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Compare the efficacy of the left atrial Cox-Maze IV lesion set versus the Tampa 2 lesion set versus the EnCompass ablation alone, in the surgical treatment of atrial fibrillation at one year post-operatively.
This is a single center prospective, randomized trial to compare the outcomes, specifically the freedom from atrial fibrillation at one year, and possibly up to five years, of three different approaches to the cardiac surgical management of atrial fibrillation.
Several strategies to accomplish surgical ablation are acceptable and have been shown retrospectively to be successful. The Cox-Maze bi-atrial, left and right atrial lesions, ablation (whether III or IV) remains the gold standard by which all surgical ablations are compared. Further refinement in ablation technology and research has further suggested there is no difference between a left atrial ablation alone or bi-atrial ablation lesion set. For left atrial ablation alone, existent therapeutic options, which all meet equivalent standard of care, include a left atrial Cox-Maze IV , a Tampa 2 lesion set or utilizing a "box lesion" alone. Currently, there are no randomized, clinical trials demonstrating better efficacy (freedom from atrial fibrillation post-operatively) of one ablation strategy over another in patients undergoing cardiac surgery.
The rationale for the study is to demonstrate whether one ablation technique is more efficacious in the surgical treatment of AF. Should one technique prove superior it may clarify the question of which ablation strategy to utilize and encourage surgeons to implement a consistent approach to surgical ablation.
To our knowledge this study would be the first prospective, randomized trial in the United States comparing surgical lesion sets in the concomitant management of atrial fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cox-Maze IV | Active Comparator | Lesion created around the pulmonary vein ostia (openings). Lesion to posterior (back) of the mitral annulus (fibrous ring around the mitral valve leaflets). Lesion from the 'box' to the left atrial appendage. There is also one lesion on the outside of the heart at the coronary sinus (main vein draining the heart)- not shown in this picture due to being on the outside of the heart. The Left Atrial Appendage will also be either excluded or removed. |
|
| Tampa 2 | Active Comparator | Lesion created around the pulmonary vein ostia (openings). Lesion from the 'box' to the left atrial appendage Lesion from the left atrial appendage to the anterior (front) of the mitral annulus (fibrous ring around the mitral valve leaflets). This lesion is done through the left atrial appendage. The Left Atrial Appendage will also be either excluded or removed. |
|
| Encompass Alone | Active Comparator | Lesion created around the pulmonary vein ostia (openings). The Left Atrial Appendage will also be either excluded or removed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atrial Fibrillation Ablation | Procedure | Ablation of the heart to reduce Afib Occurrence |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from Atrial Fibrillation | Freedom from atrial fibrillation at 30 days and one year | 30 days and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Prescribed Antiarrhythmic and anticoagulant drugs | Antiarrhythmic and anticoagulant drugs at 7days and one year post surgery | 7 days and 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Willekes, MD | Corewell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corewell Health West | Grand Rapids | Michigan | 49503 | United States |
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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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This is a single enter prospective, randomized trial to compare the outcomes, specifically the freedom from atrial fibrillation at one year, and possibly up to five years, of three different approaches (Cox-Maze IV, Tampa 2, Encompass) to the cardiac surgical management of atrial fibrillation. All patients undergoing an elective, cardiac surgical procedure with documented preoperative AF, either paroxysmal or persistent, with a planned surgical ablation are potential candidates.
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| D013568 |
| Pathological Conditions, Signs and Symptoms |