An interventional study of Left Atrial Appendage Occlusion in Cardiac Surgery With Cardiopulmonary Bypass and Atrial Fibrillation, sponsored by Population Health Research Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-13.
Sponsored by Population Health Research Institute · Not applicable, Interventional, and Prevention
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.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's enrollment of 4,812 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Population Health Research Institute is the lead sponsor of 115 studies on the registry; 26 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients undergoing any of the following procedures:
Surgeon will close the left atrial appendage using a suture and/or a surgical stapler or a regulatory approved atrial appendage closure device during the patient's cardiac surgery procedure.
Other: Left Atrial Appendage Occlusion
Surgeon will not close the left atrial appendage during the patient's cardiac surgery procedure. Patient will be treated as per best medical practice for stroke prevention in atrial fibrillation. Treatment will be decided by the patient's primary care physician.
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.
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)
Readmission for heart failure
Readmission for heart failure
Time frame: Common termination point (median follow-up of 4 years)
Post-operative safety outcomes
Operative safety outcomes (30-day mortality, chest tube output in the first post-operative 24 hours, rate of post-operative re-exploration for bleeding)
Time frame: 30 days post-surgery
Major bleeding
Major bleeding
Time frame: Common termination point (median follow-up of 4 years)
Myocardial infarction
Myocardial infarction
Time frame: Common termination point (median follow-up of 4 years)
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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