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

Not Applicable

Completed

• Conditions: Valve; Atrial Fibrillation
• Interventions: Device: Cryomaze procedure using Argon; Device: Cryomaze procedure using Nitrous oxide

• Registration Number: NCT01812356
• Lead Sponsor: Samsung Medical Center

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-08
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-18
• Primary Completion: 2015-11
• Status Verified: 2016-03
• Study Completion: 2016-12
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• requiring concomitant maze operation with valve surgery (persistent atrial fibrillation)
• between 18 and 75 years old

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Argon gas probe	Cryomaze procedure using Argon	Cryomaze procedure using Argon gas probe
Nitrous oxide probe	Cryomaze procedure using Nitrous oxide	Cryomaze procedure using Nitrous oxide probe

Primary Outcome Measures

Name	Time	Method
recurrence of atrial fibrillation	one year	Treatment failure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of