AtriCure Minimally Invasive Surgical Ablation for Atrial Fibrillation/RESTORE IIB

Study Overview
=================
Brief Summary
-----------------
Feasibility study arm to evaluate the safety of adding the left atrial linear connecting lesions of the Cox-Maze lesion set to the current RESTORE SR II IDE study procedure of performing pulmonary vein isolation, selected left atrial autonomic ganglionated plexi (GP) ablation, and optional left atrial appendage (LAA) excision/exclusion on a beating heart for patients with permanent or persistent Atrial Fibrillation (AF).

Official Title
-----------------
Thoracoscopically-Assisted Epicardial Bilateral Pulmonary Vein Isolations Using the AtriCure Bipolar System and Exclusion of the Left Atrial Appendage for the Treatment of Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: AtriCure Bipolar System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient between 18 and 80 years of age Patient with documented symptomatic persistent or permanent AF and failure or intolerance of one or more Class I or Class III antiarrhythmic drugs. Persistent AF: AF that is not self-terminating or is terminated electrically or pharmacologically. Longstanding AF: Persistent AF of 12 months (or longer) duration. Permanent AF: Longstanding AF in which electrical or pharmacological cardioversion has failed or has not been attempted. Patient is willing and able to provide written informed consent. Patient has a life expectancy of at least 2 years. Patient is willing and able to attend the scheduled follow-up visits. Exclusion Criteria: Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months. Patients who refuse, but have not failed and can tolerate anti-arrhythmic medications Myocardial infarction within 8 weeks. Prior cardiac surgery. Patient requires cardiac surgery for treatment other than for AF. Class IV NYHA heart failure symptoms, unless due to uncontrolled AF Cerebrovascular accident within previous 6 months Known carotid artery stenosis greater than 80% Evidence of significant active infection Patient unable to undergo TEE Pregnant woman Patient requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia Presence of thrombus in the left atrium Co-morbid condition that in the opinion of the investigator poses undue risk of general anesthesia or port access cardiac surgery Patient is enrolled in another cardiac clinical trial Left ventricular ejection fraction < 30% Left atrial transverse diameter >6.0 Patient has undergone previous thoracic targeted radiation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of performing the operation by demonstrating the ability to consistently isolate the left and right pulmonary veins and to confirm conduction block across the roof, anterior and LAA linear lesions. |  |  | 
| The primary safety endpoint will be determined by assessing the rate of serious adverse events. |  |  |