18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE): Patients undergo a hybrid 18F-NaF-PET CT scan and TTE at five years after TAVI
Study summary
A multicentre cross-sectional cohort study to assess the difference in bioprosthetic micro-calcification activity, detected with 18F-NaF PET-CT, as early marker of transcatheter valve degeneration, between patients with vs. without subclinical leaflet thrombosis at five years after TAVI; and between patients with intra-annular vs. supra-annular TAVI prostheses.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Successful TAVI with Sapien or CoreValve Evolut prosthesis about 5 years ago
* Able to undergo hybrid 18F-NaF PET-CT imaging and transthoracic echocardiography
* Written informed consent
Exclusion Criteria:
* Temporary or chronic oral anticoagulation use after TAVI
* Known severe renal insufficiency
* Known severe paravalvular regurgitation
* History of valve-in-valve procedure
* History of aortic valve re-intervention (including percutaneous paravalvular leak closure)
Primary outcome measure(s)
Quantified bioprosthetic micro-calcification activity — 5 years after TAVI 18F-NaF uptake originating from any of the bioprosthetic valve leaflets assessed with 18F-NaF Positron Emission Tomography
Subclinical Leaflet Thrombosis — 5 years after TAVI Hypo Attenuated Leaflet Thickening (HALT) assessed with cardiac Computed Tomography
Valve dysfunction — 5 years after TAVI Transvalvular gradients assessed with transthoracic echocardiography
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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