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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01812356
First received: March 8, 2013
Last updated: January 11, 2017
Last verified: March 2016
March 8, 2013
January 11, 2017
March 2013
November 2015   (Final data collection date for primary outcome measure)
recurrence of atrial fibrillation [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT01812356 on ClinicalTrials.gov Archive Site
  • Postoperative stroke [ Time Frame: one year ]
  • Postoperative pacemaker insertion [ Time Frame: one year ]
  • Cardiac related death [ Time Frame: one year ]
  • Postoperative heart failure [ Time Frame: one year ]
Not Provided
Not Provided
Not Provided
 
The Concomitant Cryomaze Procedure Using Nitreous Oxide Cryoprobe: Comparison With Argon Based Cryoprobe
Study of Cryomaze Procedure Using Nitrous Oxide Versus Argon Gas

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Valve
  • Device: Cryomaze procedure using Nitrous oxide
    Cryomaze procedure using Nitrous oxide
    Other Name: Atricure cryoprobe
  • Device: Cryomaze procedure using Argon
    Cryomaze procedure using Argon
    Other Name: ATS medtronic probe
  • Experimental: Argon gas probe
    Cryomaze procedure using Argon gas probe
    Intervention: Device: Cryomaze procedure using Argon
  • Active Comparator: Nitrous oxide probe
    Cryomaze procedure using Nitrous oxide probe
    Intervention: Device: Cryomaze procedure using Nitrous oxide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2016
November 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01812356
2012-11-088
No
Not Provided
Plan to Share IPD: No
Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Pyo Won Park, MD,PhD Samsung Medical Center
Samsung Medical Center
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP