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The purpose of this trial is to assess acute safety and performance of the Multi-electrode Linear Type Catheter in conjunction with generator software V2.4.0 or above when used for the treatment of Persistent Atrial Fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endocardial Ablation Procedure | Experimental | ablation with Linear type catheter |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endocardial Ablation Procedure | Device |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Early Onset of Primary Adverse Events | Incidence of early onset (within 7 days of ablation procedure) primary Adverse Events | Within 7 days |
| Confirmation of entrance block | Acute procedural success defined as: Confirmation of entrance block in all targeted PVs after adenosine and /or isoproterenol challenge (taking into account a 30 minute waiting period from the last RF application at a PV target before verification) | Intraoperative |
| Confirmation of bi-directional block | Acute procedural success defined as: Confirmation of bi-directional block in all linear lesions | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Serious Adverse Device Effects (SADEs) | Incidence of Serious Adverse Device Effects (SADEs) during follow-up | 1 Year |
| Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia |
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Inclusion Criteria:
Exclusion Criteria:
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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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Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia recurrence at 3, 6 and 12 months post-procedure
| 3, 6 and 12 months post-procedure |
| D013568 |
| Pathological Conditions, Signs and Symptoms |