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
  Purpose

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 Intervention
Cardiac Surgery With Cardiopulmonary Bypass
Atrial Fibrillation
Other: Left Atrial Appendage Occlusion

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 4700
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)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01561651

Contacts
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

Locations
Canada, Ontario
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Richard Whitlock, MD    905-527-4322 ext 40305    richard.whitlock@phri.ca   
Principal Investigator: Richard Whitlock, MD         
Sponsors and Collaborators
Population Health Research Institute
Investigators
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

No publications provided

Responsible Party: Richard Whitlock, Assistant Professor, McMaster University
ClinicalTrials.gov Identifier: NCT01561651     History of Changes
Other Study ID Numbers: LAAOSIII-2012
Study First Received: March 20, 2012
Last Updated: April 19, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
cardiac surgery
left atrial appendage
atrial fibrillation
stroke
non-CNS systemic embolism

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 21, 2014