Pure Global

The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration (POPular PET TAVI) - Trial NCT05758662

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.

Free Database
Powered by Pure Global AI
840K+ Trials
NCT05758662
Not yet recruiting
diagnostic test
Trial Details
ClinicalTrials.gov โ€ข NCT05758662
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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

Study Focus

Aortic Valve Stenosis

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

Observational

diagnostic test

Sponsor & Location

St. Antonius Hospital

Copenhagen,Nieuwegein,Amsterdam,Groningen,Edinburgh, Denmark,Netherlands,United Kingdom

Timeline & Enrollment

N/A

Apr 01, 2023

Oct 01, 2025

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) stenosis
Aortic (valve) stenosis with insufficiency
Congenital stenosis of aortic valve
Stenosis of aorta
Rheumatic aortic stenosis

Data Source

ClinicalTrials.gov

NCT05758662

Non-Device Trial