Trial record 9 of 177 for:    Open Studies | "Coronary Artery Bypass"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Seoul St. Mary's Hospital
Sponsor:
Information provided by (Responsible Party):
Yong Seog Oh, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier:
NCT02035163
First received: January 10, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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 Intervention
Complication of Coronary Artery Bypass Graft
Atrial Fibrillation
Procedure: Two sites cryoablation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Atrial Fibrillation Prevention in Post Coronary Artery Bypass Graft Surgery With Cryoablation for Ganglionic Plexi

Resource links provided by NLM:


Further study details as provided by Seoul St. Mary's Hospital:

Primary Outcome Measures:
  • freedom of atrial fibrillation or other atrial arrhythmia [ Time Frame: 5 days after surgery ] [ Designated as safety issue: No ]
    check the occurrence of atrial fibrillation through EKG monitoring And bradycardia(<40/min) or tachycardia(>110/min) does not occur


Estimated Enrollment: 2
Study Start Date: October 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Seoul St. Mary's Hospital
Investigators
Study Chair: Yong Seog Oh, Ph.D Seoul St. Mary's Hospital
  More Information

No publications provided

Responsible Party: Yong Seog Oh, MD, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT02035163     History of Changes
Other Study ID Numbers: APIP
Study First Received: January 10, 2014
Last Updated: January 10, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on July 20, 2014