NCT02035163

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

7.4 years

First QC Date

January 10, 2014

Last Update Submit

April 20, 2024

Conditions

Complication of Coronary Artery Bypass GraftAtrial Fibrillation

Keywords

Atrial fibrillationcoronary artery bypass graftcryoablationganglionic plexi

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Two sites cryoablation group

ACTIVE COMPARATOR

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

Procedure: Two sites cryoablation

Control group

NO INTERVENTION

No Intervention group

Interventions

Two sites cryoablationPROCEDURE

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

Two sites cryoablation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • coronary artery graft bypass patient
  • sinus rhythm

You may not qualify if:

  • Patients using antiarrhythmic
  • severe hypotension after surgery ( systolic blood pressure \<90mmHg)
  • history of atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, Seo Cho Gu, 137-701, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yong Seog Oh, Ph.D

    Seoul St. Mary's Hospital

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 14, 2014

Study Start

July 1, 2012

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

April 23, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)