The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration (POPular PET TAVI)
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE).
- Who it may be relevant to
- Registry conditions: Aortic Valve Stenosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark, Netherlands, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration
Overview
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.
Detailed 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.
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
Primary outcome measures
- Quantified bioprosthetic micro-calcification activity [Time frame: 5 years after TAVI]
- Subclinical Leaflet Thrombosis [Time frame: 5 years after TAVI]
- Valve dysfunction [Time frame: 5 years after TAVI]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Netherlands · 2 centers
- St. Antonius Hospital — Nieuwegein
- Amsterdam UMC — Amsterdam
Denmark · 1 center
- Rigshospitalet — Copenhagen
United Kingdom · 1 center
- University of Edinburgh — Edinburgh
Identifiers
NCT: NCT05758662 · NL82791.100.23