Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Inclusion criteria

• Subjects ≥ 18 years of age
• Documentation of any of the following clinical criteria:

• CHA2DS2-VASc ≥ 4 with age ≥ 65
• CHA2DS2-VASc ≥ 4 with significant left atrium enlargement or elevated NT-proBNP
• CHA2DS2-VASc = 3 with age ≥ 75
• CHA2DS2-VASc = 3 with significant left atrium enlargement or elevated NT-proBNP
• CHA2DS2-VASc score = 2 with age ≥ 65 and significant left atrium enlargement or elevated NT-proBNP

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

o 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