Left Atrial Appendage Occlusion Study III (LAAOS III)
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.
Cardiac Surgery With Cardiopulmonary Bypass
Other: Left Atrial Appendage Occlusion
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Left Atrial Appendage Occlusion Study III|
- Stroke or systemic arterial embolism [ Time Frame: Common termination point (median follow-up of 4 years) ] [ Designated as safety issue: No ]First occurrence of total stroke or systemic arterial embolism
- Total mortality [ Time Frame: Common termination point (median follow-up of 4 years) ] [ Designated as safety issue: No ]Total mortality
- Operative safety outcomes [ Time Frame: 30 days post-surgery ] [ Designated as safety issue: Yes ]Operative safety outcomes (30-day mortality, chest tube output in the first post-operative 24 hours, rate of post-operative re-exploration for bleeding)
- Readmission for heart failure [ Time Frame: Common termination point (median follow-up of 4 years) ] [ Designated as safety issue: No ]Readmission for heart failure
- Major bleed [ Time Frame: Common termination point (median follow-up of 4 years) ] [ Designated as safety issue: No ]Major bleed
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||May 2019|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Experimental: Left Atrial Appendage Occlusion Group
Surgeon will close the left atrial appendage using a suture and/or a surgical stapler during the patient's cardiac surgery procedure.
Other: Left Atrial Appendage Occlusion
Surgeon will occlude the left atrial appendage using a suture and/or a surgical stapler during the patient's cardiac surgery procedure.
No Intervention: No Left Atrial Appendage Occlusion Group
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01561651
|Contact: Richard Whitlock, MD||905-527-4322 ext email@example.com|
|Contact: Kate Brady||905-527-4322 ext firstname.lastname@example.org|
|Hamilton General Hospital||Recruiting|
|Hamilton, Ontario, Canada, L8L 2X2|
|Contact: Richard Whitlock, MD 905-527-4322 ext 40305 email@example.com|
|Principal Investigator: Richard Whitlock, MD|
|Principal Investigator:||Richard Whitlock, MD||Population Health Research Institute/McMaster University|
|Study Chair:||Stuart Connolly, MD, PhD||Population Health Research Institute/McMaster University|