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Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00765089
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : February 12, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Postoperative Atrial Fibrillation Procedure: Isolation of pulmonary veins with Bipolar radiofrequency ablation Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation
Study Start Date : December 2005
Primary Completion Date : March 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Eligibility Criteria

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

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.
Contacts and Locations

Information from the National Library of Medicine

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): NCT00765089


Locations
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
ClinicalTrials.gov Identifier: NCT00765089     History of Changes
Other Study ID Numbers: 0508144
First Posted: October 2, 2008    Key Record Dates
Last Update Posted: February 12, 2016
Last Verified: February 2016

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