BoxX-NoAF Clinical Trial

Prior treatment

• 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)
• Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial

Other illness

• 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
• NYHA Class IV heart failure symptoms
• 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
• Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial.
• Known severe symptomatic carotid disease

Other

• Presence of a permanent pacemaker
• Infiltrative cardiomyopathies (i.e. amyloidosis)
• Active endocarditis
• Preoperative need for an intra-aortic ballon pump or intravenous inotropes
• Other comorbidities that in the Investigator's opinion make the subject unsuitable candidate to complete the protocol required intervention or visits
• Pregnancy

• Planned and clinically indicated for cardiac surgical procedure requiring cardiac bypass and opening of the pericardium
• Age ≥ 65 years and CHA2DS2-VASc ≥ 3