Atrial Fibrillation Prevention in Post Coronary Artery By... | NCT02035163

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

NCT02035163

Sponsor

Yong Seog Oh

Status

Withdrawn

Last Update Posted

Apr 23, 2024Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Complication of Coronary Artery Bypass Graft
Atrial Fibrillation

Interventions

Two sites cryoablation

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Jan 10, 2014

First Submission Date that Met QC Criteria

Jan 10, 2014

First Posted Date

Jan 14, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2024

Last Update Posted Date

Apr 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Two sites cryoablation	Procedure	Two ganglionic plexi around atrium was performed with 90-second cryoablation.	Two sites cryoablation group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yong Seog Oh, Ph.D	Seoul St. Mary's Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Catholic University of Korea, Seoul St Mary's Hospital		Seoul	Seo Cho Gu	137-701	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided