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Trial record 1 of 1 for:    LAAOS III
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Left Atrial Appendage Occlusion Study III (LAAOS III)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01561651
Recruitment Status : Active, not recruiting
First Posted : March 23, 2012
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Richard Whitlock, McMaster University

Tracking Information
First Submitted Date  ICMJE March 20, 2012
First Posted Date  ICMJE March 23, 2012
Last Update Posted Date December 3, 2018
Study Start Date  ICMJE July 2012
Estimated Primary Completion Date November 2022   (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
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 Pre-specified Outcome Measures
 (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 Pre-specified Outcome Measures 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  ICMJE 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  ICMJE
  • 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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 30, 2018)
4812
Original Estimated Enrollment  ICMJE
 (submitted: March 21, 2012)
3500
Estimated Study Completion Date  ICMJE November 2022
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
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  ICMJE 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 November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP