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

Atrial Fibrillation Clinical Trial

Official title:

Study of Cryomaze Procedure Using Nitrous Oxide Versus Argon Gas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01812356
• Other study ID #: 2012-11-088
• Status: Completed
• Phase: N/A
• First received: March 8, 2013
• Last updated: August 22, 2017
• Start date: March 2013
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Valve

Intervention

Device:
• Cryomaze procedure using Nitrous oxide
Cryomaze procedure using Nitrous oxide
• Cryomaze procedure using Argon
Cryomaze procedure using Argon

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence of atrial fibrillation	Treatment failure	one year
Secondary	Postoperative stroke	Thromboembolism	one year
Secondary	Atrial arrhythmia events	AF recurrence, the need for antiarrhythmic drugs for symptoms, permanent pacemaker insertion, and the need for cardioversion	one year
Secondary	Cardiac related death	Including sudden death	one year
Secondary	heart failure	heart failure requiring admission	one year
Secondary	Reoperation	reoperation due to heart problems	one year
Secondary	Intracranial hemorrhage	bleeding complication involving brain	one year