Clinical trial NCT03347851: Post-surgical Aortic Hemodynamics After Aortic Valve Replacement
Official title: Investigation of Post-surgical Aortic Hemodynamics After Aortic Valve Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Valve Heart Disease
Keywords: mechanical heart valve
On-X
Lead sponsor: CryoLife
Sponsor class: UNKNOWN
Collaborators: name: Northwestern University
First posted: 2017-11-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Downstream flow patterns (helicity and vorticity)
timeFrame: 3 months
measure: Hinge washout
timeFrame: 3 months
measure: Energy loss
timeFrame: 3 months
measure: Wall shear stress (WSS)
timeFrame: 3 months
Secondary outcomes:
measure: Ejection Fraction (%)
timeFrame: 3 months
measure: Primary EDV (ml)
timeFrame: 3 months
measure: Normalized EDV (ml/m^2)
timeFrame: 3 months
measure: Primary ESV (mL)
timeFrame: 3 months
measure: Normalized ESV (mL/m^2)
timeFrame: 3 months
measure: Peak Velocity (m/s)
timeFrame: 3 months
measure: Mean velocity (m/s)
timeFrame: 3 months
measure: Peak transvalvular pressure gradient (mmHg)
timeFrame: 3 months
measure: Mean transvalvular pressure gradient (mmHg)
timeFrame: 3 months
measure: Effective Orifice Area (EOA)
timeFrame: 3 months
measure: Effective Orifice Area index (EOAi)
timeFrame: 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References: