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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study of Cryomaze Procedure Using Nitrous Oxide Versus Argon Gas

Conditions
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Atrial Fibrillation, Valve

Intervention / Treatment
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* Device: Cryomaze procedure using Nitrous oxide
* Device: Cryomaze procedure using Argon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Argon gas probe<br>Cryomaze procedure using Argon gas probe | Device: Cryomaze procedure using Argon<br>* Cryomaze procedure using Argon<br>* Other names: ATS medtronic probe;|
| Active Comparator: Nitrous oxide probe<br>Cryomaze procedure using Nitrous oxide probe | Device: Cryomaze procedure using Nitrous oxide<br>* Cryomaze procedure using Nitrous oxide<br>* Other names: Atricure cryoprobe;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence of atrial fibrillation | Treatment failure | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative stroke | Thromboembolism | one year | 
| Atrial arrhythmia events | AF recurrence, the need for antiarrhythmic drugs for symptoms, permanent pacemaker insertion, and the need for cardioversion | one year | 
| Cardiac related death | Including sudden death | one year | 
| heart failure | heart failure requiring admission | one year | 
| Reoperation | reoperation due to heart problems | one year | 
| Intracranial hemorrhage | bleeding complication involving brain | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, maze operation, cryoablation