Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation

NCT00765089 | Completed Phase 4 DMC

• 1 other identifier: 0508144
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Reduced incidence of Postoperative Atrial fibrillation

  12 hours

Study Arms (2)

Pulmonary Vein isolation

EXPERIMENTAL

Patients in this arm will receive pulmonary vein isolation during surgery

Procedure: Isolation of pulmonary veins with Bipolar radiofrequency ablation

Standard of care

NO INTERVENTION

Subjects in this arm will receive standard of care and no pulmonary vein isolation

Interventions

Isolation of pulmonary veins with Bipolar radiofrequency ablation PROCEDURE

Pulmonary Vein isolation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who require an isolated elective CABG surgery on CPB.
• Both male and female patients of age 18 years to 90 years.

You may not qualify if:

• Pre existing atrial fibrillation or history of previous atrial fibrillation.
• Inability to provide informed consent.
• Pregnant or nursing patients.
• Reoperative sternotomy
• Emergency CABG surgery.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15102, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 2, 2008
• Study Start: December 1, 2005
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 12, 2016

Record last verified: 2016-02

Locations

US (1)