RecruitingOBSERVATIONAL

Post-marketing Clinical Study of the LAMBRE System for Left Auricle Closure

This study is about a medical device called LAMBRE, which is used to prevent strokes in people who have a heart rhythm problem called atrial fibrillation. In atrial fibrillation, tiny blood clots can form in a part of the heart called the left atrium, which can then travel to the brain and cause a stroke. Usually, blood-thinning medicines are used to prevent this. However, some people can't take these medicines because they might cause serious bleeding. For these individuals, a LAMBRE device can be implanted to seal off the part of the heart where clots usually form. This study is checking how well the LAMBRE device works and if it stays securely in place after it's been put in. The results will help decide if the device should continue to be available in France.

At a glance

Status

Recruiting

Sponsor

French Cardiology Society

Enrolment target

220

Start

10 Jun 2024

Estimated completion

01 Dec 2027

Atrial Fibrillation

What is this study about?

If you have a heart condition called atrial fibrillation, your heart beats irregularly. This can sometimes lead to blood clots forming in a small pouch on the left side of your heart, called the left atrial appendage. These clots can then travel to your brain and cause a stroke. To prevent this, doctors usually prescribe blood-thinning medicines.

However, for some people, these blood-thinning medicines aren't suitable. This might be because they have a very high risk of serious bleeding. In these situations, your doctor might suggest a procedure to close off that pouch in your heart using a special device. The LAMBRE device is one such option. It's designed to seal off the left atrial appendage, helping to stop blood clots from forming and reducing your risk of stroke.

This study is specifically looking at how well the LAMBRE device works and how safe it is after it's been used in real patients. It's especially interested in whether the device stays in the correct place once implanted. The information gathered from this study will help health authorities decide if the LAMBRE device should continue to be available for patients who need it.

Key takeaways

This study is about a device to prevent strokes in people with atrial fibrillation.
It's for people who can't take blood thinners due to bleeding risks.
The LAMBRE device seals off a part of the heart where clots can form.
The study checks how well the device works and stays in place over time.
Participation involves sharing medical information from your routine care, not extra procedures.

Who may be eligible?

This study is for adults aged 18 or over.

You might be able to take part if your doctor feels that closing off the left atrial appendage with a LAMBRE device is the right treatment for you, based on specific health guidelines. This would typically be because you have atrial fibrillation, a high risk of stroke, and cannot safely take blood-thinning medicines.

You won't be able to join the study if you are under 18, or if you are unable or unwilling to give your consent (permission) to participate, for example, if you have a legal guardian who cannot agree on your behalf.

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 atrial fibrillation?
Has my doctor said I have a high risk of stroke?
Am I unable to take blood-thinning medicines because they are too risky for me?
Is my doctor recommending a procedure to close off the left atrial appendage?
Am I 18 years old or older?

Answer every question to see your result.

What does participation involve?

This study is 'non-interventional', which means it mainly involves looking at your existing medical records and information that would be collected as part of your standard medical care. You won't be asked to have extra tests or procedures specifically for the study.

After your LAMBRE device is put in, your medical team will continue to monitor you as they normally would. The study will collect information from these routine check-ups and your health over time. There won't be specific study visits or extra medication to take. The total duration of your participation in terms of data collection will depend on your medical follow-up, but it mainly involves reviewing information that is already being collected about your health.

Potential risks and benefits

The main benefit of taking part in this study is that you are helping medical professionals understand more about the effectiveness and safety of the LAMBRE device. This can improve care for future patients. For you directly, you would already be undergoing the LAMBRE procedure as part of your necessary medical treatment. The risks associated with the LAMBRE device implantation itself would be fully explained by your doctor before your procedure, and these are separate from participation in this study, which simply observes the outcomes. There are no additional risks from participating in the study as it only involves data collection from your routine care. You are always free to withdraw your consent from the study at any time without affecting your medical treatment.

Locations (1)

Hôpital Cardiologique de Haut Lévêque
Verified postcode
Pessac, France· Recruiting

Common questions

What is atrial fibrillation?

It's a common heart condition where your heart beats irregularly, which can increase your risk of stroke.

What is the LAMBRE device?

It's a medical implant that seals off a small pouch in your heart where blood clots can form, helping to prevent strokes.

Why would someone need a LAMBRE device?

It's an option for people with atrial fibrillation who need stroke prevention but can't safely take blood-thinning medicines because of bleeding risks.

Will I have extra appointments if I join this study?

No, this study uses information from your regular medical care. You won't have any additional appointments or tests beyond what your doctor already recommends.

Is the LAMBRE device already used in the UK?

This study specifically mentions its use and review in France. Your doctor would be able to advise on its availability and suitability in the UK.

How to find out more

Dr Xavier IRIART

escalle@sfcardio.fr (+33) 1 44 90 70 29 Official trial record

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