RecruitingOBSERVATIONAL

The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration (POPular PET TAVI)

This study wants to understand why replacement heart valves, put in during a procedure called TAVI for a condition called Aortic Valve Stenosis, might start to wear out. We're particularly interested in tiny blood clots on these valves, which people often don't even know they have. Doctors call these 'subclinical leaflet thrombosis'. We also want to compare two main types of replacement valves — 'intra-annular' and 'supra-annular' — to see if one type shows more early signs of wear and tear after five years. To do this, we're using special scans to look for very early signs of calcium building up in the valves, which can be an early warning of future problems.

At a glance

Status

Recruiting

Sponsor

St. Antonius Hospital

Enrolment target

180

Start

16 Nov 2023

Estimated completion

01 Oct 2026

Aortic Valve Stenosis

What is this study about?

When people have a procedure called TAVI for a condition called Aortic Valve Stenosis, they get a new heart valve. Sometimes, tiny blood clots, too small to cause symptoms, can form on these new valves. Eventually, these clots might harden with calcium, making the valve stiff and worn out over time. We also know that some types of TAVI valves might be more likely to develop these tiny clots because of how they fit in the heart and how blood flows around them.

This study is looking at patients who had a TAVI procedure about five years ago. We want to see if these tiny blood clots affect how quickly the new valve starts to show early signs of damage. We're also comparing two main types of replacement valves — those called 'intra-annular' and those called 'supra-annular' — to see if one type shows more early signs of wear and tear. No one has really looked at this difference before.

To find these very early signs of damage, we use a special kind of scan that can spot tiny amounts of calcium activity in the valve. This calcium build-up is a very early warning sign that the valve might not last as long as expected. By understanding these issues better, we hope to improve the long-term success of TAVI procedures for future patients.

Key takeaways

Looks at how different TAVI heart valves wear out over 5 years.
Investigates the role of tiny, unnoticed blood clots on valve lifespan.
Compares two main types of TAVI valves: intra-annular and supra-annular.
Uses special scans to find very early signs of valve damage (calcification).
Aims to improve long-term outcomes for TAVI patients.
Participation involves specific heart scans and tests.

Who may be eligible?

This study is looking for adults who had a specific type of heart valve replacement surgery (TAVI) about five years ago. You would need to have received either a Sapien or a CoreValve Evolut type of valve, and the procedure must have been successful.

To take part, you need to be well enough to safely have special scans and tests, including a particular type of PET scan, a CT scan, and a heart ultrasound. Also, it's very important that you can understand what the study involves and agree to participate by giving your written consent.

Some things would mean you couldn't join. For example, if you're currently taking blood-thinning medication (anticoagulants) or if you have severe kidney problems. You also wouldn't be able to join if you have a history of certain other heart valve procedures or problems, such as severe leakage around your valve or if your valve has been re-intervened on.

Quick self-check

Did I have a TAVI procedure about 5 years ago?
Was my TAVI valve either a Sapien or a CoreValve Evolut?
Am I generally well enough for scans like PET and CT?
Am I NOT currently taking blood-thinning medicines (anticoagulants)?
Do I NOT have severe kidney problems or other specific heart issues?
Can I understand and give written consent to join the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will need to come in for specific tests. This will involve having a special type of PET scan combined with a CT scan. You will also have an ultrasound of your heart, called an echocardiogram. These are standard tests that help doctors look at your heart and valve. You won't be given any new medication as part of this study. This is a one-time assessment, and there isn't a long-term follow-up period; all the necessary information will be gathered during these visits. The total duration of your participation will be limited to the time it takes to complete these scans and assessments.

Potential risks and benefits

The potential benefits of participating might include gaining a deeper understanding of your own heart valve's health, and helping doctors learn more about how TAVI valves perform over many years, which could improve care for future patients. The main risks are associated with the scans, such as exposure to a small amount of radiation from the PET and CT scans, similar to what you'd get from other medical imaging. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Rigshospitalet
Copenhagen, Denmark· Recruiting
St. Antonius Hospital
Nieuwegein, Netherlands· Recruiting
Amsterdam UMC
Amsterdam, Netherlands· Recruiting
University of Edinburgh
Edinburgh, United Kingdom· Not yet recruiting

Common questions

What is Aortic Valve Stenosis?

It's a condition where your heart's aortic valve, which controls blood flow out of your heart, becomes narrowed and stiff, making it harder for your heart to pump blood.

What is TAVI?

TAVI stands for Transcatheter Aortic Valve Implantation. It's a procedure to replace a narrowed aortic valve without open-heart surgery, often by guiding a new valve through a blood vessel.

What are 'subclinical leaflet clots'?

These are very tiny blood clots that can form on your new heart valve. They're 'subclinical' because they're too small to cause any symptoms you would notice.

What is an 18F-NaF PET-CT scan?

It's a special type of imaging scan that can see very early signs of calcium building up in your heart valve, which might indicate early wear and tear.

Will I get medication in this study?

No, this study only involves having scans and tests; you will not be given any new medication as part of your participation.

How to find out more

Dirk-Jan van Ginkel, MD

d.van.ginkel@antoniusziekenhuis.nl +31 (0)88 320 66 48 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.