Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation

University of Pittsburgh

Status and phase: Completed; Phase 4

Conditions: Postoperative Atrial Fibrillation

Treatments: Procedure: Isolation of pulmonary veins with Bipolar radiofrequency ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT00765089

0508144

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Pulmonary Vein isolation

Experimental group

Description:

Patients in this arm will receive pulmonary vein isolation during surgery

Treatment:

Procedure: Isolation of pulmonary veins with Bipolar radiofrequency ablation

Standard of care

No Intervention group

Description:

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