Effectiveness of Pulmonary Vein Isolation in Prevention of Atrial Fibrillation Following Heart Bypass Surgery
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|ClinicalTrials.gov Identifier: NCT00338715|
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : February 8, 2011
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 or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Device: PVI with Medtronic's Cardioblate BP2 radiofrequency catheter||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||193 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial of Prophylactic Pulmonary Vein Isolation as Adjunct to Coronary Artery Bypass Grafting|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||September 2010|
Prophylactic Pulmonary Vein Isolation in Addition to CABG for the prevention of postoperative Atrial Fibrillation
Device: PVI with Medtronic's Cardioblate BP2 radiofrequency catheter
Ablation of the right and left pulmonary veins
Other Name: Medtronic's Cardioblate BP2 radiofrequency catheter
- Incidence of postoperative atrial fibrillation as documented on telemetry/ECG for >=30 minutes while in hospital or AF requiring immediate intervention ie.cardioversion [ Time Frame: while in hospital ]
- Composite endpoint of perioperative death +/- one of 10 major complications. [ Time Frame: while in hospital and within 30 days of discharge from hospital ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00338715
|London Health Sciences Centre, University Hospital|
|London, Ontario, Canada, N6A 5A5|
|Principal Investigator:||Bob Kiaii, MD, FRCSC||Department of Cardiac Surgery, University of Western Ontario and the London Health Sciences Centre|