ConditionAortic Valve Stenosis
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 groupsSponsors and collaborators
Source ClinicalTrials.gov