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NCT05758662

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·ClinicalTrials.gov·diagnostic testNot yet recruiting
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Study focus
Disease/Condition
Aortic Valve Stenosis
Drug/Device/Intervention
18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE)
Study type
Observational
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
St. Antonius Hospital
Location
Copenhagen,Nieuwegein,Amsterdam,Groningen,Edinburgh, Denmark,Netherlands,United Kingdom
Timeline & enrollment
Phase
N/A
Start date
Apr 01, 2023
End date
Oct 01, 2025
Enrollment
180 participants
Primary outcome

Quantified bioprosthetic micro-calcification activity,Subclinical Leaflet Thrombosis,Valve dysfunction

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.

ICD-10 classifications
Aortic (valve) stenosisAortic (valve) stenosis with insufficiencyCongenital stenosis of aortic valveStenosis of aortaRheumatic aortic stenosis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05758662
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05758662 through Pure Global AI's free database. This phase not specified trial is sponsored by St. Antonius Hospital and is currently Not yet recruiting. The study focuses on Aortic Valve Stenosis. Target enrollment is 180 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.