Left Atrial Appendage Occlusion Study III (LAAOS III)

Tracking Information
First Submitted Date ICMJE	March 20, 2012
First Posted Date ICMJE	March 23, 2012
Last Update Posted Date	September 9, 2016
Study Start Date ICMJE	July 2012
Estimated Primary Completion Date	November 2020 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 24, 2015)	Stroke or systemic arterial embolism [ Time Frame: 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
Original Primary Outcome Measures ICMJE; (submitted: March 21, 2012)	Stroke or non-CNS systemic embolism [ Time Frame: Common termination point (median follow-up of 4 years) ]; First occurrence of total stroke or non-CNS systemic embolism
Change History	Complete list of historical versions of study NCT01561651 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 24, 2015)	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) ]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 [ 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 > 30 days after surgery [ 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; Total mortality [ Time Frame: Common termination point (median follow-up of 4 years) ]Total mortality
Original Secondary Outcome Measures ICMJE; (submitted: March 21, 2012)	Total mortality [ Time Frame: Common termination point (median follow-up of 4 years) ]Total mortality; Operative safety outcomes [ Time Frame: 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); Readmission for heart failure [ Time Frame: Common termination point (median follow-up of 4 years) ]Readmission for heart failure; Major bleed [ Time Frame: Common termination point (median follow-up of 4 years) ]Major bleed
Current Other Outcome Measures ICMJE; (submitted: August 24, 2015)	Readmission for heart failure [ Time Frame: Common termination point (median follow-up of 4 years) ]Readmission for heart failure; Post-operative safety outcomes [ Time Frame: 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 [ Time Frame: Common termination point (median follow-up of 4 years) ]Major bleeding; Myocardial infarction [ Time Frame: Common termination point (median follow-up of 4 years) ]Myocardial infarction
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Left Atrial Appendage Occlusion Study III
Official Title ICMJE	Left Atrial Appendage Occlusion Study III
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition ICMJE	Cardiac Surgery With Cardiopulmonary Bypass; Atrial Fibrillation
Intervention ICMJE	Other: Left 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.
Study Arms	Experimental: Left Atrial Appendage Occlusion Group 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. Intervention: Other: Left Atrial Appendage Occlusion; 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.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: October 5, 2012)	4700
Original Estimated Enrollment ICMJE; (submitted: March 21, 2012)	3500
Estimated Study Completion Date	November 2020
Estimated Primary Completion Date	November 2020 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Greater than 18 years of age; Undergoing a clinically indicated cardiac surgical procedure with the use of cardiopulmonary bypass; Have a documented history of atrial fibrillation or atrial flutter; CHA2DS2-VASc score ≥ 2; Have provided informed consent Exclusion Criteria: Patients undergoing off-pump cardiac surgery; 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; Patients who have had a previous placement of a percutaneous left atrial appendage closure device
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Richard Whitlock, MD 905-527-4322 ext 40305 richard.whitlock@phri.ca Contact: Kate Brady 905-527-4322 ext 41198 kate.brady@phri.ca
Listed Location Countries ICMJE	Canada
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01561651
Other Study ID Numbers ICMJE	LAAOSIII-2012
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Richard Whitlock, McMaster University
Study Sponsor ICMJE	Population Health Research Institute
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Richard Whitlock, MD Population Health Research Institute/McMaster University Study Chair: Stuart Connolly, MD, PhD Population Health Research Institute/McMaster University
PRS Account	McMaster University
Verification Date	September 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP