An observational study in Aortic Valve Stenosis, sponsored by St. Antonius Hospital. Recruiting at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by St. Antonius Hospital · Observational
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.
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.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 180 is close to the median of 200 across 435 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →St. Antonius Hospital is the lead sponsor of 97 studies on the registry; 28 are open to participants now.
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Patients who underwent TAVI about five years ago will be consecutively screened for eligibility from the ongoing, prospective, TAVI registries of the participating study sites and will be asked to undergo hybrid PET-CT imaging and transthoracic echocardiography.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with an intra-annular Sapien TAVI prosthesis
Diagnostic Test: 18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE)
Patients with a supra-annular CoreValve Evolut TAVI prosthesis
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
Quantified bioprosthetic micro-calcification activity
18F-NaF uptake originating from any of the bioprosthetic valve leaflets assessed with 18F-NaF Positron Emission Tomography
Time frame: 5 years after TAVI
Subclinical Leaflet Thrombosis
Hypo Attenuated Leaflet Thickening (HALT) assessed with cardiac Computed Tomography
Time frame: 5 years after TAVI
Valve dysfunction
Transvalvular gradients assessed with transthoracic echocardiography
Time frame: 5 years after TAVI
Plan to share: Undecided — Decided upon request
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