Atrial Fibrillation, Cardiac Surgery With Cardiopulmonary Bypass
Conditions
Keywords
cardiac surgery, left atrial appendage, atrial fibrillation, stroke, non-CNS systemic embolism
Brief summary
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.
Interventions
OTHERLeft Atrial Appendage Occlusion
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.
Sponsors
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Greater than 18 years of age 2. Undergoing a clinically indicated cardiac surgical procedure with the use of cardiopulmonary bypass 3. Have a documented history of atrial fibrillation or atrial flutter 4. CHA2DS2-VASc score ≥ 2 5. Have provided informed consent
Exclusion criteria
1. Patients undergoing off-pump cardiac surgery 2. Patients undergoing any of the following procedures: * heart transplant * complex congenital heart surgery * sole indication for surgery is ventricular assist device insertion * previous cardiac surgery requiring opening of the pericardium * mechanical valve implant 3. Patients who have had a previous placement of a percutaneous left atrial appendage closure device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stroke or systemic arterial embolism | Common termination point (median follow-up of 4 years) | First occurrence of ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism | Common termination point (median follow-up of 4 years) | All cause stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism |
| Ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism or death | 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 > 30 days after surgery | 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 |
| Total mortality | Common termination point (median follow-up of 4 years) | Total mortality |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post-operative safety outcomes | 30 days post-surgery | Operative safety outcomes (30-day mortality, chest tube output in the first post-operative 24 hours, rate of post-operative re-exploration for bleeding) |
| Major bleeding | Common termination point (median follow-up of 4 years) | Major bleeding |
| Myocardial infarction | Common termination point (median follow-up of 4 years) | Myocardial infarction |
| Readmission for heart failure | Common termination point (median follow-up of 4 years) | Readmission for heart failure |
Countries
Canada
Outcome results
None listed