Computational Assessment of Bioprosthetic Aortic Valve Function

NCT06306729 | Not Yet Recruiting FDA Device

• 1 other identifier: 316308
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

CFD; Valve Heart Disease

Keywords

Bioprosthesis

Outcome Measures

Primary Outcomes (2)

• blood flow velocities

  Blood flow velocities (cm/s) will be quantified for each bioprosthesis at 3 levels: subvalvular (LVOT and native annulus), transvalvular, the aortic root, and the proximal ascending aorta. Velocities more than 20cm/s will be taken as abnormal.

  12 months

• Time average wall shear stress (TAWSS)

  TAWSS will be quantified for each bioprosthesis at 3 levels: subvalvular (LVOT, the aortic root, and the proximal ascending aorta. TAWSS under 0.5Pa is taken as low, 0.51-2.0 as moderately increased, \>2.0 Pa as severely increased TAWSS.

  12 months

Secondary Outcomes (3)

• Patient's satisfaction

  12 months

• Evidence of major adverse cardiac and cerebrovascular events (MACCE)

  12 months

• Mortality

  12 months

Study Arms (2)

Standard Implantation

Diagnostic Test: Computed Tomography, Magnetic Resonance Imaging

Rapid Deployment

Diagnostic Test: Computed Tomography, Magnetic Resonance Imaging

Interventions

Computed Tomography, Magnetic Resonance Imaging DIAGNOSTIC_TEST

Computed Tomography, Magnetic Resonance Imaging

Rapid Deployment; Standard Implantation

Eligibility Criteria

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

You may qualify if:

• Male and female patients aged 18 years or over.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• Edwards Lifesciences: collaborator
• Imperial College London: collaborator

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Tomography, X-Ray Computed; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Saeed Mirsadraee, MD, Ph.D

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saeed Mirsadraee, MD, Ph.D

CONTACT

02073528121; s.mirsadraee@rbht.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: March 12, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share