Computational Assessment of Bioprosthetic Aortic Valve Function

Launched by ROYAL BROMPTON & HAREFIELD NHS FOUNDATION TRUST · Mar 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two types of bioprosthetic aortic valves, the Edwards Magna Ease and Intuity Elite, which are designed to replace damaged heart valves. The goal is to understand how these valves work with the heart's structure, particularly how they interact with the left ventricular outflow tract and the aortic root. This information could help improve heart valve treatments for patients with aortic valve disease.

To participate in this trial, you need to be at least 18 years old and have been diagnosed with aortic valve disease, with plans to undergo surgery to receive one of the two valves mentioned. You should also be able to understand the study information and agree to follow the study’s imaging procedures. Unfortunately, if you have certain medical conditions or are under 18, you won’t be eligible. If you join the study, you can expect to undergo imaging tests at specific times to help researchers gather valuable data about how these valves function in the heart. This research could ultimately lead to better treatment options for people with heart valve issues.

Gender

ALL

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.