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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Argon gas probe | Experimental | Cryomaze procedure using Argon gas probe |
|
| Nitrous oxide probe | Active Comparator | Cryomaze procedure using Nitrous oxide probe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryomaze procedure using Nitrous oxide | Device | Cryomaze procedure using Nitrous oxide |
|
| Measure | Description | Time Frame |
|---|---|---|
| recurrence of atrial fibrillation | Treatment failure | one year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pyo Won Park, MD,PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 7, 2019 | |
| Reset | Oct 29, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 7, 2019 | Oct 29, 2019 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Cryomaze procedure using Argon | Device | Cryomaze procedure using Argon |
|
|
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |