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

Primary Purpose

Complication of Coronary Artery Bypass Graft, Atrial Fibrillation

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Two sites cryoablation

About this trial

This is an interventional treatment trial for Complication of Coronary Artery Bypass Graft focused on measuring Atrial fibrillation, coronary artery bypass graft, cryoablation, ganglionic plexi

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Two sites cryoablation group

Control group

Arm Description

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

No Intervention group

Outcomes

Primary Outcome Measures

freedom of atrial fibrillation or other atrial arrhythmia

check the occurrence of atrial fibrillation through EKG monitoring And bradycardia(<40/min) or tachycardia(>110/min) does not occur

Secondary Outcome Measures

Full Information

NCT ID

NCT02035163

First Posted

January 10, 2014

Last Updated

April 4, 2019

Sponsor

Yong Seog Oh

1. Study Identification

Unique Protocol Identification Number

NCT02035163

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

July 2012 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yong Seog Oh

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Complication of Coronary Artery Bypass Graft, Atrial Fibrillation

Keywords

Atrial fibrillation, coronary artery bypass graft, cryoablation, ganglionic plexi

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Two sites cryoablation group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control group

Arm Type

No Intervention

Arm Description

No Intervention group

Intervention Type

Procedure

Intervention Name(s)

Two sites cryoablation

Intervention Description

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

Primary Outcome Measure Information:

Title

freedom of atrial fibrillation or other atrial arrhythmia

Description

check the occurrence of atrial fibrillation through EKG monitoring And bradycardia(<40/min) or tachycardia(>110/min) does not occur

Time Frame

5 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sung Hwan Kim, MD

Phone

82-10-9109-8957

sunghwan@catholic.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yong Seog Oh, Ph.D

Organizational Affiliation

Seoul St. Mary's Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Seoul

State/Province

Seo Cho Gu

ZIP/Postal Code

137-701

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sung Hwan Kim, MD

Phone

82-10-9109-8957

sunghwan@catholic.ac.kr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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