Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-01 @ 2:47 PM
Study NCT ID:
NCT01812356
Status:
COMPLETED
Last Update Posted:
2017-08-24
First Post:
2013-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Concomitant Cryomaze Procedure Using Nitreous Oxide Cryoprobe: Comparison With Argon Based Cryoprobe
Sponsor:
Samsung Medical Center
Organization:
Study Overview
Official Title:
Study of Cryomaze Procedure Using Nitrous Oxide Versus Argon Gas
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: