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

RECRUITINGSponsored by St. Antonius Hospital
Actively Recruiting
SponsorSt. Antonius Hospital
Started2023-11-16
Est. completion2025-07
Eligibility
Age18 Years+
View on ClinicalTrials.gov →

NCT05758662

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

Age: 18 Years+
Inclusion Criteria:

* 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 Criteria:

* 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)

Conditions2

Aortic Valve StenosisHeart Disease

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