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The Concomitant Cryomaze Procedure Using Nitreous Oxide Cryoprobe: Comparison With Argon Based Cryoprobe

Primary Purpose

Atrial Fibrillation, Valve

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cryomaze procedure using Nitrous oxide
Cryomaze procedure using Argon
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, maze operation, cryoablation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • requiring concomitant maze operation with valve surgery (persistent atrial fibrillation)
  • between 18 and 75 years old

Exclusion Criteria:

  • previous cardiac surgery
  • Behcet disease
  • Takayasu's arteritis
  • Infective endocarditis
  • Congenital heart disease
  • left atrial size over 80mm
  • moderate or greater functional tricuspid regurgitation

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Argon gas probe

Nitrous oxide probe

Arm Description

Cryomaze procedure using Argon gas probe

Cryomaze procedure using Nitrous oxide probe

Outcomes

Primary Outcome Measures

recurrence of atrial fibrillation
Treatment failure

Secondary Outcome Measures

Postoperative stroke
Thromboembolism
Atrial arrhythmia events
AF recurrence, the need for antiarrhythmic drugs for symptoms, permanent pacemaker insertion, and the need for cardioversion
Cardiac related death
Including sudden death
heart failure
heart failure requiring admission
Reoperation
reoperation due to heart problems
Intracranial hemorrhage
bleeding complication involving brain

Full Information

First Posted
March 8, 2013
Last Updated
August 22, 2017
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01812356
Brief Title
The Concomitant Cryomaze Procedure Using Nitreous Oxide Cryoprobe: Comparison With Argon Based Cryoprobe
Official Title
Study of Cryomaze Procedure Using Nitrous Oxide Versus Argon Gas
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is compare the surgical convenience and early and long-term outcomes of cryomaze procedure using nitrous oxide with using Argon gas. The investigators will analyze the pathologic findings of atrial tissue after cryoablation using two probes and early and long-term outcomes with Holter monitoring. Atrial fibrillation burden 3 months and 1 year postoperatively and atrial activity will be checked.
Detailed Description
The investigators have used the Medtronic ATS cryoprobe (Argon based) since 2009 for cryomaze procedure for treatment of atrial fibrillation combined with valvular heart disease. However, sometimes, it was inconvenient due to excess flexibility, wide lesion related to excess low temperature and time-consuming detachment from atrium after cryoablation. The investigators introduced Atricure cryoprobe (Nitreos Oxide based) in hope of overcoming these shortcomings of ATS probes last year. Up to date, the investigators have been satisfactory in terms of the surgical convenience. On the other hand, we have the questionability of transmural lesion of Atricure probe because of the higher temperature of Atricure probe compared with ATS probe. The aim of this study is compare the surgical convenience and early and long-term outcomes of cryomaze procedure using nitrous oxide with using Argon gas. The investigators will analyze the pathologic findings of atrial tissue after cryoablation using two probes and early and long-term outcomes with Holter monitoring. Atrial fibrillation burden 3 months and 1 year postoperatively and atrial activity will be checked.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Valve
Keywords
Atrial fibrillation, maze operation, cryoablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Argon gas probe
Arm Type
Experimental
Arm Description
Cryomaze procedure using Argon gas probe
Arm Title
Nitrous oxide probe
Arm Type
Active Comparator
Arm Description
Cryomaze procedure using Nitrous oxide probe
Intervention Type
Device
Intervention Name(s)
Cryomaze procedure using Nitrous oxide
Other Intervention Name(s)
Atricure cryoprobe
Intervention Description
Cryomaze procedure using Nitrous oxide
Intervention Type
Device
Intervention Name(s)
Cryomaze procedure using Argon
Other Intervention Name(s)
ATS medtronic probe
Intervention Description
Cryomaze procedure using Argon
Primary Outcome Measure Information:
Title
recurrence of atrial fibrillation
Description
Treatment failure
Time Frame
one year
Secondary Outcome Measure Information:
Title
Postoperative stroke
Description
Thromboembolism
Time Frame
one year
Title
Atrial arrhythmia events
Description
AF recurrence, the need for antiarrhythmic drugs for symptoms, permanent pacemaker insertion, and the need for cardioversion
Time Frame
one year
Title
Cardiac related death
Description
Including sudden death
Time Frame
one year
Title
heart failure
Description
heart failure requiring admission
Time Frame
one year
Title
Reoperation
Description
reoperation due to heart problems
Time Frame
one year
Title
Intracranial hemorrhage
Description
bleeding complication involving brain
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: requiring concomitant maze operation with valve surgery (persistent atrial fibrillation) between 18 and 75 years old Exclusion Criteria: previous cardiac surgery Behcet disease Takayasu's arteritis Infective endocarditis Congenital heart disease left atrial size over 80mm moderate or greater functional tricuspid regurgitation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pyo Won Park, MD,PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Concomitant Cryomaze Procedure Using Nitreous Oxide Cryoprobe: Comparison With Argon Based Cryoprobe

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