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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
March 8, 2013
March 18, 2013
August 24, 2017
March 2013
November 2015   (Final data collection date for primary outcome measure)
recurrence of atrial fibrillation [ Time Frame: one year ]
Treatment failure
recurrence of atrial fibrillation [ Time Frame: one year ]
Complete list of historical versions of study NCT01812356 on ClinicalTrials.gov Archive Site
  • 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
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: None (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 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
Sexes Eligible for Study: All
18 Years to 75 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