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RECRUITING
NCT05758662

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

Sponsor: St. Antonius Hospital

View on ClinicalTrials.gov

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.

Official title: The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

180

Start Date

2023-11-16

Completion Date

2025-11

Last Updated

2024-04-10

Healthy Volunteers

Not specified

Interventions

DIAGNOSTIC_TEST

18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE)

Patients undergo a hybrid 18F-NaF-PET CT scan and TTE at five years after TAVI

Locations (4)

Rigshospitalet

Copenhagen, Denmark

St. Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Amsterdam UMC

Amsterdam, Netherlands

University of Edinburgh

Edinburgh, United Kingdom