BoxX-NoAF Clinical Trial

Exclusion Criteria

• •Documented history of atrial fibrillation or atrial flutter anytime prior to the cardiac surgery
• •Prior procedure involving opening the pericardium or entering the pericardial space
• •Patients undergoing off-pump surgery
• •Prior LAA occlusion, exclusion, or removal (surgical or percutaneous)
• •Presence of a permanent pacemaker
• •Infiltrative cardiomyopathies (i.e. amyloidosis)
• •Planned cardiac surgical procedure using non-sternotomy approaches
• •Patients whose planned procedure is a heart transplant or implantation of any long-term ventricular assist devices
• •Presence of ventricular arrhythmia
• •Active endocarditis
• •NYHA Class IV heart failure symptoms
• •Preoperative need for an intra-aortic ballon pump or intravenous inotropes
• •Active systemic infection at the time of cardiac surgery requiring antibiotics
• •Known allergy to Nitinol or nickel sensitivity
• •Known medical condition with expected survival of less than 1 year
• •Other comorbidities that in the Investigator's opinion make the subject unsuitable candidate to complete the protocol required intervention or visits
• •Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial
• •Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial.
• •Pregnancy
• •Known severe symptomatic carotid disease