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Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation

This study has been completed.
Information provided by (Responsible Party):
Lawrence Wei, University of Pittsburgh Identifier:
First received: September 30, 2008
Last updated: February 11, 2016
Last verified: February 2016

Atrial Fibrillation (AF) is one of the most common postoperative complications after coronary artery bypass grafting (CABG). Postoperative AF produces a substantial impact on hospital resources with an estimated annual expenditure of over $1 billion. This includes the cost of pharmacological treatment and the cost of the increased length of stay. The incidence of AF is about 30-40% in CABG patients and increases with age of the patient. As the average age of the patient that undergoes CABG surgery is increasing, it is critical to find a way to prevent or reduce the incidence of this complication.

We propose a prospective, randomized, controlled study to determine the role of pulmonary vein isolation by bipolar ablation in the prevention or reduction of postoperative AF. The block- randomization plan will be used to maintain balance of the study and control arms throughout the study.

Condition Intervention Phase
Postoperative Atrial Fibrillation
Procedure: Isolation of pulmonary veins with Bipolar radiofrequency ablation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Reduced incidence of Postoperative Atrial fibrillation [ Time Frame: 12 hours ]

Enrollment: 35
Study Start Date: December 2005
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pulmonary Vein isolation
Patients in this arm will receive pulmonary vein isolation during surgery
Procedure: Isolation of pulmonary veins with Bipolar radiofrequency ablation
No Intervention: Standard of care
Subjects in this arm will receive standard of care and no pulmonary vein isolation


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients who require an isolated elective CABG surgery on CPB.
  2. Both male and female patients of age 18 years to 90 years.

Exclusion Criteria:

  1. Pre existing atrial fibrillation or history of previous atrial fibrillation.
  2. Inability to provide informed consent.
  3. Pregnant or nursing patients.
  4. Reoperative sternotomy
  5. Emergency CABG surgery.
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Please refer to this study by its identifier: NCT00765089

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15102
Sponsors and Collaborators
University of Pittsburgh
  More Information

Responsible Party: Lawrence Wei, Associate Professor, University of Pittsburgh Identifier: NCT00765089     History of Changes
Other Study ID Numbers: 0508144
Study First Received: September 30, 2008
Last Updated: February 11, 2016

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on May 22, 2017