Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  18 and up

Participation Criteria

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