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NCT05758662
The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration
Conditions: Aortic Valve Stenosis
Sex: All
Ages: 18 Years – N/A
Enrollment: 180
Sponsor: St. Antonius Hospital
Location: Denmark
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 Criteria
Inclusion Criteria:Successful TAVI with Sapien or CoreValve Evolut prosthesis about 5 years agoAble to undergo hybrid 18F-NaF PET-CT imaging and transthoracic echocardiographyWritten informed consentExclusion Criteria:Temporary or chronic oral anticoagulation use after TAVIKnown severe renal insufficiencyKnown severe paravalvular regurgitationHistory of valve-in-valve procedureHistory of aortic valve re-intervention (including percutaneous paravalvular leak closure)
Source: ClinicalTrials.gov (NCT05758662). StuddyBuddy aggregates publicly available trial information.