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Sponsors and Collaborators: |
Lawson Health Research Institute Medtronic |
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Information provided by: | Lawson Health Research Institute |
ClinicalTrials.gov Identifier: | NCT00338715 |
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. AF is associated with a two-fold increase in patient complications and mortality after heart surgery. During AF, the heart muscle does not contract properly causing the blood flow through the heart to slow down potentially forming clots. A clot may then enter the blood stream and be carried to the brain, possibly causing a stroke. Patients in persistent AF require blood thinners to prevent strokes, and this carries its own bleeding risks especially in elderly patients. Patients in AF after heart surgery spend twice as many days in the intensive care unit and 3 to 4 more days in the hospital, hence the impact on hospital resources is quite significant. Various medications are used to prevent AF after heart surgery but they are unable to completely prevent this complication and the medications have associated side effects. In an effort to optimize the care of heart surgery patients, strategies set on eliminating the onset of AF after surgery, as opposed to trying to control AF with less than effective medications, is a necessity. We are proposing a study to determine if isolating the misfiring areas that cause AF at the time of bypass surgery in high-risk patients will decrease the occurrence of AF following heart surgery. Consenting patients will be randomized to one of two groups. Group 1 will undergo bypass surgery plus the additional procedure of pulmonary vein isolation and Group 2 will undergo bypass surgery only, without the additional procedure. Four staff cardiac surgeons at the London Health Sciences Centre will perform all surgeries. Patients will be seen postoperatively every six months and will be followed for a two-year period. The occurrence of AF will be recorded as well as other complications and lengths of hospital stay. We predict that the group with the additional pulmonary vein isolation procedure to prevent AF will have a much lower occurrence of this complication. If this is found to be beneficial, this will significantly decrease the complications and mortality associated with heart surgery. This will have a profound effect in the delivery of care to patients with coronary artery disease and other forms of heart disease.
Condition | Intervention | Phase |
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Atrial Fibrillation |
Device: PVI with Medtronic's Cardioblate BP2 radiofrequency catheter |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Controlled Trial of Prophylactic Pulmonary Vein Isolation as Adjunct to Coronary Artery Bypass Grafting |
Estimated Enrollment: | 158 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Prophylactic Pulmonary Vein Isolation in Addition to CABG for the prevention of postoperative Atrial Fibrillation
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Device: PVI with Medtronic's Cardioblate BP2 radiofrequency catheter
Ablation of the right and left pulmonary veins
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Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stephanie A Fox, BA, RRT | 519-685-8500 ext 35031 | Stephanie.Fox@lhsc.on.ca |
Contact: Bob Kiaii, MD | 519-685-8500 ext 33153 | Bob.Kiaii@lhsc.on.ca |
Canada, Ontario | |
London Health Sciences Centre, University Hospital | Recruiting |
London, Ontario, Canada, N6A 5A5 | |
Principal Investigator: Bob Kiaii, MD, FRCSC | |
Sub-Investigator: Richard J Novick, MD, FRCSC | |
Sub-Investigator: Ray L Guo, MD, FRCSC | |
Sub-Investigator: Mackenzie A Quantz, MD, FRCSC | |
Sub-Investigator: Allan Skanes, MD, FRCPC | |
Sub-Investigator: Pavan K Koka, BSc, MD |
Principal Investigator: | Bob Kiaii, MD, FRCSC | Department of Cardiac Surgery, University of Western Ontario and the London Health Sciences Centre |
Responsible Party: | London Health Sciences Centre, University Hospital ( Dr. Bob Kiaii ) |
Study ID Numbers: | R-06-035, 11973 |
Study First Received: | June 19, 2006 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00338715 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Effectiveness Pulmonary Vein Isolation Procedure Coronary Artery Bypass Surgery Atrial Fibrillation |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Heart Diseases Cardiovascular Diseases Atrial Fibrillation Arrhythmias, Cardiac |