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| Name | Class |
|---|---|
| AtriCure, Inc. | INDUSTRY |
| Virginia Commonwealth University | OTHER |
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Specific Aims: The primary objective of this registry is to determine the percentage of patients who are free from atrial fibrillation (AF) at 6 and 12 months following a surgical ablation procedure when the patient has a history of failing one or more previous catheter based ablations for AF. The first 3 months following surgical ablation will be a blanking period; any arrhythmia occurring during this time will not be used to determine success.
Primary Objectives:
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical ablation | Patients undergoing surgical ablation for Atrial Fibrillation that have failed one or more previous attempts at catheter ablation for Atrial Fibrillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Totally Thoracoscopic Maze | Procedure | Epicardial pulmonary vein isolation with additional lesions as determined to be necessary by physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the efficacy of surgical ablation for AF at 6, & 12 months both on and off of antiarrhythmic drugs following a failed catheter based ablation for AF. | 1 year post operatively | |
| Record and evaluate all complications associated with the surgical procedure. | 1 year post operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate usage of anticoagulants at 6 and 12 months. | 1 year post operatively | |
| Determine the % of Pulmonary Veins that were electrically isolated by intra-operative, pre-surgical mapping. | 1 year post operatively |
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Inclusion Criteria:
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Patients that have undergone surgical ablation after failing catheter based ablation at investigator sites
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| Name | Affiliation | Role |
|---|---|---|
| James R Edgerton, MD | Cardiopulmonary Research Science and Technology Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endovascular Research | Springfield | Oregon | 97477 | United States | ||
| Cardiopulmonary Research Science and Technology Institute |
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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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| ID | Term |
|---|---|
| D000079042 | Maze Procedure |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
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no biospecimens will be obtained.
| Dallas |
| Texas |
| 75230 |
| United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D019616 | Thoracic Surgical Procedures |