RecruitingOBSERVATIONAL

European Registry of Transcatheter Repair for Tricuspid Regurgitation

This study, called the EuroTR registry, is looking into new keyhole (transcatheter) treatments for a heart condition called tricuspid regurgitation. This is when a valve in your heart doesn't close properly, causing blood to leak backwards. This can lead to serious problems like heart failure. Traditionally, surgery for this condition can be risky, especially for very unwell patients. These new keyhole procedures offer a less invasive option for many. The study aims to collect information on how patients treated with these devices recover, their quality of life, and their survival rates. This information will help doctors understand which treatment works best for different patients in a real-world setting.

At a glance

Status

Recruiting

Sponsor

LMU Klinikum

Enrolment target

3,000

Start

23 Oct 2023

Estimated completion

31 Dec 2030

Tricuspid Regurgitation Valvular Heart Disease Heart Failure

What is this study about?

Imagine your heart as a house with four rooms and four doors, called valves. One of these doors, the tricuspid valve, helps blood flow in the right direction. If this door doesn't close properly, blood can leak backwards into the wrong room. This is called tricuspid regurgitation (TR), and it means your heart has to work much harder.

Over time, this extra work can weaken your heart, leading to symptoms like tiredness, breathlessness, and swelling in your legs. It can even lead to heart failure, which means your heart isn't pumping blood as well as it should. While there are medicines to help manage the symptoms, sometimes a more direct fix is needed.

In the past, surgery was the main way to fix this valve. However, surgery can be very difficult and risky for some patients, especially those who are already quite unwell. Now, new, less invasive treatments are available. These involve fixing or replacing the valve using special tools inserted through a small cut, usually in the leg, rather than opening up the chest. This study aims to gather important information on how these new 'keyhole' treatments work in everyday practice.

Key takeaways

This study collects real-world information on new keyhole heart valve treatments.
It helps doctors understand how well these safe procedures work for people with tricuspid regurgitation.
Your medical records and routine follow-ups provide the study information.
Participation helps improve care for future patients with similar heart conditions.
You must be 18 or older and have already had one of the specific keyhole valve treatments.
There are no additional medical procedures or risks beyond your standard care.

Who may be eligible?

To take part in this study, you would need to be an adult, 18 years old or older. Both men and women can be included.

The main thing is that you have received one of the new 'keyhole' treatments for your tricuspid valve. This study checks how well these specific treatments work after they've been used.

It's not about being given a new treatment you haven't had yet; it's about following people who have already had one of these specific devices (PASCAL, TriClip, TricValve, Evoque, or LuX-Valve) implanted to fix or replace their tricuspid valve.

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?
Have you recently had a keyhole procedure to fix or replace your tricuspid valve?
Did you receive one of these specific devices: PASCAL, TriClip, TricValve, Evoque, or LuX-Valve?
Are you happy for your medical information from your standard care to be used for research?

Answer every question to see your result.

What does participation involve?

This study is a registry, which means it collects information over time from people who have already had a specific treatment. You wouldn't be given a new medicine or treatment just for the study. Instead, the doctors would collect information about your health, recovery, and any follow-up appointments you have after your tricuspid valve procedure. This typically involves reviewing your medical records, including information from your hospital stay and routine check-ups. The doctors would be interested in how you are feeling, your symptoms, and how well your new valve is working over time. The total duration of your participation would depend on how long the registry decides to follow people after their procedure.

Potential risks and benefits

The main benefit of taking part in this study is that the information collected from people like you will help doctors understand these new treatments better. This will enable them to make more informed decisions about which treatment is best for future patients with similar heart problems. Since this is a registry, there are generally no additional risks beyond the usual risks associated with your heart procedure and follow-up care that you would receive anyway. You have the right to withdraw your consent to have your information included in the registry at any time, without it affecting your medical care.

Locations (1)

LMU Klinikum
Verified postcode
Munich, Germany· Recruiting

Common questions

What is tricuspid regurgitation?

It's a heart condition where a valve in your heart (the tricuspid valve) doesn't close properly, causing blood to leak backwards.

What are 'keyhole' treatments?

These are less invasive procedures where doctors fix or replace heart valves using special tools inserted through a small cut, often in the leg, instead of open-heart surgery.

Will I get a new treatment if I join this study?

No, this study is for people who have already had one of the specific keyhole tricuspid valve treatments. It follows your progress after that.

Is this study safe?

Yes, because it mostly involves collecting information from your existing medical records and follow-up, there are typically no additional risks beyond your standard care.

What is the purpose of this study?

The study aims to see how well these new keyhole treatments for tricuspid regurgitation work in real-world patients over time, to help doctors treat future patients better.

How to find out more

Jörg Hausleiter, Prof. Dr.

joerg.hausleiter@med.uni-muenchen.de +49 89 4400 72360 Official trial record

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