Atrial fibrillation (AF) is a common heart rhythm disorder that leads to one-sixth of all strokes. Prevention of strokes in AF is achieved through the use of blood thinners such as coumadin. Although these blood thinners are effective, they are limited by the risk of serious bleeding, by physician and patient reluctance to use, and by noncompliance and discontinuation. The left atrial appendage is a structure on the upper chamber of the heart that is the most common source of stroke in patients with AF. This structure is easily accessible during open heart surgery for removal, and has been an area of interest for stroke prevention. However, there is currently no strong evidence that removing it works. The LAAOS III trial will randomly (like the flip of a coin) assign patients with AF undergoing heart surgery for other reasons to have the left atrial appendage removed or not. These patients, other than this small procedure which has been shown to be quite safe, will be treated in the usual manner. The full study of 4700 patients, followed for an average of 4 years, will determine if removing the left atrial appendage can reduce stroke and other complications on top of usual therapy. A positive study will change the way heart surgery is performed on AF patients and results in a large reduction in the number of strokes in a large population. Further, it will promote further research into this approach that could be applied beyond AF patients undergoing heart surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
4,812
Surgeon will occlude the left atrial appendage using a suture and/or a surgical stapler or a regulatory approved atrial appendage closure during the patient's cardiac surgery procedure.
Hamilton General Hospital
Hamilton, Ontario, Canada
Stroke or systemic arterial embolism
First occurrence of ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism
Time frame: Common termination point (median follow-up of 4 years)
All cause stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism
All cause stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism
Time frame: Common termination point (median follow-up of 4 years)
Ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism or death
Ischemic stroke\* or transient ischemic attack with positive neuroimaging or systemic arterial embolism or death
Time frame: Common termination point (median follow-up of 4 years)
Ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism > 30 days after surgery
Ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism \> 30 days after surgery
Time frame: Common termination point (median follow-up of 4 years)
Total mortality
Total mortality
Time frame: Common termination point (median follow-up of 4 years)
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