Atrial Fibrillation Prevention in Post Coronary Artery Bypass Graft Surgery With Cryoablation for Ganglionic Plexi

NCT ID: NCT02035163

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2019-12-31

Brief Summary

Atrial fibrillation after coronary artery bypass graft is a common complication.

The investigators have thought that the mechanism of temporarily postoperative atrial fibrillation is closely related to the autonomic nervous system imbalance.

In a last several years, cryoablation was substituted for atrial incision in many reports to simplify the maze procedure.

However, there has been no comparative study to delineate the feasibility of the use of cryoablation.

Detailed Description

Modified maze procedures that use energy sources for the ablation of atrial fibrillation concomitant with cardiac surgery have been shown to improve outcomes in patients with atrial fibrillation. Cryoablation of atrial fibrillation recently has been shown to lead to outcomes that were at least equivalent to those reported for other energy modalities over both short- and medium-term follow-up times.

Conditions

Complication of Coronary Artery Bypass Graft; Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Two sites cryoablation group

Two ganglionic plexi around atrium was performed with 90-second cryoablation.

Group Type: ACTIVE_COMPARATOR

Two sites cryoablation

Intervention Type: PROCEDURE

Two ganglionic plexi around atrium was performed with 90-second cryoablation.

Control group

No Intervention group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Two sites cryoablation

Two ganglionic plexi around atrium was performed with 90-second cryoablation.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• coronary artery graft bypass patient
• sinus rhythm

Exclusion Criteria

• Patients using antiarrhythmic
• severe hypotension after surgery ( systolic blood pressure <90mmHg)
• history of atrial fibrillation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yong Seog Oh

OTHER

Sponsor Role: lead

Responsible Party

Yong Seog Oh

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yong Seog Oh, Ph.D

Role: STUDY_CHAIR

Seoul St. Mary's Hospital

Locations

The Catholic University of Korea, Seoul St Mary's Hospital

Seoul, Seo Cho Gu, South Korea

Countries

South Korea

Other Identifiers

APIP

Identifier Type: -

Identifier Source: org_study_id