RecruitingOBSERVATIONAL

The Prospective Segeberg Registry for Mitral Transcatheter Edge-to-Edge Repair

This study, based in Bad Segeberg, Germany, is designed to keep track of patients who have a significant heart condition called severe mitral regurgitation, often known as a leaky heart valve. These patients are undergoing a keyhole procedure called Transcatheter Edge-to-Edge Repair (M-TEER) to help fix their valve. The study aims to understand how these patients fare after their treatment, following them up regularly with check-ups. By collecting information on their health journey, doctors hope to learn more about the long-term effects and success of this specific heart procedure. It's a straightforward registry, meaning it simply observes and records patient progress over time.

At a glance

Status

Recruiting

Sponsor

Segeberger Kliniken GmbH

Enrolment target

2,000

Start

01 Jan 2011

Estimated completion

31 Dec 2032

Mitral Regurgitation (MR)

What is this study about?

This study is called 'The Prospective Segeberg Registry for Mitral Transcatheter Edge-to-Edge Repair'. That's a bit of a mouthful, so let's break it down. It's looking closely at people who have a heart condition called `mitral regurgitation`, which simply means one of the valves in their heart (the mitral valve) isn't closing properly. This causes blood to flow backwards, making the heart work harder. If this problem is severe, doctors might suggest a procedure called `Transcatheter Edge-to-Edge Repair`, often shortened to M-TEER.

This M-TEER procedure is a way to fix the leaky valve without open-heart surgery. Instead, doctors use a special catheter (a thin, flexible tube) to reach the heart and place clips on the valve flaps to help them close better. This study in Germany is essentially a detailed follow-up programme for everyone who undergoes this specific procedure at their Heart Center in Bad Segeberg. They are collecting information on how patients recover and how well the treatment works over time.

The main goal of this study is to gather real-world information on the M-TEER procedure. By carefully observing patients and their health over months and years, doctors can better understand the long-term benefits and any potential challenges of this treatment. This information is really important because it helps them improve care for future patients with similar heart conditions.

Key takeaways

This study tracks patients getting a keyhole heart procedure (M-TEER).
It aims to understand how well patients do over time after treatment for a leaky heart valve.
Participation involves sharing information from your regular medical check-ups.
You won't have extra tests or take new medications for the study.
The information helps improve future care for people with heart valve problems.

Who may be eligible?

This study is for adults who are receiving the M-TEER procedure for a severe leaky heart valve. People between the ages of 18 and 100 years old, regardless of whether they are male or female, can be included.

The main thing that makes someone eligible is that they are already scheduled to have, or have just had, this specific heart procedure to fix their leaky mitral valve because the problem is quite serious.

There aren't any specific reasons listed that would prevent someone from joining this particular study, as long as they are undergoing the M-TEER procedure for severe mitral regurgitation.

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.

Am I having, or have I recently had, the M-TEER procedure?
Is my mitral regurgitation considered severe by my doctor?
Am I 18 years old or older?
Am I receiving treatment at the Heart Center, Bad Segeberg, Germany (or a similar centre if this study were elsewhere)?

Answer every question to see your result.

What does participation involve?

If you take part in this registry, it means doctors will collect information about your health during your standard hospital visits and check-ups after your M-TEER procedure. You won't be asked to take any new medications because of the study, nor will you undergo any extra tests that aren't already part of your usual care. The main commitment is simply allowing your health information, including details from your routine long-term follow-up appointments, to be recorded and studied. The total duration of your participation will depend on how long your doctors typically follow up with patients after this procedure, which can be for several years.

Potential risks and benefits

The main benefit of taking part in this study is that the information collected from your experience, along with many others, will help doctors better understand the M-TEER procedure and improve care for future patients with leaky heart valves. Since this study only involves collecting data from your routine medical care after your procedure, there are no additional risks directly linked to being in the study itself. You won't be asked to do anything you wouldn't normally do as part of your treatment. However, it's important to remember that all medical procedures, including the M-TEER, carry some risks, which your doctor will discuss with you. You always have the right to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Herzzentrum Segeberger Kliniken GmbH
Verified postcode
Bad Segeberg, Germany· Recruiting

Common questions

What is mitral regurgitation?

It's a condition where one of the heart's valves, the mitral valve, doesn't close properly, causing blood to leak backwards.

What is the M-TEER procedure?

It's a keyhole procedure that uses small clips to help fix a leaky mitral heart valve without major surgery.

Do I have to take new medicines for this study?

No, you won't be asked to take any new medications because of this study. You'll just continue with your usual prescribed medicines.

Will I have extra doctor's appointments?

No, this study uses information from your normal, routine follow-up appointments after your procedure. There are no extra visits.

Can I stop participating in the study if I change my mind?

Yes, you can decide to stop being part of the study at any time, and it will not affect your medical care.

How to find out more

Arief Kurniadi, MD

arief.kurniadi@segebergerkliniken.de +4945512802 Official trial record

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