Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach

Prior treatment

• Undergone prior cardiothoracic surgery, previous thorax trauma which resulted in a pneumothorax or hemothorax.
• Sleep apnea, home oxygen therapy, moderate to severe COPD, (FEV1/FVC \< 70% predicted) or patient is considered intolerant to single lung ventilation.
• Documented history of previous catheter ablation with perforation, history of pericarditis, pericardial effusion, or tamponade.
• CAD requiring intervention (either surgical, i.e. CABG, or catheter).
• Stroke/cerebrovascular accident (CVA) within previous six months, carotid artery stenosis greater than 80%.
• Documented thromboembolism within the previous six months prior to signing informed consent.
• Currently abusing drugs or alcohol.
• Currently or has participated in a clinical study in the last 3 months prior to signing informed consent.

Other illness

• Refractory hypertension, defined as systolic (\>150 mm Hg) or diastolic (\> 90 mm Hg) blood pressure that remains uncontrolled despite sustained therapy
• History of pulmonary hypertension
• NYHA Class IV heart failure.
• Uncorrected, reversible cause(s) of atrial fibrillation, or is currently being treated for arrhythmias other than atrial fibrillation (AF) or atrial flutter.
• Structural heart disease requiring surgical treatment (i.e. valve disease requiring repair or replacement within 12 months following surgical ablation procedure).
• Blood dyscrasia or clotting disorder (i.e. Idiopathic Thrombocytopenic Purpura \[ITP\] or Thrombotic Thrombocytopenic Purpura \[TTP\]).
• A condition or congenital anomaly which prevents required surgical or catheter access.
• A co-morbid condition that, in the opinion of the investigator, poses undue risk of general anesthesia or port access cardiac surgery.
• A psychological disorder that could interfere with provision of informed consent, completion of tests, therapy, or follow-up.
• A condition that, in the opinion of the investigator, may jeopardize the patient's well-being and/or the soundness of this clinical study.
• Pre-existing esophageal condition that required (or requires) endoscopic therapy or surgical treatment.

Lab values

• Ejection fraction \< 30%

Age

• AF \>10 years.

Other

• Pulmonary vein stenosis in one or more of the pulmonary veins
• EP catheter ablation procedure to treat atrial fibrillation within 3 months
• Measured left atrial diameter \> 5.5 cm
• BMI is \>40
• Thrombus in the left atrium or the left atrial appendage, determined by echocardiography (either at baseline TTE (or equivalent diagnostic test) or intraoperative TEE).
• Contraindication to anticoagulation that in the opinion of the investigator poses undue risk to the patient from participating in the endocardial EP procedure.
• Has the following atrial myxoma, mural thrombus or mural tumor.

• 1\. Symptomatic Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation refractory to a minimum of one Class I or Class III AADs.