Atrial Fibrillation, Valve
Conditions
Keywords
Atrial fibrillation, maze operation, cryoablation
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.
Interventions
DEVICECryomaze procedure using Nitrous oxide
Cryomaze procedure using Nitrous oxide
DEVICECryomaze procedure using Argon
Cryomaze procedure using Argon
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| recurrence of atrial fibrillation | one year | Treatment failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Postoperative stroke | one year | Thromboembolism |
| Reoperation | one year | reoperation due to heart problems |
| Intracranial hemorrhage | one year | bleeding complication involving brain |
| heart failure | one year | heart failure requiring admission |
Countries
South Korea
Outcome results
None listed