Post-surgical Aortic Hemodynamics After Aortic Valve Replacement
- Conditions
- Valve Heart Disease
- Interventions
- Other: MRIOther: Transthoracic echocardiography exam
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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
- Arm && Interventions
Group Intervention Description On-X AAP MRI Patients with prior AVR surgery with the CryoLife On-X Ascending Aortic Prosthesis (AAP). SJM Masters or Carbomedics Carbo-seal Transthoracic echocardiography exam 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 On-X AAP Transthoracic echocardiography exam Patients with prior AVR surgery with the CryoLife On-X Ascending Aortic Prosthesis (AAP). SJM Masters or Carbomedics Carbo-seal MRI 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
- 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
Peak Velocity (m/s) 3 months Effective Orifice Area index (EOAi) 3 months
Trial Locations
- Locations (1)
Northwestern University
🇺🇸Chicago, Illinois, United States