Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Prior treatment

• Prior procedure involving opening the pericardium or entering the pericardial space
• 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
  • o Partial sternotomies will be allowed.
• Patients whose planned procedure is a heart transplant or implantation of any ventricular assist devices
• 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
• 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

• Clinically significant atrial fibrillation or atrial flutter:
  • Anytime in the past and
  • Documented by an electrocardiographic recording and
  • Episode lasting 6 minutes or longer1\*
• Active endocarditis
• Other comorbidities that in the investigator's opinion make the subject unsuitable candidate to complete the protocol required visits.
• Pregnancy

• 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