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

This study has been completed.
Information provided by (Responsible Party):
Samsung Medical Center Identifier:
First received: March 8, 2013
Last updated: April 13, 2016
Last verified: March 2016

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.

Condition Intervention
Atrial Fibrillation
Device: Cryomaze procedure using Nitrous oxide
Device: Cryomaze procedure using Argon

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Cryomaze Procedure Using Nitrous Oxide Versus Argon Gas

Resource links provided by NLM:

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • recurrence of atrial fibrillation [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: March 2013
Study Completion Date: February 2016
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Argon gas probe
Cryomaze procedure using Argon gas probe
Device: Cryomaze procedure using Argon
Other Name: ATS medtronic probe
Active Comparator: Nitrous oxide probe
Cryomaze procedure using Nitrous oxide probe
Device: Cryomaze procedure using Nitrous oxide
Other Name: Atricure cryoprobe


Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • requiring concomitant maze operation with valve surgery (persistent atrial fibrillation)
  • between 30 and 70 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
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Please refer to this study by its identifier: NCT01812356

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
  More Information

Responsible Party: Samsung Medical Center Identifier: NCT01812356     History of Changes
Other Study ID Numbers: 2012-11-088 
Study First Received: March 8, 2013
Last Updated: April 13, 2016
Health Authority: Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Atrial fibrillation
maze operation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents processed this record on December 02, 2016