Stroke Feasibility Study

Inclusion criteria

• Patient is ≥ 18 years and ≤ 80 years of age.
• Patient has electrocardiographically confirmed non-valvular atrial fibrillation (paroxysmal, persistent, or longstanding persistent AF).
• CHADS2 or CHA2DS2VASc score ≥2.
• Patient has medical contraindication to long term anticoagulant therapy (OAC), defined as one or more of the following:

• history of intracranial bleeding (e.g. due to amyloid angiopathy or other condition) which renders patient unsafe for OAC;
• history of gastrointestinal, genitourinary, or respiratory tract bleeding due to permanent condition which renders patient unsafe for OAC;
• HAS-BLED Score ≥ 3.
• Patient is considered an acceptable surgical candidate, including use of general anesthesia.
• Female patients must be of non-child bearing potential, or have a negative pregnancy test within 7 days prior to index procedure.

Exclusion criteria

• Stroke within 30 days, or TIA within 3 days, respectively, prior to index procedure.
• Documented medical history of any penetrating trauma to thorax, or blunt trauma to thorax which resulted in a left pneumothorax or left hemothorax.
• Myocardial infarction within 60 days prior to index procedure.
• NYHA Class IV heart failure.
• Ejection fraction < 40% (based on baseline transthoracic echocardiography (TTE)).
• Prior attempted obliteration of left atrial appendage (percutaneous or open cardiac surgery).
• Previous catheter ablation with perforation or complication.
• Prior open cardiac surgery, or percutaneous coronary intervention with associated unintended cardiac perforation, or pericardial adhesions are suspected.
• History of pericarditis or pericardiocentesis.
• Active infection, septicemia, or fever of unknown origin.
• Concomitant elective surgical procedure (in addition to AtriClip placement) at the time of index procedure.
• Planned atrial arrhythmia ablation procedure within six months following index procedure.
• Underlying structural heart disease requiring planned surgical treatment within six months following the index procedure.
• Cardiac or thoracic surgical procedure within the thirty days prior to index procedure.
• Anticoagulation therapy for other medical condition (i.e. deep vein thrombosis) is required.
• Patient unable to discontinue thienopyridines (e.g. clopidogrel) or non-ASA antiplatelet agents 4 days pre-operatively and abstain for at least 2 days post-operatively.
• Renal Failure as defined by creatinine > 2.0 mg/dl (> 152.5 umol/L) and/or need for dialysis.
• Known carotid artery diameter stenosis greater than 80%.
• Patient has symptomatic or high-grade carotid disease (>70% bilaterally).
• Patient unable or unwilling to undergo transesophageal echocardiography (TEE).
• Presence of thrombus in the left atrium or LAA, as determined by baseline TTE or Computed Tomography Angiogram (CTA).
• Documented history of thrombophilic disorder, with diagnosis established via previous objective testing (e.g. familial screening for thrombophilia).
• Moderate to Severe Chronic Obstructive Pulmonary Disease (FEV1 or VC<70% predicted) or intolerant of single lung ventilation.
• History of Hypercoagulopathy
• Body Mass Index (BMI) > 35.
• Other medical illness or comorbidity that may cause non-compliance with the protocol, confound data interpretation (e.g. severe dementia), or limited life expectancy (i.e. < 3 months).
• Enrolled in another investigational device or drug study at the time of enrollment and during the course of the study.
• Psychiatric disorder which in the judgment of the investigator could interfere with informed consent, completion of tests, therapy, or follow-up.
• Patient is pregnant or intends to become pregnant within 6 months post-index procedure.

Intraoperative Exclusion Criteria

• Left atrial appendage width < 29mm or > 50mm, based on TEE imaging.
• Presence of thrombus in the left atrium or LAA based on TEE imaging.