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Post Operative Atrial Fibrillation (POAF) is the most common complication of cardiac surgery. POAF incidence can exceed 50% depending on the patient baseline characteristics and surgery type. Patients with POAF tend to have worse acute and long-term clinical outcomes. BoxX-NoAF is a randomized trial to evaluate if prophylactic ablation and exclusion of the Left Atrial Appendage at the time of other routine cardiac surgery can reduce the incidence of post operative AF and clinical AF during long term follow up in patients who have not yet developed AF but are at risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Index cardiac surgery + Ablation + Left Atrial Appendage Exclusion with AtriClip |
|
| Control | No Intervention | Index cardiac surgery only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System | Device | Box lesion ablation with the Isolator Synergy EnCompass Clamp System and LAAE using the AtriClip LAA Exclusion System at the time of planned cardiac surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint | The occurrence of clinically relevant post operative AF (POAF) | 30 days post index cardiac surgical procedure |
| Primary Safety Endpoint | The composite of the following events:
| 30 days post index cardiac surgical procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Powered Secondary Effectiveness Endpoint | The time to first occurrence of clinical atrial fibrillation from 30 days after index cardiac surgical procedure through 3-years | 3 years post index cardiac surgical procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BoxX-NoAF Trial Inbox | Contact | 1 (513) 755-4100 | BoxXNoAF@atricure.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Bernards Medical Center | Recruiting | Jonesboro | Arkansas | 72401 | United States |
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| Sharp Memorial Hospital | Recruiting | San Diego | California | 92123 | United States |
|
| Morton Plant Hospital - BayCare Health System, Inc. | Recruiting | Clearwater | Florida | 33759 | United States |
|
| St. Joseph's Hospital - BayCare Health System, Inc. | Recruiting | Clearwater | Florida | 33759 | United States |
|
| Orlando Health, Inc. | Recruiting | Orlando | Florida | 32806 | United States |
|
| Sarasota Memorial Hospital | Recruiting | Sarasota | Florida | 34239 | United States |
|
| Emory University | Recruiting | Atlanta | Georgia | 30308 | United States |
|
| Piedmont Hospital | Recruiting | Atlanta | Georgia | 30309 | United States |
|
| Wellstar Health System | Recruiting | Marietta | Georgia | 30062 | United States |
|
| Northwestern Memorial Hospital | Recruiting | Chicago | Illinois | 60611 | United States |
|
| Norton Healthcare | Recruiting | Louisville | Kentucky | 40205 | United States |
|
| MedStar Health Research Institute | Recruiting | Baltimore | Maryland | 21218 | United States |
|
| Corewell Health | Recruiting | Grand Rapids | Michigan | 49503 | United States |
|
| Trinity Health | Recruiting | Ypsilanti | Michigan | 48197 | United States |
|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| Northwell Health | Recruiting | Manhasset | New York | 11030 | United States |
|
| New York Presbyterian Hospital/Columbia University Irving Medical Center | Not yet recruiting | New York | New York | 10032 | United States |
|
| Bethesda North Hospital | Recruiting | Cincinnati | Ohio | 45242 | United States |
|
| Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| Allegheny-Singer Research Institute | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
|
| Ascension Saint Thomas | Recruiting | Nashville | Tennessee | 37205 | United States |
|
| Baylor Research Institute - Baylor Scott and White Research Institute | Recruiting | Dallas | Texas | 75204 | United States |
|
| Charleston Area Medical Center | Recruiting | Charleston | West Virginia | 25304 | United States |
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| Aspirus Hospital | Recruiting | Wausau | Wisconsin | 54401 | United States |
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| Hamilton General Hospital | Recruiting | Hamilton | Ontario | L8L 2X2 | Canada |
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| London Health Sciences Centre, University Hospital | Recruiting | London | Ontario | N6A 5A5 | Canada |
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| Montreal Heart Institute | Recruiting | Montreal | Quebec | H1T 1C8 | Canada |
|
| 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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