Bipolar Radiofrequency Ablation -Role in Prevention of Postoperative Atrial Fibrillation

NCT ID: NCT00765089

Last Updated: 2016-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2010-03-31

Brief Summary

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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

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Conditions

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Postoperative Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pulmonary Vein isolation

Patients in this arm will receive pulmonary vein isolation during surgery

Group Type EXPERIMENTAL

Isolation of pulmonary veins with Bipolar radiofrequency ablation

Intervention Type PROCEDURE

Standard of care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Isolation of pulmonary veins with Bipolar radiofrequency ablation

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Lawrence Wei

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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0508144

Identifier Type: -

Identifier Source: org_study_id

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