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This is a multi-center, prospective open label, feasibility study evaluating the safety and efficacy of the combined ablation procedure for the treatment of longstanding persistent atrial fibrillation.
The purpose of this feasibility study is to evaluate the safety and efficacy of the epicardial / endocardial combined procedure using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the St. Jude Medical Therapy™ Cool Path™ Ablation Catheter endocardially to treat longstanding persistent Atrial Fibrillation (AF) patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Numeris-AF Guided Coagulation System | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Numeris®-AF Guided Coagulation System with VisiTrax® | Device | Combined epicardial / endocardial procedure using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the St. Jude Medical Therapy™ Cool Path™ Ablation Catheter endocardially. |
| Measure | Description | Time Frame |
|---|---|---|
| AF free, off all Class I and III Anti Arrhythmic Drugs (AADs) | The primary efficacy data will be an evaluation of the number of subjects free from AF and free of all Class I and III Anti Arrhythmic Drugs (AADs) from 3 months through 12 months post procedure. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| AF free regardless of the Class I and III AADs status | The secondary efficacy data will be an assessment of the number of subjects free from AF regardless of their Class I and III AADs status from 3 months through 12 months post procedure. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Care Group, St Vincent Hospital | Indianapolis | Indiana | 46250 | United States | ||
| Baptist Memorial Hospital |
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| Memphis |
| Tennessee |
| 38120 |
| United States |
| Texas Cardiac Arrhythmia Institute, St. David's Hospital | Austin | Texas | 78705 | United States |
| Cardiothoracic Surgical Associates, CJW Medical Center | Richmond | Virginia | 23225 | United States |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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