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

Sponsors and collaborators

St. Antonius Hospital

Lead sponsor

St. Antonius Research Fund

Collaborator

Medtronic

Collaborator