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OpenTrials
Completed

NCT Number: NCT00765089

Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation

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.

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Key information

Conditions

Postoperative Atrial Fibrillation

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15102, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pre existing atrial fibrillation or history of previous atrial fibrillation.
  • Inability to provide informed consent.
  • Pregnant or nursing patients.
  • Reoperative sternotomy
  • Emergency CABG surgery.

Treatment and study plan

Isolation of pulmonary veins with Bipolar radiofrequency ablation

Procedure

Primary outcomes

  1. Reduced incidence of Postoperative Atrial fibrillation

    Time frame: 12 hours

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Oct 2, 2008
Registry last updated
Feb 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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