The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneratio

Recruiting

• Conditions: aortic valve stenosis; narrowing of the aortic valve; 10046973

• Registration Number: NL-OMON53711
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
o Successful TAVI with Sapien or CoreValve Evolut prosthesis about five years
ago
o Able to undergo hybrid 18F-NaF PET-CT scan and transthoracic echocardiography
o Written informed consent

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
o Temporary or chronic oral anticoagulation use after TAVI
o Known severe renal insufficiency
o History of iodine contrast allergy
o Known severe paravalvular regurgitation
o History of valve-in-valve procedure
o History of aortic valve re-intervention (including percutaneous paravalvular
leak closure)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Quantified bioprosthetic micro-calcification activity (18F-NaF uptake)<br /><br>Subclinical leaflet thrombosis (Hypo Attenuating Leaflet Thickening and Reduced<br /><br>Leaflet Motion)<br /><br>Bioprosthetic valve dysfunction</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Demographics, comorbidities, cardiovascular risk factors and scores, clinical<br /><br>status and frailty scales, laboratory values, procedural factors, and baseline<br /><br>and (early) follow-up echocardiography measurements.</p><br>