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Computational Assessment of Bioprosthetic Aortic Valve Function

NCT06306729 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-03-12

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Computed Tomography, Magnetic Resonance Imaging

Computed Tomography, Magnetic Resonance Imaging

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • Imperial College London

    collaborator OTHER

  • Royal Brompton & Harefield NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Saeed Mirsadraee, MD, Ph.D · Royal Brompton & Harefield NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-04-01
Completion
2026-04-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06306729 on ClinicalTrials.gov