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| Name | Class |
|---|---|
| Biosense Webster, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the efficacy of additional ablation targeting complex fractionated atrial electrogram area within low voltage zone identified by high resolution mapping in patients with persistent atrial fibrillation.
Fifty patients with persistent atrial fibrillation will be randomized a 1:1 ratio to each group. A test group includes those who undergoing ablation targeting low voltage areas which contains complex fractionated trial electrogram in addition to pulmonary vein isolation and a control group includes who undergoing pulmonary vein isolation only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-Voltage & CFAE guided ablation | Experimental |
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| PV Isolation Only | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulmonary vein isolation | Procedure | pulmonary vein isolation is conducted on the junction between the left atrium and pulmonary vein |
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| Measure | Description | Time Frame |
|---|---|---|
| Free from atrial arrhythmia at 12 months | Freedom from any atrial arrhythmia lasting longer than 30 seconds during 1 year follow-up after single ablation with or without the use of antiarrhythmic medications with the exclusion of the 3-month blanking period. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate | Compare complication rate between two groups | 12 months |
| Total procedure time, ablation time and fluoroscopy time | Compare total procedure time, ablation time and fluoroscopy time between two groups |
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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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| Low-Voltage & CFAE guided ablation | Procedure | In CFAE guided ablation,. Within low voltage zone, CFAE areas defined by shortest SCI and high ICL are identified.-Areas with the shortest SCI and high ICL within low voltage areas should be targeted first, followed by longer SCI regions (up to 120ms). Radiofrequency energy is delivered at target sites for 30-60 sec until the local electrogram is completely eliminated. |
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| 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |