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

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ClinicalTrials.gov Identifier: NCT02035163
Recruitment Status : Recruiting
First Posted : January 14, 2014
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Yong Seog Oh, Seoul St. Mary's Hospital

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.


Condition or disease Intervention/treatment Phase
Complication of Coronary Artery Bypass Graft Atrial Fibrillation Procedure: Two sites cryoablation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Atrial Fibrillation Prevention in Post Coronary Artery Bypass Graft Surgery With Cryoablation for Ganglionic Plexi
Study Start Date : July 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Two sites cryoablation group
Two ganglionic plexi around atrium was performed with 90-second cryoablation.
Procedure: Two sites cryoablation
Two ganglionic plexi around atrium was performed with 90-second cryoablation.
No Intervention: Control group
No Intervention group



Primary Outcome Measures :
  1. freedom of atrial fibrillation or other atrial arrhythmia [ Time Frame: 5 days after surgery ]
    check the occurrence of atrial fibrillation through EKG monitoring And bradycardia(<40/min) or tachycardia(>110/min) does not occur



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035163


Contacts
Contact: Sung Hwan Kim, MD 82-10-9109-8957 sunghwan@catholic.ac.kr

Locations
Korea, Republic of
The Catholic University of Korea, Seoul St Mary's Hospital Recruiting
Seoul, Seo cho Gu, Korea, Republic of, 137-701
Contact: Sung Hwan Kim, MD    82-10-9109-8957    sunghwan@catholic.ac.kr   
Sponsors and Collaborators
Yong Seog Oh
Investigators
Study Chair: Yong Seog Oh, Ph.D Seoul St. Mary's Hospital

Responsible Party: Yong Seog Oh, MD, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT02035163     History of Changes
Other Study ID Numbers: APIP
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yong Seog Oh, Seoul St. Mary's Hospital:
Atrial fibrillation
coronary artery bypass graft
cryoablation
ganglionic plexi

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes