Clinical trial NCT06306729: Computational Assessment of Bioprosthetic Aortic Valve Function
Official title: Comparing the In-vivo Haemodynamic and Biomechanical Performance of Rapid-deployment Edwards Intuity Elite System and Edwards Magna Ease Valve
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: CFD
Valve Heart Disease
Keywords: Bioprosthesis
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
name: Imperial College London
First posted: 2024-03-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 informed and consented patients who undergo the Intuity Elite (n=10) and Magna EASE (n=10) valves will be prospectively enrolled. The patients will be evaluated at 3- and 12-months post valve replacement.

Brief summary: Bioprosthetic valves are usually made of biological tissue that are mounted to a frame and are designed to function similarly to a healthy natural valve. Edwards Magna Ease and Intuity Elite bioprosthetic valves have similar leaflets and mounting designs. However, the valves are implanted in the patient in different ways (one is stitched to the wall of the left ventricular outflow tract, and the other is held in place by the radial force of the valve skirt). The study aims to understand in more detail how the different valves interact with the left ventricular outflow tract and aortic root.

Detailed description: The implantation of a bioprosthetic valve is the established surgical technique when replacing the aortic valve to treat various aortic valve diseases. Many different bioprosthetic valves are available. The design and implantation technique in each system would result in different interaction with the left ventricular outflow tract (LVOT) and the aortic root, leading to different flow profiles that may induce platelet aggregation and affect the long-term performance of the bioprosthesis and its durability. Additionally, complications such as valve thrombosis may occur. However, it is not currently clear which bioprostheses/patients are more prone to thrombosis or degradation of the valve. This study aims to develop fluid-structure interaction (FSI) models, which can model blood flow and wall/valve mechanics, using realistic patient-specific geometries and flow conditions which correlate with the true performance of the valve in the imaged patients, and to assess and compare such performances to understand the benefits and challenges with various bioprosthetic valves.

FSI models combine computational fluid mechanics (CFD) with structural wall mechanics modelling. This is an alternative approach that allows detailed assessment of flow patterns and estimation of wall shear stress and pressure within blood vessels, and therefore has been applied increasingly to gain better insights into the hemodynamics in cardiovascular diseases

Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 18 years or over.
* Patients diagnosed with aortic valve disease, and scheduled to undergo Edwards Magna Ease or Intuity Elite and free of exclusion criteria below.
* The patient is willing and able to understand the Patient Information Sheet and provide written informed consent.
* The patient must agree to comply with the study imaging protocol as required at prespecified times.

Exclusion Criteria:

* Inability to provide valid informed consent.
* Male and female patients aged \< 18 years of age.
* Contraindications for CT angiography: renal failure (Cr\>250 μmol/L or eGFR\<30 mL/min) due to the additional risk of contrast medium nephrotoxicity or allergy to iodine.
* Women of childbearing age who have not had a hysterectomy and/or who may be breastfeeding.
* History of cardiac pacing device insertion, or any other MRI incompatible device implants.

Primary outcomes:
measure: blood flow velocities
timeFrame: 12 months
measure: Time average wall shear stress (TAWSS)
timeFrame: 12 months
Secondary outcomes:
measure: Patient's satisfaction
timeFrame: 12 months
measure: Evidence of major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Saeed Mirsadraee, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: