Not yet recruitingOBSERVATIONAL

Outcome Prediction in Patients With Aortic Stenosis After TAVI

This study is about learning more about how people recover after a heart procedure called TAVI (Transcatheter Aortic Valve Implantation). TAVI is used to replace a narrowed heart valve (aortic stenosis), which can cause breathlessness and chest pain. While TAVI has greatly improved, some patients don't feel much better afterwards. We aim to find better ways to predict who will benefit most from TAVI. This research will focus on how the right side of the heart works and recovers after the procedure, as this hasn't been studied in depth before. Understanding this could help doctors choose the best treatment for each patient.

At a glance

Status

Not yet recruiting

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrolment target

Start

01 Oct 2023

Estimated completion

01 Feb 2027

Aortic Stenosis, Severe

What is this study about?

When you get older, a problem called aortic stenosis can happen. This is when one of the main valves in your heart, called the aortic valve, becomes narrow. This narrowing makes your heart work much harder to pump blood around your body, and it can leave you feeling breathless, having chest pain, or even fainting. If it's not treated, it can be very serious.

For a long time, the only way to fix this was with major open-heart surgery, which was too risky for many people. Thankfully, in the last ten years, a newer procedure called TAVI has become available. TAVI involves putting a new valve into your heart through a small tube, usually placed in your leg. This means you don't need major surgery, making it a safer option for many.

While TAVI has been very successful for many, some people don't get as much benefit as hoped. Nearly a third of patients don't feel an improvement in their quality of life, or they sadly pass away within the first year. We want to understand why this happens and find better ways to predict who will do well after TAVI. This study will specifically look at how the right side of your heart recovers after the procedure, which hasn't been a main focus in the past, but we think could be important for predicting how well you'll recover overall.

Key takeaways

This study is about understanding recovery after TAVI for a narrowed heart valve.
It aims to find better ways to predict who benefits most from the procedure.
The focus is on how the right side of the heart recovers.
You won't receive new treatments, just have your progress observed.
Participation helps improve care for future patients with aortic stenosis.

Who may be eligible?

To be considered for this study, you would need to have severe aortic stenosis, which means your aortic valve is significantly narrowed and causing symptoms. Your doctor would use specific measurements to confirm this.

There are several reasons why someone might not be able to join this study. For example, if you have other heart problems (like a very weak heart or another serious valve issue not related to aortic stenosis), or if you have serious lung disease, you might not be eligible. Also, if you can't walk easily due to problems not related to your heart, or if you're already taking part in another study that might interfere with this one, you wouldn't be able to participate. This study is for people aged 18 and over, and it's open to all genders.

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.

Do you have severe aortic stenosis?
Are you 18 years old or older?
Are your walking difficulties mainly due to your heart condition?
Do you not have other serious heart conditions (like a very weak heart or other severe valve problems)?
Are you not currently part of another clinical study?

Answer every question to see your result.

What does participation involve?

This is an 'observational' study, which means we will be carefully watching and recording what happens to patients who have the TAVI procedure. You won't be given any new treatments or medicines that are different from what your doctor would normally recommend. We will simply be collecting information about your heart's function and how you feel before and after your TAVI procedure. This will likely involve standard assessments like scans or tests that are routinely done when you have TAVI. We will be looking at how well you recover and how your symptoms improve. The total duration of your participation would depend on the study's follow-up schedule, but it would involve a few extra assessments or questionnaires at specific times after your TAVI.

Potential risks and benefits

The main benefit of taking part in this study is helping us learn more about TAVI and improve the care for future patients with aortic stenosis. This study itself doesn't involve any new medical interventions, so for you, there are no extra medical risks beyond those of the TAVI procedure itself, which your doctor will explain fully. We will be using information from your routine medical care. You have the right to withdraw from the study at any time 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.

Guy's & St Thomas' NHS Foundation Trust, St Thomas' Hospital
Verified postcode
London, United Kingdom

Common questions

What is 'aortic stenosis'?

It's when a main valve in your heart (the aortic valve) gets narrow, making it harder for your heart to pump blood.

What is 'TAVI'?

TAVI (Transcatheter Aortic Valve Implantation) is a procedure to replace a narrowed heart valve using a small tube, often placed in the leg, instead of open-heart surgery.

Will I get a new treatment in this study?

No, this study just observes patients getting the standard TAVI procedure; you won't receive any new treatments.

Who can join this study?

Adults (18+) with severe aortic stenosis who meet specific health criteria can be considered.

Why is this study important?

It aims to help doctors better predict who will benefit most from TAVI, improving patient selection and outcomes for this important heart procedure.

How to find out more

Vitaliy Androshchuk

vitaliy.androshchuk@gstt.nhs.uk 02071881083 Official trial record

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