Clinical Trials

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.