carbo-seal

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CryoLife, Inc.: lead
• Northwestern University: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60208, United States

Location

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 20, 2017
• Study Start: October 26, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: March 4, 2021

Record last verified: 2021-03

Locations

US (1)