RecruitingNAINTERVENTIONAL

Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease

This research study is for people who have an irregular heartbeat called atrial fibrillation (AF) and also severe kidney disease. AF can increase the risk of strokes. This study investigates a procedure called Left Atrial Appendage (LAA) closure. This involves using a small device to block off a small pouch in the heart where blood clots often form, which can then travel to the brain and cause a stroke. Researchers want to see if closing this pouch is more effective or safer than current usual care for preventing strokes in people who also have end-stage kidney disease. The study compares the LAA closure device with the best available medical treatments, which might include different blood-thinning medications or no medication if bleeding risk is very high.

At a glance

Status

Recruiting

Phase

Sponsor

Prof. Dr. med. Ingo Eitel

Enrolment target

430

Start

28 Mar 2022

Estimated completion

14 Jan 2028

Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent

What is this study about?

This study is looking into a treatment option for people who have two serious health conditions: an irregular heartbeat called atrial fibrillation (AF), and severe kidney disease, also known as end-stage kidney disease. Atrial fibrillation can make blood collect and form clots in a small part of the heart called the left atrial appendage (LAA). If these clots break free and travel to the brain, they can cause a stroke.

People with severe kidney disease often have a higher risk of both strokes and serious bleeding, which makes it tricky for doctors to decide on the best way to prevent strokes. Current treatments for stroke prevention in AF often involve blood-thinning medications, but these can increase the risk of bleeding, especially in people with kidney problems.

This study is testing a procedure called LAA closure. During this procedure, a small device is inserted into the LAA to seal it off, preventing clots from forming or escaping. The researchers want to find out if this procedure is a better or safer way to prevent strokes for people with AF and end-stage kidney disease compared to the best current medical care, which might involve different types of blood thinners or other treatments.

Key takeaways

The study explores a new way to prevent strokes in people with irregular heartbeats and severe kidney disease.
It compares a heart procedure (LAA closure) to standard medical care.
Participation involves being randomly assigned to one of the treatment groups.
Joining the study is entirely voluntary and you can withdraw at any time.
The goal is to find safer and more effective treatment options for this high-risk group.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have a diagnosed irregular heartbeat called non-valvular atrial fibrillation (this includes different types like paroxysmal, persistent, or permanent AF). You also need to have severe kidney disease, specifically what doctors call 'stage 5 chronic kidney disease,' where your kidneys aren't working well, even if you are on dialysis.

The research team will also check a risk score called CHA2DS2VASc, and you would need a score of 2 or more, which means you have a higher risk of stroke. Importantly, you must be able to understand the study and provide your informed consent to take part.

There are also reasons why you might not be able to join. For example, if you are pregnant, under 18, or if you have certain other conditions like a blood clot already in your heart's left atrial appendage, or if you are already taking blood thinners for a different heart problem (like a mechanical heart valve). People who have certain medical conditions that mean they can't take aspirin or clopidogrel (common medications) also wouldn't be able to participate, or if your doctors expect you to live less than 2 years.

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 a current diagnosis of non-valvular atrial fibrillation?
Do you have severe (stage 5) chronic kidney disease?
Are you able to provide your consent to be in a study?
Are you NOT pregnant and don't have certain other heart conditions (like a mechanical heart valve)?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to either receive the left atrial appendage closure procedure or to continue with the best standard medical care for your condition. This means you won't get to choose which treatment you receive. You will have regular check-ups and tests throughout the study to monitor your health and see how well the treatment is working. The study will carefully follow your health over time to compare the results between the two groups. The total duration of participation in the study for each person is not specified here, but would involve ongoing follow-up.

Potential risks and benefits

Taking part in any medical study has possible benefits and risks. Potential benefits of this study could include a reduced risk of stroke, especially if the LAA closure procedure is found to be more effective than current treatments for people with your specific health conditions. However, the LAA closure procedure carries some risks, like risks associated with any medical procedure (e.g., bleeding, infection, or complications during the procedure). The standard medical care group might also experience side effects from medications. You will be told about all known risks before you decide to join, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Universität zu Lübeck
Verified postcode
Lübeck, Germany· Recruiting

Common questions

What is atrial fibrillation (AF)?

Atrial fibrillation is a common type of irregular and often very fast heartbeat. It can increase your risk of stroke.

What is end-stage kidney disease?

This is a very advanced stage of kidney failure where your kidneys are no longer able to filter waste products from your blood on their own. People with this condition often need dialysis or a kidney transplant.

What is the Left Atrial Appendage (LAA)?

It's a small, ear-shaped pouch attached to the upper left chamber of your heart. In people with AF, blood can collect there and form clots, which can then cause a stroke.

What is LAA closure?

It's a procedure where a small device is put into the LAA to seal it off. This acts as a barrier to stop blood clots from forming or leaving the LAA.

Will I get to choose my treatment?

No, if you join this study, you will be randomly assigned to either receive the LAA closure procedure or standard medical care. This is a common way to ensure study results are fair and unbiased.

How to find out more

Ingo Eitel, MD

ingo.eitel@uksh.de +49 451 500 44501 Official trial record

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