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This is a multi center, non-randomized, prospective, open label, clinical trial evaluating the safety and efficacy of the nContact Surgical Numeris-AF Tethered Coagulation System when used to treat patients with persistent and longstanding persistent AF during concomitant cardiac surgery.
The purpose of this study is to determine the safety and efficacy of the Numeris-AF Tethered Coagulation System with VisiTrax when used to treat persistent and longstanding persistent Atrial Fibrillation(AF)during concomitant cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Numeris-AF Tethered Coagulation System with VisiTrax | Device | Surgical radiofrequency (RF) epicardial ablation using the nContact Numeris-AF Tethered Coagulation System |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary effectiveness endpoint will be assessed as number of subjects free from AF and free of all Class I and III Anti Arrhythmic Drugs (AADs) through 9 months post procedure. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary effectiveness endpoint: Proportion of subjects free from AF regardless of their Class I and III AADs status through 9 months post procedure. | 9 months | |
| Secondary effectiveness endpoint: Proportion of subjects free of AF/ AFL / AT and off all Class I and Class III AADs. |
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Inclusion Criteria:
Age > 18 years; < 80 years
Left atrium =< 6.0 cm
Documented persistent or longstanding persistent AF
History of AF =< 10 years
Scheduled for a concomitant cardiac procedure
Provided written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Garrett, M.D. | Baptist Memorial Hospital - Memphis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Venice Regional Medical Center | Venice | Florida | 34285-3298 | United States | ||
| Baptist Memorial Hospital |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D013927 | Thrombosis |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 9 months |
| Memphis |
| Tennessee |
| 38120 |
| United States |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |