Status:
COMPLETED
Effectiveness of Pulmonary Vein Isolation in Prevention of Atrial Fibrillation Following Heart Bypass Surgery
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Medtronic
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
Atrial fibrillation (AF) is an irregular heart rhythm that occurs in 30% to 40% of patients following heart surgery. This irregular heart rhythm, although often self-limiting, can be cause for concern...
Detailed Description
Atrial fibrillation (AF) is a well recognized postoperative complication associated with cardiac surgery occurring in approximately 30% to 40% of patients. AF occurs most frequently within 24 to 72 ho...
Eligibility Criteria
Inclusion
- Adult patients (Age\>=18) undergoing elective coronary artery bypass grafting with cardiopulmonary bypass by 4 surgeons at the London Health Sciences Centre
- Patients at high risk of developing postoperative atrial fibrillation--patients are required to meet one or more of the following criteria:
- Age \>=65
- Ejection Fraction \<50% or Left Ventricle Grade of 2-3
- Diabetes Mellitus (independent of type of management)
Exclusion
- Any documented prior history of atrial fibrillation (paroxysmal/chronic)
- Contraindication to Beta Blockers
- Severe COPD with intolerance to Beta Blockers
- Concomitant non-CABG procedure
- Enrollment in another RCT
- Inability to obtain informed consent
- Patients' inability to attend follow-up visits
- Grade IV left ventricle (EF \<20%)
- Redo CABG procedure
- Off-pump coronary artery bypass surgery
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
193 Patients enrolled
Trial Details
Trial ID
NCT00338715
Start Date
July 1 2006
End Date
September 1 2010
Last Update
February 8 2011
Active Locations (1)
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1
London Health Sciences Centre, University Hospital
London, Ontario, Canada, N6A 5A5