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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02035163
• Other study ID #: APIP
• Status: Withdrawn
• Phase: N/A
• Start date: July 2012
• Est. completion date: December 2019

Study information

• Verified date: April 2024
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Complication of Coronary Artery Bypass Graft

Intervention

Procedure:
• Two sites cryoablation
Two ganglionic plexi around atrium was performed with 90-second cryoablation.

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea, Seoul St Mary's Hospital	Seoul	Seo Cho Gu

Sponsors (1)

Lead Sponsor	Collaborator
Yong Seog Oh

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 days after surgery