Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation

Postoperative Atrial Fibrillation Clinical Trial

Official title:

Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765089
• Other study ID #: 0508144
• Status: Completed
• Phase: Phase 4
• First received: September 30, 2008
• Last updated: February 11, 2016
• Start date: December 2005
• Est. completion date: March 2010

Study information

• Verified date: February 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Postoperative Atrial Fibrillation

Intervention

Procedure:
• Isolation of pulmonary veins with Bipolar radiofrequency ablation

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced incidence of Postoperative Atrial fibrillation		12 hours	No