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The primary objective of the TRAC-AF Registry is to capture real-world safety and effectiveness data on AtriCure devices used to conduct open concomitant and/or hybrid ablation, and management of the LAA concomitant to a cardiac ablation.
Up to 10,000 patients at up to 250 sites. Participating regions may include US, Canada, Europe, Asia Pacific and others to be determined. Registry participating sites will enroll patients that meet all inclusion criteria and no exclusion criteria without preselection or bias. Each patient will be followed for a period of up to ten (10) years after their procedure according to the standard practice at the enrolling center. There will be no additional visits, nor procedures, for subjects who participate in the registry.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Concomitant Surgical Ablation Procedures | Device | AtriCure's Open Concomitant Surgical Ablation Devices used for the management of Atrial Fibrillation. | ||
| Hybrid (Convergent) Ablation Procedures | Device | AtriCure's Hybrid (Convergent) Ablation Devices used for the management of Atrial Fibrillation. | ||
| AtriCure Hybrid Totally Thoracoscopic Ablation Procedures | Device | AtriCure's Hybrid Totally Thoracoscopic Surgical Ablation Devices used for the management of Atrial Fibrillation. | ||
| AtriCure LAA Exclusion Procedures | Device | AtriCure's LAA Exclusion Devices used to exclude the Left Atrial Appendage for the management of Atrial Fibrillation. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's AF burden 6-month after receiving the ablation procedure | Collect patient data on Atrial Fibrillation burden after the ablation procedure as documented by long term event monitoring or identified during the exam after a six-month recovery period. | 6 months |
| Adverse events of the ablation procedure as atrial fibrillation management | Collect data on adverse events occurred during and post operation to assess the safety of the ablation procedure. | 1 year |
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| Measure | Description | Time Frame |
|---|---|---|
| Medications | On/Off AAD or Anticoagulant post procedure | 12 months |
Inclusion Criteria:
Exclusion Criteria:
1. Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol.
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The TRAC-AF registry eligibility is open to sites and physicians performing open concomitant or hybrid ablation therapy procedures as treatments for patients diagnosed with paroxysmal, persistent or long-standing persistent atrial fibrillation using at least one of AtriCure's ablation devices. Subjects must have been scheduled to undergo or have undergone the cardiac ablation treatment and must meet all eligibility criteria in order for their treatment and results to be considered for this registry.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jarrod Goodarz, BA | Contact | 609-331-6621 | jgoodarz@atricure.com | |
| Joey Stimler, DPT | Contact | 513-926-3875 | jstimler@atricure.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville Hospital | Recruiting | Huntsville | Alabama | 35801 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| St. Bernards Medical Center | Recruiting | Jonesboro | Arkansas | 72401 | United States |
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| CHI St. Vincent Heart Institute | Recruiting | Little Rock | Arkansas | 72205 | United States |
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| Loma Linda University Medical Center | Recruiting | Loma Linda | California | 92354 | United States |
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| Adventist Heart Institute (St. Helena Hospital) | Recruiting | St. Helena | California | 94574 | United States |
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| Valley View Hospital | Recruiting | Glenwood Springs | Colorado | 81601 | United States |
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| MedStar Washington Hospital | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| Delray Medical Center | Recruiting | Delray Beach | Florida | 33484 | United States |
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| University of Florida | Recruiting | Gainesville | Florida | 32608 | United States |
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| Orlando Health Heart & Vascular Institute | Recruiting | Orlando | Florida | 32806 | United States |
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| St. Joseph's Hospital (BayCare) | Recruiting | Tampa | Florida | 33607 | United States |
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| Franciscan Health | Recruiting | Indianapolis | Indiana | 46237 | United States |
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| Kansas City Heart Rhythm Institute | Recruiting | Overland Park | Kansas | 66211 | United States |
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| Norton Heart & Vascular Institute | Recruiting | Louisville | Kentucky | 40222 | United States |
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| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Corewell Health | Recruiting | Grand Rapids | Michigan | 49503 | United States |
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| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
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| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
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| Maimonides Health Heart & Vascular Institute | Recruiting | Brooklyn | New York | 11219 | United States |
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| Vassar Brothers Medical Center | Recruiting | Poughkeepsie | New York | 12601 | United States |
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| Atrium Health Wake Forest Baptist | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| UH Cleveland Harrington Heart & Vascular Institute | Recruiting | Cleveland | Ohio | 44106 | United States |
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| Jackson Madison County General Hospital | Recruiting | Jackson | Tennessee | 38301 | United States |
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| Centennial Medical Center | Recruiting | Nashville | Tennessee | 37203 | United States |
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| Michael E. DeBakey VAMC - Houston | Recruiting | Houston | Texas | 77030 | United States |
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| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| Medical University of Vienna | Recruiting | Vienna | Austria |
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| Nova Scotia Health Authority | Recruiting | Halifax | Nova Scotia | B3H3A7 | Canada |
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| Waterloo Regional Health Network | Recruiting | Kitchener | Ontario | N2M1B2 | Canada |
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| 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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