Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
This study aims to find out if a procedure to close off a small pouch in the heart, called the left atrial appendage (LAA), can stop strokes or blood clot problems in other parts of the body. They are testing this in people who are already having open-heart surgery and have a higher chance of developing these issues. The researchers are comparing this new approach, using a device called AtriClip, against the usual care to see if it makes a noticeable difference. It's an important study to help improve how we prevent strokes in vulnerable patients.
At a glance
What is this study about?
This research study is trying to find a better way to prevent a type of stroke called an ischemic stroke, or blood clots travelling to other parts of the body, which doctors call systemic embolism. These happen when a blood clot blocks an artery.
The study focuses on a small pouch in the heart called the left atrial appendage (LAA). For some people, especially those at risk of an irregular heartbeat called atrial fibrillation, blood clots can form in this pouch. If these clots break off, they can travel to the brain and cause a stroke.
Researchers want to see if closing off this LAA during open-heart surgery, using a special device called the AtriClip, can reduce the risk of these harmful blood clots. They will compare patients who have the LAA closed with those who just receive standard heart surgery without this additional step, to see if the AtriClip makes a real difference in preventing strokes.
Key takeaways
- This study evaluates preventing stroke by closing a heart pouch (LAA).
- It's for people having heart surgery and at higher stroke risk.
- A device called AtriClip is used to close the LAA.
- It's a 'blinded' study, meaning you won't know if you received the LAA closure.
- Participation involves your planned heart surgery and follow-up checks.
Who may be eligible?
To join this study, you need to be at least 18 years old and be having heart surgery soon. You also need to have certain risk factors that suggest you are at a higher chance of having a stroke, for example, based on your age and other heart health indicators.
However, you cannot join if you have already been diagnosed with atrial fibrillation or a similar irregular heartbeat that has lasted for longer than 6 minutes. You also can't be part of the study if you've already had a similar procedure on your LAA, have certain other serious health conditions like active infections, or are pregnant. If your doctor believes you wouldn't be able to keep up with the study's appointments, you would also not be able to participate.
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?
- Are you scheduled for open-heart surgery soon?
- Do you have certain risk factors for stroke that your doctor identifies?
- Have you *not* had a long, lasting irregular heartbeat (like atrial fibrillation) previously?
- Have you *not* had a similar LAA procedure done before?
- Are you able to attend follow-up appointments after your surgery?
What does participation involve?
If you choose to take part in this study, you will be randomly assigned to either receive the LAA closure during your planned heart surgery or to have your heart surgery as normal. Neither you nor your doctors will know which group you are in. You will have regular check-ups and assessments during and after your surgery, similar to what's typical for heart surgery recovery, but also some specific to the study. The total duration of your participation will involve follow-up visits over a period of time to track your health and any events like strokes.
Potential risks and benefits
Locations (138)
- Heart Center Research / Huntsville HospitalVerified postcodeHuntsville, United States
- HonorHealth Shea Scottsdale HealthcareVerified postcodeScottsdale, United States
- St. Bernard's Heart & VascularVerified postcodeJonesboro, United States
- CHI St. VincentVerified postcodeLittle Rock, United States
- Arkansas Heart HospitalVerified postcodeLittle Rock, United States
- Memorial Care Long Beach Medical CenterVerified postcodeLong Beach, United States
- Keck Medical Center of USCVerified postcodeLos Angeles, United States
- Hoag Memorial Hospital PresbyterianVerified postcodeNewport Beach, United States
- Sutter Sacramento HospitalVerified postcodeSacramento, United States
- Stanford UniversityVerified postcodeStanford, United States
- University of ColoradoVerified postcodeBoulder, United States
- Hartford HospitalVerified postcodeHartford, United States
Common questions
What is the Left Atrial Appendage (LAA)?
It's a small, ear-shaped pouch attached to the upper left chamber of your heart. In some people, blood clots can form here.
Why is this study 'blinded'?
Being 'blinded' means neither you nor your care team will know if you received the LAA closure or not. This helps ensure the study results are fair and unbiased.
What is the AtriClip?
The AtriClip is a small device designed to permanently close off the left atrial appendage during heart surgery.
Will I still need to take blood thinners if I have the LAA closed?
This study aims to understand the best approach. Your doctor will discuss all your medication needs, including blood thinners, based on your individual health.
Can I leave the study at any time?
Yes, your participation is voluntary, and you can withdraw from the study at any point without impacting your medical treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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