Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
This study aims to discover if a combination of an operation to close off the left atrial appendage (LAAO) and blood-thinning medication (DOACs) is more effective at preventing further strokes than blood-thinning medication alone. This is for people in the UK who have a heart condition called atrial fibrillation (AF) and have experienced a stroke, even though they were already taking blood-thinning medication. Atrial fibrillation can cause blood clots to form in the LAA, leading to strokes. Doctors want to find the best way to stop these recurring strokes, as the current standard treatment doesn't always prevent them. This research hopes to improve how we protect these patients from future strokes.
At a glance
What is this study about?
This study is about a heart condition called atrial fibrillation (AF), which causes an irregular heartbeat. One of the main concerns with AF is that it can lead to strokes. To reduce this risk, people with AF are usually prescribed blood-thinning medicines, called Direct Oral Anticoagulants (DOACs). However, some people still have a stroke even when they are taking these medications. This study is looking for a better way to protect these individuals from having another stroke.
Researchers are investigating whether a procedure to close off a small pouch in the heart, called the left atrial appendage (LAA), could offer extra protection. This pouch is often where blood clots form in people with AF, and these clots can travel to the brain and cause a stroke. The idea is that if the LAA is closed, it might reduce the risk of clots forming there, even if someone is already on blood-thinning medication.
This study will compare two approaches: one group will receive the standard blood-thinning medication, and the other group will receive the blood-thinning medication plus the LAA closure procedure. By doing this, the researchers hope to find out if combining the procedure with medication is more effective at preventing another stroke, serious blood clots elsewhere in the body, or death from heart-related causes, compared to just taking the medication alone. Ultimately, this research aims to improve future care for patients with AF who have had a stroke despite their current treatment.
Key takeaways
- Targets people with Atrial Fibrillation (AF) who had a stroke despite blood thinners.
- Compares standard blood thinners (DOACs) to DOACs plus a procedure called LAA closure.
- Aims to see if LAA closure offers additional protection against future strokes.
- Participation involves regular follow-up visits for up to 4 years.
- Potential benefits include reduced stroke risk; risks relate to the procedure and medication.
- No cost to participate, and you can withdraw at any time.
Who may be eligible?
To join this study, participants need to be at least 18 years old and have a heart rhythm problem called atrial fibrillation. They must also have recently (within the last three months) experienced a stroke even though they were already taking blood-thinning medication to prevent strokes. It's important that they are able to continue taking blood-thinning medication long-term.
There are also some reasons why someone might not be able to join. For example, if they have other medical conditions that caused their stroke (like a narrowing of a major artery to the brain), or if they have certain serious heart valve problems. People who have had specific heart procedures in the past, or who have very severe kidney or heart muscle problems, would also not be able to participate. Additionally, if you have a known allergy or intolerance to the blood-thinning medication, you wouldn't be able to join.
The research team will carry out several checks to ensure that joining this study is safe and appropriate for each potential participant.
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?
- Have you been diagnosed with Atrial Fibrillation?
- Have you had a stroke within the last 3 months, even while taking blood thinners?
- Are you able to take blood-thinning medication long-term?
- Do you have any serious heart valve problems?
- Have you had other specific conditions that caused your stroke (e.g., major artery narrowing)?
What does participation involve?
If you join this study, you will first be randomly assigned to one of two groups: one group will continue with your blood-thinning medication (DOAC) as usual, and the other group will also receive the LAA closure procedure in addition to your DOAC. The procedure involves a doctor inserting a small device to close off the left atrial appendage.
Both groups will be closely monitored. You will have regular follow-up visits, starting at 6 months after joining the study and then every 6 months until the study ends. The total time you could be followed in the study is up to four years. During these visits, doctors will check your general health, how you are responding to treatment, and look for any potential side effects or further health events.
Potential risks and benefits
Locations (28)
- AZ Sint Jan BruggeVerified postcodeBruges, Belgium· Recruiting
- Brussels University HospitalVerified postcodeBrussels, Belgium· Recruiting
- UCLouvain - Cliniques universitaires Saint-LucVerified postcodeBrussels, Belgium· Recruiting
- HUmani CHU Charleroi-ChimayVerified postcodeCharleroi, Belgium· Recruiting
- Universitair Ziekenhuis (UZ) LeuvenVerified postcodeLeuven, Belgium· Recruiting
- UKSH, Campus LübeckVerified postcodeLübeck, Germany· Recruiting
- Charité-Universitätsmedizin BerlinVerified postcodeBerlin, Germany· Recruiting
- Universitätsklinikum BonnVerified postcodeBonn, Germany· Recruiting
- Universitätsmedizin GöttingenVerified postcodeGöttingen, Germany· Recruiting
- Asklepios Klinik AltonaVerified postcodeHamburg, Germany· Recruiting
- University Hospital HeidelbergVerified postcodeHeidelberg, Germany· Recruiting
- Universitätsklinikum LeipzigVerified postcodeLeipzig, Germany· Recruiting
Common questions
What is Atrial Fibrillation?
Atrial fibrillation (AF) is a common heart condition that causes an irregular and often abnormally fast heart rate.
What is a Left Atrial Appendage (LAA)?
It's a small, ear-shaped pouch attached to the upper left chamber of your heart where blood clots can form in people with atrial fibrillation.
What are DOACs?
DOACs are Direct Oral Anticoagulants, which are blood-thinning medications used to prevent blood clots and reduce stroke risk in people with atrial fibrillation.
Why is this study important?
This study aims to find a better way to prevent strokes in people with atrial fibrillation who have already had a stroke despite taking standard blood-thinning medication.
Will I have to pay to participate?
No, all study-related treatments and assessments are provided free of charge if you meet the eligibility criteria.
How to find out more
Lorenz Räber, Prof., MD, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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