Not yet recruitingOBSERVATIONAL

Avr Thrombosis OutcoMe Study

This study is investigating new blood tests to identify people who might be at a higher risk of developing blood clots after having a heart valve replacement. There are two common ways to replace a faulty aortic valve: a traditional surgical operation or a less invasive procedure called TAVI. Sometimes, patients can develop blood clots after these procedures, which can lead to serious problems like strokes or issues with the new valve. Doctors currently give blood-thinning medicines to prevent clots, but these can cause bleeding in some people. The goal of this research is to find a better way to predict who really needs these medicines and who might not, based on special markers in their blood. This could help doctors give the right treatment to the right people, reducing risks for everyone.

At a glance

Status

Not yet recruiting

Sponsor

East and North Hertfordshire NHS Trust

Enrolment target

750

Start

01 Feb 2020

Estimated completion

01 Jan 2028

Aortic Stenosis

What is this study about?

When your aortic valve, one of the main valves in your heart, isn't working properly, it might need to be replaced. This can be done through open-heart surgery (called SAVR) or a less invasive procedure where a new valve is inserted through a catheter (called TAVI). Both treatments are generally very effective, but there's a small chance of developing blood clots afterwards. These clots can sometimes cause serious problems like strokes, or they could affect how well your new valve works over time.

Currently, doctors often give medicines to thin the blood and prevent clots. However, these medicines come with their own risks, mainly an increased chance of bleeding. It's a delicate balance: we want to prevent clots but also avoid unnecessary bleeding. This is why this study is so important. We're looking for better ways to understand who is truly at a higher risk of developing clots after their valve replacement.

Our research focuses on special markers in your blood, which we can measure using simple blood tests. By studying these markers at different times, we hope to identify a 'warning sign' – a unique blood signature – that tells us if someone is more likely to form clots. If we can do this, doctors could then offer targeted blood-thinning medication only to those who need it most, avoiding giving it to people who are at low risk and therefore don't need to take on the extra bleeding risk from the medication. This could make valve replacement procedures even safer for more people.

Key takeaways

This study aims to discover who is most at risk of blood clots after heart valve replacement.
It uses new blood tests to identify special markers for clot risk.
Findings could help doctors give blood-thinning medication only to those who truly need it.
Participation involves blood tests, heart scans, and check-ups over 5 years.
Your involvement helps improve care for future patients with aortic valve disease.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) and have been diagnosed with a problem with your aortic valve for which you are going to have a replacement. You must be able to understand what the study involves and be willing to give your permission to take part. This includes agreeing to follow the study plan, which involves having blood tests and imaging scans at specific times.

There are also some reasons why you might not be able to join. For example, if you have certain serious illnesses that might interfere with the study results, or if you're taking part in another medical research study at the same time. You also can't participate if you have major bleeding problems, active cancer, or certain kidney issues that would make some of the scans unsafe.

This is a general overview, and the study team will discuss all the details with you to make sure it's the right fit and safe for you to participate.

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 surgery or TAVI for an aortic valve problem?
Are you generally in good health (apart from your heart issue)?
Are you able to attend regular appointments and have blood tests?
Are you not currently in another medical research study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have several visits over a period of 5 years. These visits will involve blood tests at different times after your valve replacement. These blood tests will help us look for the special markers mentioned earlier. You will also have regular check-ups with the study team, heart scans (called echocardiograms), and sometimes special CT scans. These scans and check-ups help us monitor your health, how your new valve is working, and check for any issues like bleeding or new clots. The total duration of your involvement in the study, including all follow-up, will be 5 years.

Potential risks and benefits

By taking part, you won't directly receive a new treatment, but your involvement will help us learn more about preventing serious complications after heart valve replacement surgery. This information could benefit many future patients. The main procedures you'll undergo are blood tests and imaging scans, which carry small risks like bruising from blood draws, or very rarely, an allergic reaction to the dye used in some CT scans. We will closely monitor you for any problems. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

East and North Hertfordshire NHS Trust
Verified postcode
Stevenage, United Kingdom

Common questions

What is Aortic Stenosis?

Aortic stenosis is a condition where the main heart valve (the aortic valve) doesn't open fully, making it harder for your heart to pump blood around your body.

What is a 'blood clot' in this study?

In this study, a blood clot refers to a blockage in a blood vessel, which can sometimes form after heart valve replacement and may lead to serious problems like a stroke or affect your new valve.

Will I receive any new medicine in this study?

No, this study is about understanding risk, not testing a new medicine. You will receive standard medical care as decided by your doctors, and your participation will help us find better ways to give those standard clot-preventing medicines.

How often will I need to have blood tests?

You will have blood tests at various times throughout the study, at specific intervals agreed upon by your doctor and the study team. This helps us see how the markers change over time.

What if I decide I don't want to continue with the study?

You can stop participating in the study at any time without having to give a reason, and it will not affect the medical care you receive.

How to find out more

Diana A Gorog, MD,PhD,FRCP

d.gorog@imperial.ac.uk 01707247512 Official trial record

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