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Completed

NCT Number: NCT01812356

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cryomaze procedure using Nitrous oxide

Device

Cryomaze procedure using Nitrous oxide

Other names: Atricure cryoprobe

Cryomaze procedure using Argon

Device

Cryomaze procedure using Argon

Other names: ATS medtronic probe

Primary outcomes

  1. recurrence of atrial fibrillation

    Time frame: one year

    Treatment failure

Secondary outcomes

  1. Postoperative stroke

    Time frame: one year

    Thromboembolism

  2. Atrial arrhythmia events

    Time frame: one year

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

  3. Cardiac related death

    Time frame: one year

    Including sudden death

  4. heart failure

    Time frame: one year

    heart failure requiring admission

  5. Reoperation

    Time frame: one year

    reoperation due to heart problems

  6. Intracranial hemorrhage

    Time frame: one year

    bleeding complication involving brain

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Study of Cryomaze Procedure Using Nitrous Oxide Versus Argon Gas

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Mar 18, 2013
Registry last updated
Aug 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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