Not yet recruitingOBSERVATIONAL

The EMBRACE Registry: European Post-Market Registry for Catheter Based Mitral Valve Replacement

This study, called 'The EMBRACE Registry,' is looking at a new treatment for a common heart problem called mitral regurgitation, where the heart's mitral valve doesn't close properly, causing blood to leak backward. The treatment involves a device called the HighLife transcatheter mitral valve replacement system. This registry isn't a traditional 'trial' testing a new drug; instead, it's tracking how this approved device performs in real-world patients after it's been made available for use. Doctors want to understand how effective and safe it is for people who can't have traditional open-heart surgery for their leaky valve or other catheter-based repairs. Participation is voluntary, and the study aims to gather important details to help improve care.

At a glance

Status

Not yet recruiting

Sponsor

HighLife SAS

Enrolment target

150

Start

14 Mar 2026

Estimated completion

15 Apr 2031

Mitral Regurgitation

What is this study about?

Imagine your heart is a house with several doors, and one of these doors, called the mitral valve, isn't closing properly. This causes blood to leak back into the wrong part of the heart, a condition known as mitral regurgitation. This can make your heart work harder and lead to symptoms like breathlessness or tiredness. Usually, doctors can fix or replace this valve with surgery.

However, for some people, open-heart surgery is too risky or not possible. There are also other keyhole procedures that might not be suitable if the valve's shape is tricky. That's where a new device called the HighLife transcatheter mitral valve replacement system comes in. It's a way to replace the leaky mitral valve using a thin tube (catheter) inserted through a blood vessel, avoiding major surgery.

This 'EMBRACE Registry' isn't about testing if the HighLife device works – it's already been approved for use. Instead, it's like keeping a careful eye on how the device performs in people who are actually receiving it in hospitals, in their everyday care. This helps doctors learn more about its long-term effects and how people get on with it after it's been released for general use. It's a way to gather important information to ensure this new treatment option continues to be safe and effective for patients.

Key takeaways

This study tracks the HighLife device for a leaky heart valve.
It's for people who can't have traditional heart surgery.
It's a 'registry' to learn more about the device in real-world use.
Participation involves sharing your medical information, not receiving experimental treatment.
A team of heart specialists must agree the device is right for you.
You can withdraw from the registry at any time.

Who may be eligible?

To be considered for this registry, you would typically have a severe or moderately severe leaky mitral valve, whether it's due to age-related wear and tear or other heart conditions. Your heart's pumping strength should be at least 30%, and a specific heart measurement (LVEDD) shouldn't be above 70mm.

Crucially, a team of heart specialists must agree that traditional open-heart surgery for your valve, or another keyhole repair method, isn't suitable for you. They also need to confirm that the HighLife device is a good fit for your specific heart condition and anatomy, following its approved guidelines.

There are also reasons why you might not be able to join. For example, if your mitral valve or surrounding areas are very hardened with calcium, if your leg arteries are too narrow for the delivery tubes, or if you have certain allergies (like to materials in the device or contrast dyes used in scans). If you have an active infection, a history of certain heart implants, or are already in another study that might affect follow-up, you might also be excluded.

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.

Do I have a severe or moderately severe leaky heart valve?
Has my heart team said open-heart surgery or other keyhole repairs aren't suitable for me?
Has my heart team decided the HighLife device could be a good option for me?
Do I have any severe hardening (calcification) around my mitral valve?
Do I have any active infections?
Am I willing to have my medical information followed regularly?

Answer every question to see your result.

What does participation involve?

Joining this registry means that if your doctors decide the HighLife device is the best treatment for your leaky mitral valve, your information will be collected and followed over time. You won't be given any new or experimental treatments – you'll be receiving the HighLife device as part of your standard care. The study will mainly involve collecting data from your medical records, including details about your procedure, your recovery, and how you are feeling during your regular follow-up appointments. This doesn't usually involve extra hospital visits or special tests beyond what your doctor would normally recommend for your condition. The full duration of follow-up for this registry isn't specified, but it generally involves checking in at regular intervals after your procedure.

Potential risks and benefits

Participating in this registry means doctors will carefully track your progress after receiving the HighLife device, which could contribute to a better understanding of this treatment for others in the future. The device itself carries potential risks, as do all medical procedures, but these would be discussed in detail by your healthcare team before treatment. There are no additional risks directly linked to being in the registry, beyond those of receiving the treatment itself. Remember, all participation is voluntary, and you can withdraw your consent for your data to be used at any time without affecting your medical care.

Locations (1)

Universitätsklinikum Ulm
Verified postcode
Ulm, Germany

Common questions

What is a 'registry' study?

A registry is like a large record-keeping system. It collects information about how a medical device or treatment performs in real patients after it has been approved for use, rather than testing it for the first time.

Will I receive a special treatment as part of this study?

No, you will receive the HighLife device as part of your normal medical care, not as part of an experiment. The study simply collects information about your progress after receiving it.

What is mitral regurgitation?

Mitral regurgitation is a condition where the mitral valve in your heart doesn't close properly, causing blood to leak backward. This can make your heart work harder.

Who is the HighLife device for?

It's for people with a leaky mitral valve who are considered too risky for traditional open-heart surgery or other catheter-based repairs, and whose heart team believes this device is suitable for them.

Can I leave the registry if I change my mind?

Yes, your participation is completely voluntary. You can decide to stop being part of the registry at any time without it affecting your medical care.

How to find out more

Vanessa Gallois

vgallois@highlifemed.com +33 6 68 77 34 77 Official trial record

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