Evaluation of the Impact of Interventional Treatments for Symptomatic, Severe Tricuspid Valve Insufficiency on Renal Integrity and Function, as Well as on Physical Function and Activity in Older Adults.
This research is investigating a treatment for a common heart problem called tricuspid valve insufficiency, where a valve in the heart doesn't close properly, causing blood to leak backward. This can lead to swelling and make you feel tired. We're specifically looking at how a keyhole procedure, called Transcatheter Edge-to-Edge Repair (TEER), might help people, especially older adults. The main aim is to see if this treatment not only fixes the leaky valve but also improves kidney function. We'll also check if it reduces swelling, eases symptoms, and helps people become more active and improve their quality of life. This study hopes to show that fixing the heart valve can have wider benefits for your body and daily living.
At a glance
What is this study about?
This study is all about a common heart condition called tricuspid valve insufficiency. Imagine one of the 'doors' (valves) in your heart doesn’t close properly, allowing blood to flow backward. This can make your heart work harder and lead to symptoms like swelling, especially in your legs, and feeling very tired. Over time, this can also affect other organs, like your kidneys.
We are looking at a treatment called Transcatheter Edge-to-Edge Repair (TEER). This is a less invasive procedure, often done through a small tube inserted into a blood vessel, rather than open-heart surgery. The idea is to help the leaky valve close better. For this study, we want to understand how this treatment helps older adults with severe symptoms.
Specifically, we want to see if fixing the leaky heart valve can also improve your kidney health. We're also keen to find out if it reduces swelling, makes your symptoms less bothersome, and improves your ability to do daily activities like walking and moving around. Ultimately, we hope to see if this treatment can significantly improve your overall quality of life.
Key takeaways
- This study looks at a keyhole procedure for a leaky heart valve.
- It aims to see if this treatment also improves kidney health.
- Researchers will check if it reduces swelling and boosts daily activity.
- The study focuses on older adults with severe symptoms.
- It could potentially improve your overall quality of life.
Who may be eligible?
To be considered for this study, you would generally need to have severe symptoms from a leaky tricuspid heart valve and be referred by your doctor for a specific type of treatment called TriClip/TricValve. You must be at least 18 years old and able to understand and agree to take part in the study. You should also be able to walk short distances, even if you need aids like a walking stick.
However, there are reasons why you might not be able to join. For example, if you are undergoing regular dialysis for severe kidney failure, you wouldn't be suitable. Similarly, if you have conditions like severe dementia that would make it difficult to follow the study's requirements, or if you have very low blood iron levels (severe anaemia), you wouldn't be able to participate. The study is not for those receiving this treatment just to make them more comfortable if they are very unwell, or if you choose not to give your permission.
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 symptoms from a leaky tricuspid heart valve?
- Are you at least 18 years old?
- Can you walk short distances, even with help?
- Are you able to understand and agree to participate in a study?
- Are you NOT currently undergoing dialysis for kidney failure?
- Do you NOT have severe problems like dementia that would make it hard to follow study instructions?
What does participation involve?
If you decide to take part, you'll first have some assessments to see if you're suitable. If you are, you'll undergo the tricuspid valve treatment. After the procedure, there will be follow-up appointments where we'll check your health, kidney function, and how you're feeling. This will likely involve health checks, blood tests, and possibly questionnaires about your daily activities and quality of life. The exact number of visits and the total duration of your participation will be explained in detail by the study team, but generally, studies like this involve regular check-ups over several months to monitor your progress.
Potential risks and benefits
Locations (1)
- Robert Bosch HospitalVerified postcodeStuttgart, Germany· Recruiting
Common questions
What is a tricuspid valve?
It's one of the four valves in your heart, acting like a one-way door to control blood flow between two of your heart's chambers.
What does 'insufficiency' mean for a valve?
It means the valve doesn't close properly, allowing some blood to leak backward, which makes your heart work harder.
What is TEER?
TEER stands for Transcatheter Edge-to-Edge Repair. It's a keyhole procedure to help your leaky heart valve close better.
Will this treatment cure my condition?
This treatment aims to improve the function of your valve and alleviate symptoms, which can significantly improve your quality of life, but it may not be a complete 'cure'.
How long will I be in the study?
The study team will give you a detailed timeline, but it usually involves several months of follow-up after the initial treatment.
How to find out more
Andrea Schwab
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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