UnknownNot Applicable

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

Denmark, Netherlands, United Kingdom180 participantsStarted 2023-11-16

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Quantified bioprosthetic micro-calcification activity

Timeframe: 5 years after TAVI

Subclinical Leaflet Thrombosis

Timeframe: 5 years after TAVI

Valve dysfunction

Timeframe: 5 years after TAVI

Trial details

NCT IDNCT05758662

SponsorSt. Antonius Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07

Contact for this trial

Dirk-Jan van Ginkel, MD

+31 (0)88 320 66 48 d.van.ginkel@antoniusziekenhuis.nl

View on ClinicalTrials.gov More Aortic Valve Stenosis trials