Status:
COMPLETED
Left Atrial Appendage Occlusion Study II
Lead Sponsor:
Population Health Research Institute
Collaborating Sponsors:
McMaster University
Sunnybrook Health Sciences Centre
Conditions:
Atrial Fibrillation
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 wit...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00908700
Start Date
August 1 2009
End Date
November 1 2012
Last Update
September 23 2015
Active Locations (1)
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1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2