The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve De… (NCT05758662) | Clinical Trial Compass
RecruitingNot Applicable
The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration (POPular PET TAVI)
Denmark, Netherlands, United Kingdom180 participantsStarted 2023-11-16
Plain-language 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. without subclinical leaflet thrombosis at five years after TAVI; and between patients with intra-annular vs. supra-annular TAVI prostheses.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is using PET imaging to look at tiny calcium deposits and blood clots forming on TAVI valve leaflets before symptoms appear — would having this kind of imaging help my care team catch valve problems earlier than standard follow-up would?
2The study is looking at whether subclinical leaflet thrombosis — small clots on the valve that don't cause obvious symptoms yet — could be quietly damaging my replacement valve over time, so could my doctor explain whether this is a known risk with the type of prosthesis I'm being offered?
3Since this is a non-interventional observational study rather than a treatment trial, does taking part mean any changes to my actual treatment plan, or would I mainly be undergoing extra imaging and monitoring on top of my usual care?
4The trial is comparing different types of TAVI prostheses to see how they hold up over time — does my doctor know which prosthesis type I'd receive, and is there evidence that one type performs better for my specific situation?
5Given that this trial is still recruiting and focused on understanding how TAVI valves degrade rather than testing a new therapy, would my doctor recommend I consider standard surgical options or a currently proven medical management approach while this research is still ongoing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.