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Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT00765089
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : February 12, 2016
Sponsor:
Information provided by (Responsible Party):
Lawrence Wei, University of Pittsburgh

September 30, 2008
October 2, 2008
February 12, 2016
December 2005
March 2010   (Final data collection date for primary outcome measure)
Reduced incidence of Postoperative Atrial fibrillation [ Time Frame: 12 hours ]
Reduced incidence of Postoperative Atrial fibrillation
Complete list of historical versions of study NCT00765089 on ClinicalTrials.gov Archive Site
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Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Postoperative Atrial Fibrillation
Procedure: Isolation of pulmonary veins with Bipolar radiofrequency ablation
  • Experimental: Pulmonary Vein isolation
    Patients in this arm will receive pulmonary vein isolation during surgery
    Intervention: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
80
March 2010
March 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00765089
0508144
Yes
Not Provided
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Lawrence Wei, University of Pittsburgh
University of Pittsburgh
Not Provided
Not Provided
University of Pittsburgh
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP