At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- 18F-sodium fluoride Positron Emission Tomography (18F-NaF PET), Cardiac Computed Tomography (CT), Transthoracic Echocardiography (TTE) (diagnostic test)
- How long the study runs
- Study runs about 35 months (dates as stated)
- About the drug or intervention
- 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
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at people who had a heart valve replacement procedure called TAVI (transcatheter aortic valve implantation) about 5 years ago for a narrowed aortic valve (aortic valve stenosis). It is studying whether a hidden problem called leaflet thrombosis (small clots on the valve that may not cause symptoms) and the type of replacement valve used affect how quickly the new valve wears out over time.
Who can take part
- Had a successful TAVI procedure with a Sapien or CoreValve Evolut replacement valve about 5 years ago
- Able to have two scans: a special scan called 18F-NaF PET-CT and an ultrasound scan of the heart (echocardiogram)
- Able to give written informed consent to take part
Who may not be able to
- Currently taking, or having taken after TAVI, blood-thinning tablets (oral anticoagulation)
- Known severe kidney problems
- Known severe leakage around the edge of the replacement valve
- Having had a second valve placed inside the first one (valve-in-valve procedure)
- Having had the aortic valve repaired or replaced again, including a procedure to close a leak around the valve
What taking part involves
- • Not stated — ask the trial team
Time commitment: Per the data above, taking part involves having hybrid 18F-NaF PET-CT imaging and an ultrasound scan of the heart; number of visits and total study duration not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 180
- Started
- 2023-11-16
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for aortic valve stenosis
- • Clinical study - 180 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with aortic valve stenosis
Where?
- • Edinburgh - University of Edinburgh
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓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 agreement to take part
Who cannot take part
- ✗Temporary or chronic oral anticoagulation use after TAVI
- ✗Known severe kidney insufficiency
- ✗Known severe paravalvular regurgitation
- ✗History of valve-in-valve procedure
- ✗History of aortic valve re-intervention (including percutaneous paravalvular leak closure)
See the full criteria
Where Is This Study? (1 UK site)
University of Edinburgh
Edinburgh, United Kingdom
How to Get in Touch
Dirk-Jan van Ginkel, MD
Sponsor contactCONTACT
Prof. J.M. ten Berg, MD, PhD, MSc
Sponsor contactCONTACT