RecruitingOBSERVATIONAL

The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry

This study, taking place in Germany, is for patients who have problems with their heart valves, specifically a leaky or narrowed mitral valve, or a leaky tricuspid valve. Doctors are looking at a treatment called 'edge-to-edge valve repair', which is a less invasive way to fix these valves without major open-heart surgery. They want to carefully watch how patients who have this procedure are doing in the long run. By collecting information on many patients over time, they hope to better understand how effective and safe this treatment is, and how it impacts people's health for many years after the procedure.

At a glance

Status

Recruiting

Sponsor

Deutsches Herzzentrum Muenchen

Enrolment target

5,000

Start

15 Sep 2020

Estimated completion

01 Jan 2031

Mitral Valve Regurgitation Mitral Valve Stenosis Tricuspid Valve Regurgitation

What is this study about?

Imagine your heart has doors, called valves, that open and close to keep your blood flowing in the right direction. Sometimes, these doors can become leaky (regurgitation) or too stiff and narrow (stenosis), making your heart work harder. This study focuses on people who have these kinds of problems with two main heart valves: the mitral valve and the tricuspid valve.

Doctors are interested in a special way to fix these valves that doesn't involve open-heart surgery. It's called 'edge-to-edge valve repair', and it's a way to mend the leaky or narrowed valve using a small tube inserted into a blood vessel. This study is like a careful observation project. Researchers are simply watching and keeping track of all patients who have this specific procedure at a hospital in Munich, Germany.

The main goal is to understand what happens to these patients in the long term after they've had the repair. They want to see how patients' health holds up over many years. By collecting this information from many people, doctors can learn more about how well this treatment works and continue to improve how they care for patients with heart valve problems.

Key takeaways

The study watches patients who have a specific heart valve repair in Germany.
It aims to understand long-term health after 'edge-to-edge valve repair'.
It focuses on leaky or narrowed mitral and tricuspid heart valves.
Participation involves allowing doctors to collect information from your usual medical care.
You won't receive extra treatments or procedures due to the study.
The study helps improve future care for people with similar heart valve issues.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old. You would also have to have a problem with one of your heart valves: either a leaky or narrowed mitral valve, or a leaky tricuspid valve. Importantly, a team of heart specialists must have decided that the 'edge-to-edge valve repair' is the best treatment option for you.

Before taking part, you would need to give your informed consent in writing. This means you understand what the study involves and agree to participate. You wouldn't be able to join if you couldn't fully cooperate with the study plan, for example, if you had other health issues that made it difficult to follow instructions or attend appointments.

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 at least 18 years old?
Do you have a leaky or narrowed mitral valve, or a leaky tricuspid valve?
Has a heart specialist team decided that 'edge-to-edge valve repair' is your best treatment option?
Are you willing and able to give your written consent to participate?
Are you able to cooperate with your normal medical follow-up appointments?

Answer every question to see your result.

What does participation involve?

This is an observational study, which means you wouldn't be given new medications or treatments specially for the study. Instead, researchers would collect information about your health before, during, and after your standard 'edge-to-edge valve repair' procedure. This would likely involve reviewing your medical records, including test results and doctor's notes, that are already part of your usual care. You might also be asked about your health during follow-up appointments, which would be part of your normal care after the procedure. The study aims to follow patients long-term, gathering information on how you are doing for many years after your valve repair. The exact number of visits or assessments would depend on your individual medical needs and your doctor's recommendations for follow-up care.

Potential risks and benefits

Because this is an observational study, it doesn't involve new treatments or procedures beyond your standard care, so there are no additional medical risks from the study itself. The benefits are mainly for general medical knowledge: by participating, you help doctors learn more about the long-term effects of this valve repair procedure, which can improve care for future patients. You have the right to withdraw from the study at any time without affecting your medical treatment.

Locations (1)

Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München
Verified postcode
Munich, Germany· Recruiting

Common questions

What kind of heart valve problems is this study looking at?

It's looking at problems where the mitral valve or tricuspid valve is either leaky (regurgitation) or too narrow (stenosis).

What is 'edge-to-edge valve repair'?

It's a procedure to fix a faulty heart valve using a less invasive approach, often through a small tube inserted into a blood vessel, rather than open-heart surgery.

Do I have to live in Germany to take part?

Yes, this study is being conducted at a specific hospital in Munich, Germany, for patients treated there.

Will I get special treatment in this study?

No, this is an observational study. You will receive the standard 'edge-to-edge valve repair' as recommended by your doctors, and the study will simply collect information about how you do.

What is the main purpose of this study?

The main purpose is to understand how patients are doing in the long term after 'edge-to-edge valve repair' for their heart valves.

How to find out more

Patrick Mayr, MD

mayrp@dhm.mhn.de +498912180 Official trial record

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