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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSt. Antonius Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Temporary or chronic oral anticoagulation use after TAVI

Known severe renal insufficiency

Known severe paravalvular regurgitation

History of valve-in-valve procedure

Trial design

Treatments tested in this trial

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

Treatment groups

180 Participants
are divided into 2 treatment groups

Locations

4
Denmark
Rigshospitalet Copenhagen Denmark
Netherlands
St. Antonius Hospital3435 CM, NieuwegeinUtrecht, Netherlands
Amsterdam UMC Amsterdam Netherlands
United Kingdom
University of Edinburgh Edinburgh United Kingdom

Sponsors and collaborators

St. Antonius Hospital

Lead sponsor

St. Antonius Research Fund

Collaborator

Medtronic

Collaborator