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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration
- ClinicalTrials.gov ID
- NCT05758662
- Acronym / sponsor ID
- NL82791.100.23
- Conditions
- Aortic Valve Stenosis
- Keywords
- TAVI, TAVR, Subclinical Leaflet Thrombosis, Bioprosthetic Valve Deterioration, Intra-annular, Supra-annular
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Collaborators
- St. Antonius Research Fund, Medtronic
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-annular | – | Diagnostic Test: 18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE)Patients with an intra-annular Sapien TAVI prosthesis |
| Supra-annular | – | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | Intra-annular, Supra-annular |
Primary outcome
Quantified bioprosthetic micro-calcification activity
Time frame: 5 years after TAVI
18F-NaF uptake originating from any of the bioprosthetic valve leaflets assessed with 18F-NaF Positron Emission Tomography
Subclinical Leaflet Thrombosis
Time frame: 5 years after TAVI
Hypo Attenuated Leaflet Thickening (HALT) assessed with cardiac Computed Tomography
Valve dysfunction
Time frame: 5 years after TAVI
Transvalvular gradients assessed with transthoracic echocardiography
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided. Decided upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. J.M. ten Berg, MD, PhD, MSc contact
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by St. Antonius Hospital at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, Denmark, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dirk-Jan van Ginkel, MD (+31 (0)88 320 66 48, d.van.ginkel@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantified bioprosthetic micro-calcification activity (time frame: 5 years after TAVI). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.