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| Name | Class |
|---|---|
| Biosense Webster, Inc. | INDUSTRY |
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The purpose of this study is to compare the efficacy of catheter ablation for atrial fibrillation between contact force-guided and impedance-guided annotation using automated annotation system (Visitag™). Patients who receive atrial fibrillation ablation are randomly assigned in the same number to two groups with impedance guided ablation and contact force guided ablation using contact force sensing catheter (THERMOCOOL® SMARTTOUCH™ catheter, Biosense Webster, Inc., Diamond Bar, CA).
During atrial fibrillation ablation, the location where ablation is conducted is displayed through annotation tags using 3D system to recognize energy delivery is done at the area. However this annotation method was unable to identify how effectively the ablation is done. To remedy this disadvantage, automated annotation system (VisiTagâ„¢ module, Biosense Webster, Inc., Diamond Bar, CA) was recently developed to make an automatic annotation when all pre-defined criteria are satisfied. But study on the clinical effects of this system is insufficient.
The purpose of this study is to compare the efficacy of catheter ablation for atrial fibrillation between contact force-guided and impedance-guided annotation using automated annotation system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Impedance Guided Ablation Group | Experimental | Impedance guided ablation group performs pulmonary vein(PV) isolation guided by annotation criteria with minimum time of 10 seconds, maximum range of 2 mm, and minimum impedance decrease over 5 Ohms instead of CF parameters. In the impedance guided group, operators are blinded to contact force data during PV isolation. |
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| Contact Forced Guided Ablation Group | Active Comparator | Contact force(CF) guided ablation group performs pulmonary vein (PV) isolation guided by automated annotation criteria with minimum time of 10 seconds, maximum range of 2mm, CF over time of 50% and minimum CF of 10 g. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation | Device | Catheter ablation for atrial fibrillation |
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| Measure | Description | Time Frame |
|---|---|---|
| Acute success rate of pulmonary vein isolation obtained after initial circumferential ablation line around pulmonary veins | Acute success is defined as confirmation of entrance block in all pulmonary veins | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of any atrial arrhythmias (atrial fibrillation or atrial tachycardia) | 12 months | |
| Procedure time | 6 hours | |
| Ablation time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyoung-Seob Park, MD | Keimyung University Dongsan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keimyung University Dongsan Medical Center | Daegu | 700-712 | South Korea |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 6 hours |
| Average contact force of each ablation lesion | 6 hours |
| Impedance drop of each ablation lesion | 6 hours |
| Force time integral of each ablation lesion | 6 hours |
| D013568 |
| Pathological Conditions, Signs and Symptoms |