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

Recruiting now

Conditions studied: Aortic Valve Stenosis

In brief

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.

Key facts

Study ID

NCT05758662

Run by

St. Antonius Hospital

People needed

180

Starts

2023-11-16

Expected to finish

2026-10-01

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Rigshospitalet — Copenhagen, Denmark (enrolling)
• St. Antonius Hospital — Nieuwegein, Utrecht, Netherlands (enrolling)
• Amsterdam UMC — Amsterdam, Netherlands (enrolling)
• University of Edinburgh — Edinburgh, United Kingdom

Full record on ClinicalTrials.gov

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