Study in Atrial Fibrillation (AF) Patients at High Risk of Stroke

Inclusion Criteria:

• Written informed consent from the patient, or legally authorized representative,must be obtained before any assessment is performed

• Patients with diagnosed AF or atrial flutter(documented on an electrocardiogram ormonitor recording)

• CHA2DS2-VASc score ≥2 excluding female as a factor

• Judged by the investigator to be at increased risk of bleeding because of at least 1of the following:

• Age ≥70on the day of informed consent

• Reduced renal function (creatinine clearance <30mL/min by Cockcroft-Gault)

• Chronic use of NSAIDs or antiplatelet agents

• Any other condition associated with increased risk such as a prior history ofmajor or clinically relevant nonmajor bleeding, increased fall risk, or frailty

• Patients who are not treated with oral anticoagulants (only applies to the initialfeasibility cohort)

Exclusion Criteria:

• Mechanical heart valve or valve disease that is expected to require valvereplacement intervention (surgical or invasive) during the course of the registrystudy

• AF due to a reversible cause (eg, cardiac surgery, pulmonary embolism, untreatedhyperthyroidism, ethanol use)

• Clinical unstable or active endocarditis or endovascular infection

• Patients with a medical condition other than AF for which chronic use of an oralanticoagulant is indicated

• History of left atrial appendage closure or removal

• Life expectancy <1 year at the time of enrollment as assessed by the investigator

• Any medical or psychiatric condition which in the judgment of the Investigator maypreclude patients from complying with study requirements for the duration of thestudy