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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
  Purpose

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?

Condition Intervention Phase
Atrial Fibrillation
Stroke
Procedure: Surgical occlusion of the left atrial appendage
Procedure: Best medical practice
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase III Pilot Study - Left Atrial Appendage Occlusion Study

Resource links provided by NLM:


Further study details as provided by Population Health Research Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 51
Study Start Date: August 2009
Study Completion Date: November 2012
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Occlusion arm
Surgical intervention: Occlusion of the left atrial appendage (LAA) using 'cut-and-sew' technique appendage occlusion.
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
Active Comparator: Medical arm
Medical arm: The comparator is best medical practice for atrial fibrillation related stroke prevention as per guidelines.
Procedure: Best medical practice
Best medical practice for atrial fibrillation related stroke prevention as per guidelines.

Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908700

Locations
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Population Health Research Institute
McMaster University
Sunnybrook Health Sciences Centre
London Health Sciences Centre
Université de Montréal
Investigators
Principal Investigator: Richard Whitlock, MD, FRCSC McMaster University
  More Information

No publications provided

Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT00908700     History of Changes
Other Study ID Numbers: LAAOSII
Study First Received: May 26, 2009
Last Updated: May 13, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Population Health Research Institute:
Atrial fibrillation
Stroke
left atrial appendage
Re-exploration for bleeding

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

ClinicalTrials.gov processed this record on November 19, 2014