A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI)
This study aims to understand if scans taken before a TAVI (Transcatheter Aortic Valve Implantation) heart valve procedure can help predict how well the new valve will perform over time. TAVI is a way to replace a narrowed heart valve (aortic stenosis) without open-heart surgery. To do this, we'll compare the usual CT scan data from before the procedure with a new CT scan taken six months afterwards. Currently, this second CT scan isn't usually done. We hope the information from these scans will help train a computer program to better predict how well TAVI valves work in the future for people with severe aortic stenosis. Taking part means having an additional CT scan six months after your TAVI.
At a glance
What is this study about?
Imagine your heart has a valve that isn't opening properly, making your heart work harder. This condition is called severe aortic stenosis. A treatment for this is called TAVI, where doctors put in a new valve using a thin tube, without major surgery. Before your TAVI, you'll have some scans like a CT scan and a heart echo scan (TTE) to plan the procedure.
This study is trying to find out if the information from these pre-procedure scans can give us clues about how well your new TAVI valve will work in the future. To do this, we'll also ask people taking part to have an extra CT scan about six months after their TAVI procedure. This second CT scan is not usually part of routine care. By comparing the scans from before and after, along with other routine measurements, we hope to see if any changes occur in the valve's performance.
The information from all these scans will be fed into a special computer program. This program will then 'learn' from the data to become better at predicting how TAVI valves perform over time. The main goal is to gather these important scan images before and after the TAVI procedure to help us better understand and predict how well these life-changing valves will perform for patients like you.
Key takeaways
- This study uses scans to predict TAVI valve performance.
- You'll have an extra CT scan 6 months after your TAVI.
- Data will train a computer to improve future predictions.
- No direct benefit, but helps future patients.
- Your TAVI procedure is unchanged by participation.
- You can stop participating at any time.
Who may be eligible?
This study is looking for men and women aged 18 or older who are having a TAVI procedure for severe aortic stenosis. This means your aortic heart valve is very narrowed, making it hard for blood to flow out of your heart, and you're experiencing symptoms. Your existing scans (CT and heart echo) need to be clear and of good quality for thorough analysis.
You would need to be in a regular heart rhythm (not an irregular one) when your scans are done. Importantly, you must be undergoing a successful TAVI procedure using a specific type of valve (Edwards Sapien 3 Ultra) where the valve is placed correctly and there are no major immediate problems.
Unfortunately, you wouldn't be able to join if you have other serious heart valve problems, if you've already had a TAVI or open-heart surgery for your aortic valve, or if your life expectancy is considered to be less than six months. Also, certain kidney problems, a recent heart attack, or if you're taking specific blood-thinning medications or have a very weak heart (low LVEF) would prevent you from taking part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you having a TAVI procedure for severe aortic valve narrowing?
- Will your TAVI use an Edwards Sapien 3 Ultra valve?
- Do you not have other severe heart valve problems?
- Have you not had a previous TAVI or aortic valve surgery?
- Do you have a life expectancy greater than 6 months?
What does participation involve?
If you decide to take part in this study, you will have your usual CT scan and heart echo scan before your TAVI procedure. The only additional thing we would ask of you is to have an extra CT scan about six months after your TAVI procedure. This will happen during one of your routine follow-up appointments. There are no extra visits specifically for the study beyond attending your scheduled follow-up, during which this extra scan would take place. You will not be given any study medication. The total duration of your active participation, including this extra scan, would be up to approximately six months after your TAVI procedure.
Potential risks and benefits
Locations (1)
- St Bartholomew's HospitalVerified postcodeLondon, United Kingdom· Recruiting
Common questions
What is TAVI?
TAVI stands for Transcatheter Aortic Valve Implantation. It's a procedure to replace a narrowed aortic heart valve using a thin tube inserted through a blood vessel, avoiding open-heart surgery.
Why do I need an extra scan?
The extra CT scan at six months will help us compare your heart before and after the TAVI. This helps us learn if the initial scans can predict how well the new valve will work long-term.
Will taking part affect my TAVI procedure?
No, taking part will not change how your TAVI procedure is planned or performed. It's about gathering extra information after your procedure.
What happens to my scan data?
Your scan data will be used in a computer program to help it learn and predict how TAVI valves perform in the future, improving care for future patients.
Can I change my mind about participating?
Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your medical care or relationship with your doctors.
How to find out more
R&D Governance Administrator
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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