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Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00765089
First received: September 30, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official Title: Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Reduced incidence of Postoperative Atrial fibrillation

Estimated Enrollment: 80
Study Start Date: December 2005
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765089

Contacts
Contact: Sujatha Raghu, MBBS MPH 412-647-0749 raghus@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15102
Contact: Sujatha Raghu, MBBS MPH     412-647-0749        
Principal Investigator: Lawrence Wei, MD            
Sponsors and Collaborators
University of Pittsburgh
  More Information

No publications provided

Responsible Party: Lawrence Wei / Associate Professor of Surgery, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00765089     History of Changes
Other Study ID Numbers: 0508144
Study First Received: September 30, 2008
Last Updated: September 30, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2013