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NCT05758662 Clinical Trial

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

Aortic Valve Stenosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05758662
Other study ID # NL82791.100.23
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 16, 2023
Est. completion date November 2025

Study information
Verified date April 2024
Source St. Antonius Hospital
Contact Dirk-Jan van Ginkel, MD
Phone +31 (0)88 320 66 48
Email d.van.ginkel@antoniusziekenhuis.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

Subclinical leaflet thrombosis (SCLT) occurs frequently after TAVI and has been associated with an increased risk of valve dysfunction. A persistent form of SCLT may lead to thrombus calcification and valve degeneration and increase the long-term risk of symptomatic bioprosthetic valve deterioration. Intra-annular in comparison to supra-annular TAVI valves have been associated with a higher risk of SCLT and valve thrombosis. Intra-annular valves may create larger neo-sinuses and flow stagnation zones, which favour local thrombogenicity. Whether different prosthesis types lead to a higher degree of transcatheter valve calcification and degeneration is currently unexplored. Recently, 18F-sodium fluoride (18F-NaF) positron emission tomography (PET) has emerged as a non-invasive modality capable of imaging bioprosthetic micro-calcification activity, which is an early and powerful predictor of valvular dysfunction and eventually valve failure. In the present study, we investigate for the first time, the differences in quantified bioprosthetic micro-calcification activity with 18F-NaF PET as early marker of transcatheter valve degeneration between patients with and without SCLT and between patients with intra-annular vs. supra-annular prostheses at five years after TAVI.

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date November 2025
Est. primary completion date July 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

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
Country Name City State
Denmark Rigshospitalet Copenhagen
Netherlands Amsterdam UMC Amsterdam
Netherlands St. Antonius Hospital Nieuwegein Utrecht
United Kingdom University of Edinburgh Edinburgh

Sponsors (3)
Lead Sponsor Collaborator
St. Antonius Hospital Medtronic, St. Antonius Research Fund

Countries where clinical trial is conducted

Denmark,  Netherlands,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quantified bioprosthetic micro-calcification activity 18F-NaF uptake originating from any of the bioprosthetic valve leaflets assessed with 18F-NaF Positron Emission Tomography 5 years after TAVI
Primary Subclinical Leaflet Thrombosis Hypo Attenuated Leaflet Thickening (HALT) assessed with cardiac Computed Tomography 5 years after TAVI
Primary Valve dysfunction Transvalvular gradients assessed with transthoracic echocardiography 5 years after TAVI
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