AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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ABLATE Persistent is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating persistent atrial fibrillation during concomitant on-pump cardiac surgery.

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: AtriCure Bipolar System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is greater than or equal to 18 years of age Subject has history of persistent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following: Mitral valve repair or replacement Aortic valve repair or replacement Tricuspid valve repair or replacement Coronary Artery Bypass procedures Subject's Left Ventricular Ejection Fraction ≥ 30% Subject is able and willing to provide written informed consent and comply with study requirements Subject has life expectancy of at least 1 year Exclusion Criteria: Patients with longstanding and continuous AF in which cardioversion has failed or has not been attempted Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical Maze procedure Wolff-Parkinson-White syndrome Prior cardiac surgery (Redo) Class IV NYHA heart failure symptoms Prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit Documented MI within 6 weeks prior to study enrollment Need for emergent cardiac surgery (i.e. cardiogenic shock) Known carotid artery stenosis greater than 80% LA size greater than or equal to 8 cm Current diagnosis of active systemic infection Severe peripheral arterial occlusive disease defined as claudication with minimal exertion Pregnancy or desire to get pregnant within 12-months of the study enrollment Preoperative need for an intra-aortic balloon pump or intravenous inotropes Renal failure requiring dialysis or hepatic failure Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: AtriCure Bipolar System|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy endpoint for this study is the percent of patients free from AF and off Class I and III antiarrhythmic drugs at 9 months. |  |  | 
| The primary safety endpoint is the composite acute major adverse event rate, within 30 days post-procedure or hospital discharge |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary efficacy endpoint for this study is the percent of patients free from AF, independent of antiarrhythmic drug status at 9 months |  |  | 
| The secondary safety endpoint is the composite 9-month post-procedure major adverse event rate. |  |  |