Predicting outcomes following intervention for tricuspid regurgitation
This study focuses on a heart condition called tricuspid regurgitation, which means the heart's tricuspid valve isn't closing properly, causing blood to leak backward. This can be serious, especially for patients who can't have traditional surgery. Recently, new, less invasive 'keyhole' treatments have become available for this condition. These treatments help fix the leaky valve without open-heart surgery. Researchers want to understand how patients respond to these new treatments and find out which individuals are most likely to benefit. The study will involve extra health checks and quality of life assessments for participants to track their progress and help doctors predict how well therapies will work for others in the future.
At a glance
What is this study about?
This study is about a heart problem called tricuspid regurgitation. This happens when one of your heart valves, the tricuspid valve, doesn't close tightly. This causes blood to flow backward in your heart, which can make you feel tired or breathless and can be quite serious if it's severe. For a long time, there weren't many treatment options for patients who were too unwell for traditional open-heart surgery.
Good news! Newer, less invasive treatments have recently been developed. These treatments use 'keyhole' techniques, meaning doctors can insert small tubes to fix or replace the leaky valve without needing major surgery. These new methods are a game-changer for many patients. This study aims to closely watch patients who receive these treatments. The main goal is to learn how well these treatments work for different people and to figure out what factors might help predict who will get the most benefit.
By gathering this information, doctors hope to improve our understanding of these new treatments. This will help them decide which patients are most likely to do well with these procedures in the future, ultimately improving care and quality of life for many individuals living with a leaky tricuspid valve.
Key takeaways
- The study explores new 'keyhole' treatments for a leaky heart valve (tricuspid regurgitation).
- It aims to understand how well these treatments work and predict who will benefit most.
- Participants will receive the new treatment and have extra health checks.
- Potential benefits include improved heart function and quality of life.
- The study has some risks, like any medical procedure, which will be discussed.
- It is run by King's College London and funded by Edwards Lifesciences and the British Heart Foundation.
Who may be eligible?
This study is looking for adults aged 18 to 110 years old who have severe tricuspid regurgitation, which means their tricuspid heart valve is very leaky. You would need to have been assessed by a team of heart specialists who have agreed that one of these new, less invasive 'keyhole' treatments is a suitable option for you.
There are some reasons why you might not be able to join. For example, if the doctors find that the shape of your heart or its blood flow isn't suitable for these specific keyhole procedures, or if you have another serious heart valve problem that needs treatment. You also can't take part if you are pregnant, under 18, or already involved in another study that might affect this one.
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 tricuspid regurgitation (a very leaky heart valve)?
- Have your heart specialists said a 'keyhole' tricuspid valve treatment is right for you?
- Are you aged 18 years or older?
- Are you not pregnant?
- Do you not have other heart conditions that need surgery or intervention?
- Are you not already in another study that might affect this one?
What does participation involve?
If you decide to take part in this study, you will receive one of the new 'keyhole' treatments for your leaky tricuspid valve, as planned by your medical team. On top of your usual care, you'll have some extra health checks both before the treatment and during follow-up visits. These extra checks might include tests to see how well your heart is working and questionnaires to understand your quality of life and physical abilities. Some of these tests might involve measuring pressures and blood flow inside your heart. The study is expected to run from December 2024 to March 2028, and your participation would involve assessments over this period to see how you are doing after treatment.
Potential risks and benefits
Locations (3)
- Guy's and St Thomas' HospitalsCity onlyLondon, England
- Royal Brompton HospitalApproximateLondon, England
- John Radcliffe HospitalApproximateOxford, England
Common questions
What is tricuspid regurgitation?
It's a heart condition where one of your heart valves, called the tricuspid valve, doesn't close properly, causing blood to leak backward in your heart.
What are 'keyhole' treatments?
These are less invasive procedures where doctors can fix or replace a leaky heart valve using small tubes inserted through blood vessels, rather than open-heart surgery.
Will I receive a special treatment if I join?
You will receive one of the new tricuspid valve 'keyhole' treatments that your heart specialist team has already decided is suitable for you.
How long will the study last for me?
The study aims to follow patients from December 2024 to March 2028, with assessments at the start and at follow-up visits during this period.
Who is paying for this study?
The study is being funded by Edwards Lifesciences, a medical technology company, and the British Heart Foundation, a UK charity.
How to find out more
Benedict McDonaugh
Always speak to your GP or specialist before deciding to take part in a study.
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