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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01812356
First Posted: March 18, 2013
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Samsung Medical Center
  Purpose

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 Valve Device: Cryomaze procedure using Nitrous oxide Device: Cryomaze procedure using Argon

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]
    Treatment failure


Secondary Outcome Measures:
  • Postoperative stroke [ Time Frame: one year ]
    Thromboembolism

  • Atrial arrhythmia events [ Time Frame: one year ]
    AF recurrence, the need for antiarrhythmic drugs for symptoms, permanent pacemaker insertion, and the need for cardioversion

  • Cardiac related death [ Time Frame: one year ]
    Including sudden death

  • heart failure [ Time Frame: one year ]
    heart failure requiring admission

  • Reoperation [ Time Frame: one year ]
    reoperation due to heart problems

  • Intracranial hemorrhage [ Time Frame: one year ]
    bleeding complication involving brain


Enrollment: 60
Study Start Date: March 2013
Study Completion Date: December 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
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
Cryomaze procedure using Nitrous oxide
Other Name: Atricure cryoprobe

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812356


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Pyo Won Park, MD,PhD Samsung Medical Center
  More Information

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01812356     History of Changes
Other Study ID Numbers: 2012-11-088
First Submitted: March 8, 2013
First Posted: March 18, 2013
Last Update Posted: August 24, 2017
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Samsung Medical Center:
Atrial fibrillation
maze operation
cryoablation

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