Aortic Valve StenosisNCT05758662
The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration (POPular PET TAVI)
An observational study of Aortic Valve Stenosis, run by St. Antonius Hospital at 4 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- 18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE)
- How many people
- 180 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 16 Nov 2023to 1 Oct 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Prof. J.M. ten Berg, MD, PhD, MSc contact
4 sites in 3 countries
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Dr. R. Delewi, MD, PhD
- Recruiting
St. Antonius Hospital
Nieuwegein, Utrecht, 3435 CM
Dirk-Jan van Ginkel, MD, +31 (0)88 320 66 48, d.van.ginkel@antoniusziekenhuis.nl
Prof. J.M. ten Berg, MD, PhD, MSc
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen
Prof. O. De Backer, MD, PhD
United Kingdom1 site, 1 recruiting
- Not yet recruiting
University of Edinburgh
Edinburgh
Prof. M. Dweck, MD, PhD
About this study
Official title: The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration
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.
Read the 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- 18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE)
- Keywords
- TAVI, TAVR, Subclinical Leaflet Thrombosis, Bioprosthetic Valve Deterioration, Intra-annular, Supra-annular
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE)Diagnostic test
Patients undergo a hybrid 18F-NaF-PET CT scan and TTE at five years after TAVI
| Study group | Role | What they receive |
|---|---|---|
| Intra-annular | Patients with an intra-annular Sapien TAVI prosthesis Receives: Diagnostic Test: 18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE) | |
| Supra-annular | Patients with a supra-annular CoreValve Evolut TAVI prosthesis Receives: Diagnostic Test: 18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantified bioprosthetic micro-calcification activity
18F-NaF uptake originating from any of the bioprosthetic valve leaflets assessed with 18F-NaF Positron Emission Tomography
Measured: 5 years after TAVI
Subclinical Leaflet Thrombosis
Hypo Attenuated Leaflet Thickening (HALT) assessed with cardiac Computed Tomography
Measured: 5 years after TAVI
Valve dysfunction
Transvalvular gradients assessed with transthoracic echocardiography
Measured: 5 years after TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start16 Nov 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Antonius Research Fund, Medtronic
- Responsible party
- Principal investigator, Jurriën M. ten Berg, MD, PhD, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758662
- Sponsor's protocol ID
- NL82791.100.23
- Status last verified
- May 2026
- First submitted
- 15 Feb 2023
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Decided upon request