RecruitingOBSERVATIONAL

German Registry for Transcatheter Tricuspid Valve Interventions

This study, called the "German Registry for Transcatheter Tricuspid Valve Interventions," is looking at new treatments for a heart condition called severe tricuspid regurgitation. This is where a valve in the heart (the tricuspid valve) doesn't close properly, letting blood leak backwards. This condition can make people very unwell. While open-heart surgery is often recommended, many patients are too sick for this kind of operation. So, doctors have developed new, less invasive ways to fix the valve. This study is collecting information from many hospitals to understand how successful and safe these new treatments are. It's helping doctors learn more about who benefits most from these procedures.

At a glance

Status

Recruiting

Sponsor

LMU Klinikum

Enrolment target

600

Start

01 Oct 2020

Estimated completion

31 Dec 2030

Tricuspid Regurgitation Tricuspid Valve Insufficiency Heart Valve

What is this study about?

You might have heard of a heart condition called tricuspid regurgitation. This happens when one of the heart's valves, called the tricuspid valve, doesn't close tightly enough. This means that when your heart pumps, some blood leaks backward through the valve instead of flowing forward. When this leaking is severe, it's known as severe tricuspid regurgitation, and it can make you feel very tired and short of breath, and can be quite serious if not treated.

Traditionally, the main treatment for severe tricuspid regurgitation has been open-heart surgery to repair or replace the valve. However, for many people, this surgery can be too risky, perhaps because they have other health problems or are elderly. In these cases, doctors have been developing new, less invasive procedures that don't require major open-heart surgery. These are called 'interventional treatments' and involve using special tools guided through blood vessels to fix the valve.

This study is called the "German Registry for Transcatheter Tricuspid Valve Interventions." It's like a large collection of information from many different hospitals in Germany. The main goal is to carefully watch and record how well these new interventional treatments work for patients with severe tricuspid regurgitation. Researchers want to understand if these treatments are successful in helping patients feel better and if they are safe. By collecting detailed information over time, they hope to improve care for people who can't have traditional surgery.

Key takeaways

Looks at new, less invasive treatments for a heart problem.
Focuses on a condition called severe tricuspid regurgitation.
Helps patients who can't have traditional heart surgery.
Collects real-world information on how well treatments work.
Aims to improve future care for heart valve patients.

Who may be eligible?

To be considered for this study, you would need to be an adult, 18 years old or older. The main requirement is that you are going to have, or have recently had, an interventional treatment for severe tricuspid regurgitation using a special device that has been approved for use.

You cannot take part in this study if you are under 18 years old or if you simply do not wish to participate. Before joining, you would also need to fully understand what the study involves and agree to take part by signing a consent form.

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 or planning to have a 'keyhole' procedure for your tricuspid valve?
Has the device used for your procedure been approved for use?
Are you willing to share your medical information for the study?

Answer every question to see your result.

What does participation involve?

This is an observational study, which means it mostly involves collecting information during your standard medical care rather than you receiving new or experimental treatments just for the study. You would receive the tricuspid valve treatment as planned with your doctor. Researchers would then gather information from your medical records, including details about your health before the procedure, results from your echocardiograms (heart scans), and blood tests. They would continue to collect this information over time during your regular follow-up appointments to see how you are doing after the treatment. There are no extra visits or medications specifically for the study. The total duration of your participation would depend on how long the researchers choose to follow patients in the registry.

Potential risks and benefits

Since this is an observational study of treatments you would already be receiving, there are no specific new risks associated with participating in the study itself beyond the usual risks of your medical care and the tricuspid valve intervention. The potential benefit is that by sharing your health information anonymously, you're helping doctors learn more about the success and safety of these new treatments, which can improve care for future patients. You are free to withdraw your consent and stop participating in the study at any time without it affecting your medical care.

Locations (1)

Klinikum der LMU Muenchen
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, letting blood leak backward.

Is this a study about new medicines?

No, it's about new procedures or devices used to fix the tricuspid valve without major open-heart surgery.

Do I have to do anything extra if I join?

No, this study mainly collects information from your regular care and appointments. There are no extra visits just for the study.

Why is this study important?

It helps doctors learn how well and how safely these new heart procedures work, especially for patients who can't have traditional surgery.

Who is running this study?

It's a German registry involving multiple hospitals, collecting data on specific heart valve interventions.

How to find out more

Jörg Hausleiter, MD

joerg.hausleiter@med.uni-muenchen.de +49 89 4400 72361 Official trial record

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