RecruitingNAINTERVENTIONAL

The Fourth Left Atrial Appendage Occlusion Study

The LAAOS-4 study is investigating if a procedure using a device called WATCHMAN can prevent strokes or blood clots travelling to other parts of the body in people with a heart condition called atrial fibrillation (AF). People with AF have an irregular heartbeat, which can increase their risk of stroke. This study focuses on individuals who are already taking blood-thinning medication (anticoagulants) but still face a high risk of stroke. Researchers want to see if blocking off a small pouch in the heart, called the left atrial appendage, where clots often form, could offer extra protection against these serious events.

At a glance

Status

Recruiting

Phase

Sponsor

Hamilton Health Sciences Corporation

Enrolment target

4,000

Start

30 Nov 2023

Estimated completion

01 Dec 2029

Atrial Fibrillation Stroke, Ischemic Systemic Embolism

What is this study about?

The LAAOS-4 study is exploring new ways to protect people with atrial fibrillation (AF) from having a stroke. AF is a common heart rhythm problem where the upper chambers of the heart beat irregularly. This can lead to blood clots forming, especially in a small pouch off the heart's upper left chamber called the left atrial appendage (LAA). If a clot breaks loose from the LAA, it can travel to the brain and cause a stroke.

Many people with AF take blood-thinning medications, also known as anticoagulants, to reduce their stroke risk. However, some individuals remain at a high risk of stroke despite being on these medications. This study is testing if a procedure to close off the LAA using a special device, called a WATCHMAN device, can add extra protection for these patients. The WATCHMAN device is inserted into the heart through a small tube in a blood vessel, usually in the leg, to seal off the LAA.

The main goal is to find out if blocking off this specific area in the heart can prevent strokes caused by clots, or prevent clots from travelling to other parts of the body, better than just taking blood thinners alone for those at highest risk. This study is important because it could offer a new option for preventing strokes in a group of patients who need additional protection.

Key takeaways

The study explores if a device can prevent strokes in high-risk AF patients.
It's for people with atrial fibrillation who are already on blood thinners.
The WATCHMAN device aims to seal off a pouch in the heart (LAA) where clots form.
Participation involves ongoing medical checks and comparison of treatments.
It could offer a new way to reduce stroke risk for specific patients.

Who may be eligible?

To be considered for this study, you would need to have atrial fibrillation. This includes people whose atrial fibrillation comes and goes, especially if they've had a stroke or blood clot before. You would also need to be considered at a high risk of stroke, as measured by a specific scoring system called CHA2DS2-VASc, with a score of 4 or higher. Importantly, you must have been taking blood-thinning medication regularly for at least three months, with no plans to stop it during the study.

There are also reasons why someone might not be able to join. For example, if you are under 18, currently have a blood clot in your left atrial appendage, or have had this part of your heart closed off in the past, you wouldn't be eligible. Also, if you've had certain other heart procedures or are planning a procedure for your atrial fibrillation within 90 days, you might not be able to take part. Women who could become pregnant would need to agree to use effective birth control throughout the study. Finally, you would need to be expected to live for at least two more years and be able to understand and agree to take part.

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 you have atrial fibrillation, whether it's constant or comes and goes?
Are you considered at a high risk of stroke by your doctor (CHA2DS2-VASc score of 4 or more)?
Have you been taking blood-thinning medication for at least 3 months and plan to continue?
Are you 18 years or older?
Have you NOT had a previous procedure to close off or remove your left atrial appendage?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have regular check-ups to monitor your health and the effectiveness of the treatment. These check-ups will involve various tests and assessments, similar to what you might already have for your heart condition. The study will compare two groups: one group will continue with their usual blood-thinning medication and receive the WATCHMAN device procedure, while the other group will continue with their usual blood-thinning medication without the device. The exact number of hospital visits, duration of follow-up, and specific tests will be explained in detail by the study team, but generally, participants are typically followed long-term to see the effects of the intervention. The study aims to follow participants to see the long-term effects of the treatments.

Potential risks and benefits

Like any medical procedure or research study, there are potential benefits and risks. A potential benefit of taking part could be a reduced risk of stroke or blood clots, especially if the WATCHMAN device proves to be effective for individuals at high risk. However, there are also risks associated with the WATCHMAN procedure itself, such as potential complications during and after the insertion of the device, like bleeding or infection. The study team will fully explain all known risks and potential side effects to you. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (127)

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

Affinity Hospital dba Grandview Medical Center
Verified postcode
Birmingham, United States· Withdrawn
Arrhythmia Research Group
Verified postcode
Jonesboro, United States· Recruiting
Memorial Health Services
Verified postcode
Fountain Valley, United States· Recruiting
Loma Linda University Health
Verified postcode
Loma Linda, United States· Recruiting
Southern California Permanente Medical Group
Verified postcode
Pasadena, United States· Recruiting
Sutter Valley Hospitals dba Sutter Institute for Medical Research
Verified postcode
Sacramento, United States· Recruiting
JFK Medical Center Limited Partnership d/b/a HCA Florida JFK Hospital
Verified postcode
Atlantis, United States· Recruiting
St. Vincent's Health System
Verified postcode
Jacksonville, United States· Recruiting
Largo Medical Center, Inc. d/b/a HCA Florida Largo Medical Center
Verified postcode
Largo, United States· Recruiting
The University of South Florida
Verified postcode
Tampa, United States· Recruiting
Emory University
Verified postcode
Atlanta, United States· Recruiting
St Luke's Regional Medical Center, Ltd
Verified postcode
Boise, United States· Recruiting

Common questions

What is atrial fibrillation?

Atrial fibrillation (AF) is an irregular and often rapid heart rate that can increase your risk of strokes, heart failure and other heart-related complications.

What is the WATCHMAN device?

The WATCHMAN device is a small implant designed to close off a part of your heart called the left atrial appendage, where blood clots can form in people with AF.

Why am I still at risk of stroke if I take blood thinners?

Even with blood thinners, some people with atrial fibrillation remain at a higher risk of stroke. This study is looking for additional ways to protect them.

Is the WATCHMAN device a permanent solution?

Yes, once implanted, the WATCHMAN device is intended to be a permanent implant that seals off the left atrial appendage.

Will I still need to take blood thinners if I get the WATCHMAN device?

Participants in this study will continue to take blood thinners. The study is investigating if the device offers extra protection alongside ongoing medication.

How to find out more

Program Director

laaos-4@phri.ca 905-521-2100 Official trial record

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