Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01812356
First received: March 8, 2013
Last updated: October 28, 2014
Last verified: March 2013

March 8, 2013
October 28, 2014
March 2013
March 2015   (final data collection date for primary outcome measure)
recurrence of atrial fibrillation [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01812356 on ClinicalTrials.gov Archive Site
Not Provided
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 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Valve
  • Device: Cryomaze procedure using Nitrous oxide
    Other Name: Atricure cryoprobe
  • Device: 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.
 
Recruiting
60
March 2016
March 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
Both
30 Years to 70 Years
No
Contact: Pwo Won Park, MD, PhD 82-2-3410-3481 pwpark@skku.edu
Korea, Republic of
 
NCT01812356
2012-11-088
Not Provided
Samsung Medical Center
Samsung Medical Center
Not Provided
Not Provided
Samsung Medical Center
March 2013

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