Amplatzer Amulet LAAO vs. NOAC

Inclusion Criteria

• •Documented paroxysmal, persistent, or permanent non-valvular AF (documentation must include an electrocardiogram, Holter, or event recorder)
• •At high risk of stroke or systemic embolism, defined as a CHA2DS2-VASc score of ≥ 2 for men and ≥ 3 for women
• •Eligible for long-term NOAC therapy
• •Able to comply with the required NOAC medication regimen if randomized to the Control Group
• •Able to comply with the required medication regimen post-device implant if subject is randomized to the Device Group or subject is a Roll-in
• •Able to understand, and is willing to provide, written informed consent to participate in the trial, prior to any clinical investigation related procedure or assessment
• •18 years of age or older, or the age of legal consent
• •Able and willing to return for required follow-up visits and assessments
• •Has known intracranial atherosclerosis and/or intracranial small vessel disease (defined as 6 points on the Fazekas Scale)
• •Reversible cause of AF (i.e., secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
• •History of idiopathic or recurrent venous thromboembolism
• •LAA is obliterated or surgically ligated
• •Thrombocytopenia (defined as \< 50,000 platelets per microliter (\<50 x 10\^9 /L)or anemia (defined as hemoglobin \< 10 g/dL) requiring transfusions
• •Hypersensitivity to any portion of the device material or individual components of the Amulet LAA occluder device (e.g., nickel allergy)
• •Actively enrolled in, or plans to enroll in, a concurrent clinical study in which the active treatment arm may confound the results of this trial
• •Is pregnant or breastfeeding, or pregnancy is planned during the course of the investigation
• •Active endocarditis or other infection producing bacteremia
• •Transient case of AF (i.e., never previously detected, provoked/induced by surgical or catheter manipulations, etc.)
• •Severe renal failure (estimated glomerular filtration rate \<30 ml/min/1.73m2), but not on dialysis
• •Life expectancy is less than 2 years in the opinion of the Investigator
• •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the Investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow up requirements, or impact the scientific soundness of the clinical investigation results.