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Left Atrial Appendage Occlusion Study II (LAAOSII)

This study has been completed.
Sponsor:
Collaborators:
McMaster University
Sunnybrook Health Sciences Centre
London Health Sciences Centre
Université de Montréal
Information provided by (Responsible Party):
Population Health Research Institute
ClinicalTrials.gov Identifier:
NCT00908700
First received: May 26, 2009
Last updated: May 13, 2013
Last verified: May 2013
History of Changes

May 26, 2009
May 13, 2013
August 2009
November 2010   (final data collection date for primary outcome measure)
Demonstration of efficacy of cut-and-sew and stapler technique of appendage occlusion by intraoperative transesophageal echocardiography, central adjudication. [ Time Frame: Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00908700 on ClinicalTrials.gov Archive Site
Demonstration of study feasibility, procedure safety, including rate of post-operative re-exploration for bleeding. [ Time Frame: Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Left Atrial Appendage Occlusion Study II
Phase III Pilot Study - Left Atrial Appendage Occlusion Study

A pilot, multicentre randomized controlled study of surgical left atrial occlusion (LAA) in 50 patients with atrial fibrillation/flutter undergoing cardiac surgery requiring cardiopulmonary bypass with additional risk factors for late stroke.

Patients will be enrolled and randomized to undergo LAA exclusion and aspirin therapy or best medical therapy as per guidelines.

Main research questions:

  1. Can successful occlusion of the LAA be safely achieved by cut and sew or stapler techniques?
  2. In patients with atrial fibrillation with 2 or more risk factors for stroke, will removal of the left atrial appendage (LAA) and aspirin therapy reduce the risk of systemic embolic events and major bleeding compared to warfarin?

The number one cause of disability and the 3rd leading cause of death in patients with atrial fibrillation (AF) is stroke. Echocardiographic studies suggest that the predominant source of stroke in AF is the left atrial appendage (LAA). At present, there are no sufficiently powered trials to answer whether removal of the LAA can reduce the risk of systemic embolic events.

LAAOS pilot study will recruit 50 participants undergoing open-heart surgery in 5 Canadian academic cardiac surgery centers. The study will inform the feasibility of conducting a large RCT and will provide information of the efficacy and safety of appendage occlusion technique. From this study we envision a a large international randomized controlled trial (LAAOS II) to determine the impact of left atrial appendage occlusion on the composite outcome of stroke and non-central nervous system systemic embolic events in at risk patients with atrial fibrillation undergoing cardiac surgery.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Atrial Fibrillation
  • Stroke
  • Procedure: Surgical occlusion of the left atrial appendage
    Study intervention: Within the trial, occlusion must be performed using either amputation and closure (cut and sew) or stapler device.
    Other Name: Surgical occlusion of the left atrial appendage
  • Procedure: Best medical practice
    Best medical practice for atrial fibrillation related stroke prevention as per guidelines.
  • Experimental: Occlusion arm
    Surgical intervention: Occlusion of the left atrial appendage (LAA) using 'cut-and-sew' technique appendage occlusion.
    Intervention: Procedure: Surgical occlusion of the left atrial appendage
  • Active Comparator: Medical arm
    Medical arm: The comparator is best medical practice for atrial fibrillation related stroke prevention as per guidelines.
    Intervention: Procedure: Best medical practice
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
November 2012
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients undergoing any cardiac surgical procedure with the use of cardiopulmonary bypass

  • A history of ECG-documented atrial fibrillation with prior stroke or TIA, or at least two of the following risk factors:

    • age => 65 years
    • hypertension
    • diabetes mellitus, or
    • heart failure/left ventricular ejection fraction < 50%

Exclusion Criteria:

  • Patients in whom surgical AF ablation (MAZE or otherwise) is planned
  • Planned "off-pump" surgery
  • Planned implantation of a mechanical valve
  • Heart transplant, complex congenital heart surgery, and ventricular assist device insertion, reoperation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00908700
LAAOSII
No
Population Health Research Institute
Population Health Research Institute
  • McMaster University
  • Sunnybrook Health Sciences Centre
  • London Health Sciences Centre
  • Université de Montréal
Principal Investigator: Richard Whitlock, MD, FRCSC McMaster University
Population Health Research Institute
May 2013

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