Status:
COMPLETED
18F-Fluoride Assessment of Aortic Bioprosthesis Durability and Outcome
Lead Sponsor:
University of Edinburgh
Collaborating Sponsors:
NHS Lothian
Cambridge University Hospitals NHS Foundation Trust
Conditions:
Heart; Complications, Valve, Prosthesis
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
This study will evaluate the two main types of replacement tissue heart valve used in current practice, comparing outcomes from surgical aortic valve replacement (AVR) with that of the more recently i...
Detailed Description
Aortic stenosis is the commonest form of valve disease in the western world and the leading indication for valve surgery. Bioprosthetic valves are known to degenerate via a process that is predominant...
Eligibility Criteria
Inclusion
- Cohort 1
- able to provide informed consent
- aged over 40 years
- patients with a bioprosthetic aortic valve who are due to undergo a redo-surgical aortic valve replacement
- Cohort 2
- able to provide informed consent
- aged over 40 years
- patients at 1 month (n=10), 2 years (n=20), 5 years (n=20) and 10 years (n=20) following surgical bioprosthetic aortic valve replacement
- Cohort 3
- able to provide informed consent
- aged over 40 years
- patients at 1 month (n=10), 2 years (n=20) and 5 years (n=20) following transcatheter aortic valve implantation (TAVI) with the Edward's SAPIEN and the COREVALVE.
Exclusion
- Inability to give informed consent
- Pregnancy
- Breastfeeding
- Claustrophobia
- Allergy to iodinated contrast
- Liver failure
- Chronic kidney disease (with estimated glomerular filtration rate \<30 mL/min)
- Metastatic malignancy
- Paget's disease
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT02304276
Start Date
January 1 2015
End Date
October 30 2020
Last Update
May 21 2024
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