The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration (POPular PET TAVI)
The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration
St. Antonius Hospital
180 participants
Nov 16, 2023
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria5
- 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)
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Interventions
Patients undergo a hybrid 18F-NaF-PET CT scan and TTE at five years after TAVI
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT05758662