Clinical Trials

Exclusion Criteria:

• Clinically significant atrial fibrillation or atrial flutter:
• Anytime in the past and
• Documented by an electrocardiographic recording and
• Episode lasting 6 minutes or longer1*
• Prior procedure involving opening the pericardium or entering the pericardial space
• Prior LAA occlusion, exclusion, or removal (surgical or percutaneous)
• Planned cardiac surgical procedure using non-sternotomy approaches
• Partial sternotomies will be allowed.
• Patients whose planned procedure is a heart transplant or implantation of any ventricular assist devices
• Active endocarditis
• Active systemic infection at the time of cardiac surgery requiring antibiotics, including known SARS-CoV2 infections regardless of symptoms
• 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 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