AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation

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

Official Title
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AtriCure Synergy Bipolar RF Energy Lesions for Permanent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial 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 permanent 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 Atrial Septal Defect Repair Patent Foramen Ovale closure 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: Stand alone AF without indication(s) for concomitant CABG, valve surgery, ASD repair, or PFO closure 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 8cm 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AtriCure Bipolar System<br>The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure. | Device: AtriCure Bipolar System<br>* Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months. |  | 6 Months Post Procedure | 
| Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge | Major Adverse Events consist of Death within 30 days or beyond 30 days if considered device related, Excessive Bleeding, Stroke, TIA or MI. A clinic visist was performed at 30 days to fully assess the patient for adverse events. | 30 days Post Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients Free From AF, Independent of Antiarrhythmic Drug Status as Determined by Holter Monitoring at 6 Months. |  | 6 Months Post Procedure | 
| Composite 6-month Post-procedure Major Adverse Event Rate. |  | 6 Months Post Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, af, ablation, arrhythmia, racing heart, afib, surgical ablation