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18F-Fluoride Assessment of Aortic Bioprosthesis Durability and Outcome

NCT02304276 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2024-05-21

No results posted yet for this study

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 introduced "key-hole" procedure called transcatheter aortic valve implantation (TAVI). Participants will be recruited at various time points ranging from 1 month to 10 years following valve replacement with either AVR or TAVI. It is thought that progressive calcium (chalk) formation is responsible for the failure of the majority of these valves. All participants will therefore have a PET-CT scan with a special type of "tracer" called 18F-fluoride in order to measure active calcium formation in the valve. They will then have annual clinical follow-up for 5 years and be invited back for a repeat CT scan at 2 years to measure change in calcium burden. This study aims to investigate, firstly, the effects of valve age and type on calcium formation as measured by PET-CT and, secondly, whether this measure of calcium formation can help to predict how long different types of valve will last. If successful, 18F-fluoride PET-CT could become a valuable tool for testing new treatments to improve valve longevity and new valve designs.

Conditions

  • Heart; Complications, Valve, Prosthesis

Interventions

RADIATION

18F-Fluoride PET-CT

Injection of 18F-Fluoride with target activity 125MBq giving an anticipated radiation exposure of 3mSv CT scanning protocol giving an anticipated radiation exposure of 13mSv

RADIATION

CT calcium score of aortic valve

CT associated with an anticipated radiation exposure of 3mSv (Cohorts 2 and 3 only)

Sponsors & Collaborators

  • NHS Lothian

    collaborator OTHER_GOV

  • Cambridge University Hospitals NHS Foundation Trust

    collaborator OTHER

  • Papworth Hospital NHS Foundation Trust

    collaborator OTHER_GOV

  • Bichat Hospital

    collaborator OTHER

  • University of Edinburgh

    lead OTHER

Principal Investigators

  • Marc Dweck, MBChB PhD · University of Edinburgh, Scotland

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-09-30
Completion
2020-10-30

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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 NCT02304276 on ClinicalTrials.gov