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The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration (POPular PET TAVI)

Recruitingn/aAges 18 Years - anyAllSt. Antonius Hospital
NCT05758662 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • 18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE)
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Where

4 sites
Rigshospitalet
Copenhagen, Denmark
St. Antonius Hospital
Nieuwegein, Netherlands
Amsterdam UMC
Amsterdam, Netherlands
University of Edinburgh
Edinburgh, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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