Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation
Primary Purpose
Postoperative Atrial Fibrillation
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Isolation of pulmonary veins with Bipolar radiofrequency ablation
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Atrial Fibrillation
Eligibility Criteria
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.
Sites / Locations
- University of Pittsburgh Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pulmonary Vein isolation
Standard of care
Arm Description
Patients in this arm will receive pulmonary vein isolation during surgery
Subjects in this arm will receive standard of care and no pulmonary vein isolation
Outcomes
Primary Outcome Measures
Reduced incidence of Postoperative Atrial fibrillation
Secondary Outcome Measures
Full Information
NCT ID
NCT00765089
First Posted
September 30, 2008
Last Updated
February 11, 2016
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT00765089
Brief Title
Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation
Official Title
Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Atrial Fibrillation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary Vein isolation
Arm Type
Experimental
Arm Description
Patients in this arm will receive pulmonary vein isolation during surgery
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Subjects in this arm will receive standard of care and no pulmonary vein isolation
Intervention Type
Procedure
Intervention Name(s)
Isolation of pulmonary veins with Bipolar radiofrequency ablation
Primary Outcome Measure Information:
Title
Reduced incidence of Postoperative Atrial fibrillation
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15102
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation
We'll reach out to this number within 24 hrs