Active not recruitingNAINTERVENTIONAL

Evaluation of Safety and Performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega™ Delivery System in Patients With Non-Valvular Atrial Fibrillation and High Bleeding Risk

This study is investigating a new implant called the Omega LAA Occluder. This device is designed for people who have an irregular heartbeat called non-valvular atrial fibrillation (NVAF). NVAF can increase the risk of strokes, and usually, blood-thinning medicines are prescribed to help prevent them. However, some people might have a high risk of bleeding, making these medications less suitable. The Omega LAA Occluder aims to close off a small pouch in the heart called the left atrial appendage, where blood clots often form, reducing stroke risk. This study will ensure the device is safe and works well for patients who are at high risk of bleeding and can't take traditional blood thinners.

At a glance

Status

Active not recruiting

Phase

Sponsor

Eclipse Medical Ltd.

Enrolment target

200

Start

17 Nov 2020

Estimated completion

07 Jan 2027

Non-Valvular Atrial Fibrillation

What is this study about?

This study is about a new medical device called the Omega LAA Occluder. 'LAA' stands for Left Atrial Appendage, which is a small, ear-shaped pouch that sticks out from the left side of the heart. For people with a condition called non-valvular atrial fibrillation (NVAF), blood can sometimes pool and form clots in this pouch. If these clots break off, they can travel to the brain and cause a stroke. Usually, to prevent strokes in NVAF, doctors prescribe blood-thinning medications. However, these medications can increase the risk of serious bleeding for some people.

This new device, the Omega LAA Occluder, is designed to be a permanent implant that closes off this left atrial appendage. It's inserted using a special delivery system in a procedure called a percutaneous insertion, which means it's done through a small cut in the skin rather than open surgery. The main goal of this study is to carefully check if this device is safe for patients and if it successfully reduces the risk of stroke in people with NVAF who are at a high risk of bleeding or who have had a stroke despite being on blood thinners.

Researchers are evaluating the Omega LAA Occluder based on previous lab tests and information from similar devices. This helps them understand whether it can be a good option for preventing strokes for people who cannot safely take traditional blood-thinning medications.

Key takeaways

Tests a new implant to prevent strokes in people with an irregular heartbeat (atrial fibrillation).
Aims to help those who can't take blood thinners due to high bleeding risk.
The device closes off a small heart pouch where clots can form.
The procedure is done minimally invasively, without open surgery.
The study assesses how safe and effective the device is.

Who may be eligible?

To be considered for this study, you need to be aged 18 or over and have a type of irregular heartbeat called non-valvular atrial fibrillation. You must also be at an increased risk of stroke. It's important that your heart's anatomy is suitable for this specific device and procedure, and you should be able and willing to take any necessary medicines after the implant and give your informed consent.

There are several reasons why you might not be able to join the study. For example, if you need to take blood-thinning medication long-term for another condition, or if you're allergic to common blood thinners like aspirin, clopidogrel, or warfarin. People who have active infections, certain heart conditions (like a recent stroke or heart attack, or severe heart failure), or a very short life expectancy due to another illness won't be eligible. Also, if there's any existing blood clot in your heart, or if you're pregnant or planning to be, you wouldn't be able to participate. The study also cannot accept you if you are already involved in another clinical study that might affect the results of this one.

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 non-valvular atrial fibrillation?
Are you at an increased risk of stroke?
Is your heart considered suitable for this type of implant procedure?
Can you follow a medication plan after the implant?
Do you not regularly need blood thinners for another health condition?

Answer every question to see your result.

What does participation involve?

If you participate in this study, you would undergo a procedure to implant the Omega LAA Occluder. This is a percutaneous procedure, meaning it's done via a small incision, typically in the groin, with guidance from imaging scans. You would need to follow a specific medication plan after the device is implanted to ensure its success and your safety. This involves taking certain medications as prescribed by the study doctors. There will be regular follow-up appointments with the study team to monitor your health, check the device's performance, and assess for any side effects. The total duration of your participation in the study, including these follow-up visits, would be explained to you in detail before you decide to join.

Potential risks and benefits

Participating in this study could potentially offer the benefit of a new way to reduce your stroke risk if you have non-valvular atrial fibrillation and cannot safely take traditional blood-thinning medications. However, like any medical procedure, there are potential risks, including those associated with the implantation procedure itself, such as bleeding, infection, and potential complications related to the heart. The study team will explain these risks thoroughly. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (13)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Rigshospitalet, Kardiologisk klinik B 2011
Verified postcode
Copenhagen, Denmark
Aarhus University Hospital
Verified postcode
Aarhus, Denmark
CardioVasculäres Centrum, Seckbacher Landstrasse 65
Verified postcode
Frankfurt, Germany
Charité - University Medicine Berlin - Campus Benjamin Franklin
Verified postcode
Berlin, Germany
Herzzentrum Leipzig
Verified postcode
Leipzig, Germany
Cardioangiologisches Centrum Bethanien
Verified postcode
Frankfurt, Germany
Mater Private Network
Verified postcode
Dublin, Ireland
Università Campus Biomedico Roma
Verified postcode
Rome, Italy
Instituto de Ciencias del Corazón (ICICOR) . Hospital Clínico Universitario
Verified postcode
Valladolid, Spain
Hospital Clinico San Carlos
Verified postcode
Madrid, Spain
Complejo Hospitalario de Salamanca
Verified postcode
Salamanca, Spain
Hospital de la Santa Creu I Sant Pau
Verified postcode
Barcelona, Spain

Common questions

What is non-valvular atrial fibrillation?

Non-valvular atrial fibrillation is an irregular and often rapid heart rate that isn't caused by a problem with one of your heart valves. It can increase your risk of stroke.

Why is the Omega LAA Occluder needed?

It's for people with non-valvular atrial fibrillation who are at high risk of stroke but also have a high risk of bleeding, making traditional blood-thinning medications unsuitable or dangerous for them.

What does 'percutaneous insertion' mean?

It means the device is put into your heart using thin tubes (catheters) inserted through a small cut in your skin, typically in your groin, rather than through open-heart surgery.

Will I need to take medication after the device is implanted?

Yes, you would need to follow a specific medication regimen after the procedure to help ensure the device works correctly and to prevent blood clots from forming on it initially.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time, for any reason, and this will not affect your future medical care.