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
Sponsored by
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
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
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
No
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
No
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
Email
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
Email
sunghwan@catholic.ac.kr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Atrial Fibrillation Prevention in Post Coronary Artery Bypass Graft Surgery With Cryoablation for Ganglionic Plexi
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