Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation

Phase 4

Completed

• Conditions: Postoperative Atrial Fibrillation
• Interventions: Procedure: Isolation of pulmonary veins with Bipolar radiofrequency ablation

• Registration Number: NCT00765089
• Lead Sponsor: University of Pittsburgh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-09-30
• Study First Posted: 2008-10-02
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmonary Vein isolation	Isolation of pulmonary veins with Bipolar radiofrequency ablation	Patients in this arm will receive pulmonary vein isolation during surgery

Primary Outcome Measures

Name	Time	Method
Reduced incidence of Postoperative Atrial fibrillation	12 hours

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States