RecruitingOBSERVATIONAL

Hamburg TranscathEteR Mitral Valve REplacement RegiStry

The HERMES study is watching how people with a heart problem called mitral valve disease do after being considered for a new treatment. This treatment, called transcatheter mitral valve replacement (TMVR), changes a faulty heart valve without major open-heart surgery. Researchers want to see how well these new valves work over time and if they last. They are also comparing TMVR to other common ways to treat mitral valve disease, such as repair surgery or medication. The study includes people who are over 18 and have significant mitral valve disease, especially if they are not good candidates for traditional surgery. The goal is to understand the best ways to help people with this condition.

At a glance

Status

Recruiting

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Enrolment target

300

Start

08 Mar 2021

Estimated completion

31 Dec 2030

Mitral Valve Disease

What is this study about?

Heart valves make sure blood flows in the right direction. The mitral valve is one of these, and sometimes it doesn't work well, letting blood leak backwards. This is called mitral valve disease. It's quite common, especially as people get older. For many, open-heart surgery can fix or replace this valve. However, some people are too frail or have other health problems that make surgery very risky. In these cases, doctors look for other options.

One newer option is called transcatheter mitral valve replacement (TMVR). Instead of opening the chest, doctors use a thin tube (catheter) to guide a new valve into place. This is a less invasive way to replace the valve. The HERMES study is a registry, which means it's collecting information over time from people who are being screened for this TMVR procedure. They want to see how these new valves work in the short term and the long term. Are they durable? Do they continue to function well?

This study is important because it will help doctors understand which treatments work best for different patients with mitral valve disease. It's looking at people who might not be able to have traditional surgery or other less invasive repairs. By collecting this information, doctors can make better decisions about care and improve the lives of patients with this heart condition.

Key takeaways

This study looks at a heart condition called mitral valve disease.
It focuses on a new procedure called TMVR that replaces a heart valve without open-heart surgery.
Researchers want to see how well these new valves work over time.
The study also compares TMVR to other treatment options.
It aims to help doctors make better decisions for patients with this condition.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have been diagnosed with a significant problem with your mitral heart valve. You would also be going through the process where doctors check if you are suitable for the new TMVR valve procedure.

You must be able to understand the study information and give your consent in writing, showing you agree to take part. It's also important that you can speak German well enough to understand the study documents and answer questions without needing a translator.

People who cannot understand the study materials in German or are physically or mentally unable to cooperate with the study's requirements would not be able to participate. This ensures everyone taking part fully understands what they are agreeing to.

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?
Do you have a significant mitral valve heart problem?
Are you currently being assessed for the TMVR procedure?
Can you understand information and respond in German without a translator?
Are you able to participate in follow-up appointments?

Answer every question to see your result.

What does participation involve?

This study is a registry, which means researchers will collect information about your health over time. You won't be given any new or experimental medications as part of this study. Instead, doctors will monitor your condition and the outcomes of your treatment (whether that's TMVR, another procedure, or medication) if you are being considered for TMVR.

Taking part would involve regular check-ups and assessments, just like you would normally have for your heart condition, perhaps with some extra questions or tests related to the study. The study aims to follow people long-term to understand how their valve treatment works out. The total duration of your participation could be many years, as they want to see how the new valves function over a very long time.

Potential risks and benefits

Participating in this study might help improve future treatments for people with mitral valve disease by providing doctors with valuable information about how different treatments work. However, joining the study doesn't offer direct medical benefits to you beyond the care you would already receive. As with any medical procedure, there are potential risks associated with the treatments themselves, but these are not new risks from the study itself. Any risks related to your treatment would be explained by your medical team. You are free to withdraw from the study at any time without it affecting your medical care.

Locations (1)

University Heart and Vascular Center Hamburg
Verified postcode
Hamburg, Germany· Recruiting

Common questions

What is mitral valve disease?

It's a heart condition where one of your heart valves, the mitral valve, doesn't work properly, often letting blood leak backwards instead of flowing forward as it should.

What is TMVR?

TMVR stands for transcatheter mitral valve replacement. It's a way to replace a faulty mitral valve using a thin tube inserted into a blood vessel, rather than open-heart surgery.

What will I have to do if I join the study?

You'll have your usual medical check-ups and assessments. The study will collect information about your health and the results of your heart treatment over time.

Will I get new experimental treatment?

No, this study is observing how current treatments, including TMVR, work for patients. You won't be given any experimental treatments as part of the study.

Can I leave the study at any time?

Yes, you have the right to withdraw from the study at any point, and your decision will not affect your medical care.

How to find out more

Sebastian Ludwig, MD

se.ludwig@uke.de +49-40-7410-0 Official trial record

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