Effectiveness of Pulmonary Vein Isolation in Prevention of Atrial Fibrillation Following Heart Bypass Surgery

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00338715
First received: June 19, 2006
Last updated: February 7, 2011
Last verified: February 2011
  Purpose

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
Atrial Fibrillation
Device: PVI with Medtronic's Cardioblate BP2 radiofrequency catheter
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Prophylactic Pulmonary Vein Isolation as Adjunct to Coronary Artery Bypass Grafting

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Composite endpoint of perioperative death +/- one of 10 major complications. [ Time Frame: while in hospital and within 30 days of discharge from hospital ] [ Designated as safety issue: No ]

Enrollment: 193
Study Start Date: July 2006
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  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: NCT00338715

Locations
Canada, Ontario
London Health Sciences Centre, University Hospital
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
Medtronic
Investigators
Principal Investigator: Bob Kiaii, MD, FRCSC Department of Cardiac Surgery, University of Western Ontario and the London Health Sciences Centre
  More Information

Publications:

Responsible Party: Dr. Bob Kiaii, London Health Sciences Centre, University Hospital
ClinicalTrials.gov Identifier: NCT00338715     History of Changes
Other Study ID Numbers: R-06-035, 11973
Study First Received: June 19, 2006
Last Updated: February 7, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Effectiveness
Pulmonary Vein Isolation Procedure
Coronary Artery Bypass Surgery
Atrial Fibrillation

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

ClinicalTrials.gov processed this record on September 18, 2014