Left Atrial Appendage Occlusion Study III (LAAOS III)

This study is currently recruiting participants.
Verified April 2013 by McMaster University
Sponsor:
Information provided by (Responsible Party):
Richard Whitlock, McMaster University
ClinicalTrials.gov Identifier:
NCT01561651
First received: March 20, 2012
Last updated: April 19, 2013
Last verified: April 2013

March 20, 2012
April 19, 2013
July 2012
May 2016   (final data collection date for primary outcome measure)
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
Stroke or non-CNS systemic embolism [ Time Frame: Common termination point (median follow-up of 4 years) ] [ Designated as safety issue: No ]
First occurrence of total stroke or non-CNS systemic embolism
Complete list of historical versions of study NCT01561651 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Left Atrial Appendage Occlusion Study III
Left Atrial Appendage Occlusion Study 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Cardiac Surgery With Cardiopulmonary Bypass
  • Atrial Fibrillation
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.
  • 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.
    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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4700
May 2019
May 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Greater than 18 years of age
  2. Undergoing a clinically indicated cardiac surgical procedure
  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
    • ventricular assist device insertion
    • re-operation
    • mechanical valve implant
  3. Patients who have had a previous placement of a percutaneous left atrial appendage closure device
Both
18 Years and older
No
Contact: Richard Whitlock, MD 905-527-4300 ext 40305 richard.whitlock@phri.ca
Contact: Jessica Vincent 905-527-4300 ext 40635 jessica.vincent@phri.ca
Canada
 
NCT01561651
LAAOSIII-2012
Yes
Richard Whitlock, McMaster University
Population Health Research Institute
Not Provided
Principal Investigator: Richard Whitlock, MD Population Health Research Institute/McMaster University
Study Chair: Stuart Connolly, MD, PhD Population Health Research Institute/McMaster University
McMaster University
April 2013

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