The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Completed
First Posted : March 23, 2012
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
Richard Whitlock, McMaster University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Cardiac Surgery With Cardiopulmonary Bypass Atrial Fibrillation Other: Left Atrial Appendage Occlusion Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4812 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Left Atrial Appendage Occlusion Study III
Actual Study Start Date : July 2012
Actual Primary Completion Date : April 2021
Actual Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 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.
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Total mortality [ Time Frame: Common termination point (median follow-up of 4 years) ]
    Total mortality


Other Outcome Measures:
  1. Readmission for heart failure [ Time Frame: Common termination point (median follow-up of 4 years) ]
    Readmission for heart failure

  2. 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)

  3. Major bleeding [ Time Frame: Common termination point (median follow-up of 4 years) ]
    Major bleeding

  4. Myocardial infarction [ Time Frame: Common termination point (median follow-up of 4 years) ]
    Myocardial infarction


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561651


Locations
Layout table for location information
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Population Health Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Richard Whitlock, MD Population Health Research Institute/McMaster University
Study Chair: Stuart Connolly, MD, PhD Population Health Research Institute/McMaster University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Richard Whitlock, Assistant Professor, McMaster University
ClinicalTrials.gov Identifier: NCT01561651    
Other Study ID Numbers: LAAOSIII-2012
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: January 2022
Keywords provided by Richard Whitlock, McMaster University:
cardiac surgery
left atrial appendage
atrial fibrillation
stroke
non-CNS systemic embolism
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes