- The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration (POPular PET TAVI) — Recruiting • Cardiology / Cardiovascular • NCT05758662.
- What is being tested: The study investigates whether subclinical leaflet thrombosis detected on imaging predicts early bioprosthetic valve degeneration in TAVI patients at five years post-procedure, using 18F-NaF PET-CT to measure micro-calcification activity as a marker of valve deterioration.
- Patient eligibility overview: The trial includes patients who received transcatheter aortic valve implants (TAVI) five years prior, stratified by presence or absence of subclinical leaflet thrombosis and by prosthesis type, allowing comparison of valve degeneration patterns across these groups.
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- Connecting this trial to nearby guidelines, Drug Science and education.
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.
- : * 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.