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

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01812356
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
45
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: Cryomaze procedure using Nitrous oxide
  • Device: Cryomaze procedure using Argon
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
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
Study Start Date :
Mar 1, 2013
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Argon gas probe

Cryomaze procedure using Argon gas probe

Device: Cryomaze procedure using Argon
Cryomaze procedure using Argon
Other Names:
  • 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 Names:
  • Atricure cryoprobe

    		•

    Outcome Measures

    Primary Outcome Measures

    1. recurrence of atrial fibrillation [one year]

      Treatment failure

    Secondary Outcome Measures

    1. Postoperative stroke [one year]

      Thromboembolism

    2. Atrial arrhythmia events [one year]

      AF recurrence, the need for antiarrhythmic drugs for symptoms, permanent pacemaker insertion, and the need for cardioversion

    3. Cardiac related death [one year]

      Including sudden death

    4. heart failure [one year]

      heart failure requiring admission

    5. Reoperation [one year]

      reoperation due to heart problems

    6. Intracranial hemorrhage [one year]

      bleeding complication involving brain

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT01812356
    Other Study ID Numbers:
    • 2012-11-088
    First Posted:
    Mar 18, 2013
    Last Update Posted:
    Aug 24, 2017
    Last Verified:
    Mar 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Samsung Medical Center
    Atrial fibrillation
    maze operation
    cryoablation
    Additional relevant MeSH terms:
    Atrial Fibrillation
    Nitrous Oxide

    Study Results

    No Results Posted as of Aug 24, 2017