Abbott Medical - VERITAS Study

Inclusion Criteria:

1. Paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvularAF and has not been diagnosed with rheumatic mitral valve disease

2. CHA2DS2-VASc score of ≥2 for males or ≥3 for females

3. Has an appropriate rationale to seek a non-pharmacologic alternative to oralanticoagulation

4. Subject is eligible to stop anticoagulation if the LAA is sealed based on theimplanting physician's opinion

5. Subject is able to comply with the protocol defined pharmacologic regimen followingAmulet 2 device implant (as described in Section 6.5)

6. Subject is able to understand and willing to provide written informed consent toparticipate in the clinical investigation

7. Subject is able and willing to return for required follow-up visits and protocolrequired clinical investigation activities

8. 18 years of age or older, or the age of legal consent

Exclusion Criteria:

1. Required to take P2Y12 platelet inhibitor beyond 6 months when Amulet 2 LAA Occluderimplant procedure would occur

2. Is considered at high risk for general anesthesia in the opinion of the Investigatoror based on past adverse reaction(s) requiring medical intervention or whichresulted in prolongation of hospital stay

3. Atrial septal defect or patent foramen ovale repair or occluder

4. Implanted with a mechanical valve prosthesis

5. Subject anatomy will not accommodate or is contraindicated for transesophagealechocardiography probe use (e.g., presence of esophageal varices, esophagealstricture, or history of esophageal cancer), or subject has experienced adverseevents related to transesophageal echocardiography acquisition or has refusedtransesophageal echocardiography acquisition in the past

6. Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior towhen Amulet 2 device implant procedure would occur (any intervention or surgery thatutilized anesthesia, anesthetic, or sedation)

7. Underwent catheter ablation for AF or atrial flutter within 60 days prior to whenAmulet 2 device implant procedure would occur

8. Inpatient hospitalization due to clinical event or other sequelae within the past 7days (i.e., not related to planned clinical study procedure or assessments)

9. Subject is planning any cardiac or non-cardiac intervention or surgery within 60days after when Amulet 2 device implant procedure would occur (any intervention orsurgery that utilized anesthesia, anesthetic, or sedation), except for study relatedactivities

10. Inferior vena cava filter present

11. Left ventricular ejection fraction ≤30% (per most recent assessment)

12. Experienced stroke or transient ischemic attack within 90 days prior to when Amulet 2 device implant procedure would occur

13. Experienced myocardial infarction (with or without intervention) within 90 daysprior to when Amulet 2 device implant procedure would occur

14. New York Heart Association (NYHA) Class IV Congestive Heart Failure

15. Known symptomatic carotid disease (defined as > 50% lumen diameter narrowing on CTA,MRA, or TCD with symptoms of ipsilateral transient or visual TIA evidenced byamaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject hasa history of carotid stent or endarterectomy the subject is eligible if there is < 50% lumen diameter narrowing

16. Underwent prior attempted endocardial, epicardial, or surgical LAA closure orocclusion, defined as deployment of a device or surgical procedure whethersuccessful or unsuccessful

17. Reversible cause of AF (i.e., secondary to thyroid disorders, acute alcoholintoxication, trauma, recent major surgical procedures)

18. History of idiopathic or recurrent venous thromboembolism within the past 5 years

19. Thrombocytopenia (defined as < 50,000 platelets per microliter (<50 x 109/L) oranemia (defined as hemoglobin < 10 g/dL) requiring transfusions

20. Known hypersensitivity to any portion of the device material or individualcomponents of the Amulet 2 device (e.g., nickel allergy)

21. Actively enrolled in, or plans to enroll in, a concurrent clinical investigation inwhich the active treatment arm may confound the results of the VERITAS Study. Eachinstance must be brought to the attention of the Sponsor to determine eligibility.

22. Is pregnant or breastfeeding, or pregnancy is planned during the course of theinvestigation

23. Active endocarditis or other infection producing bacteremia

24. Transient case of AF (i.e., never previously detected, provoked/induced by surgicalor catheter manipulations, etc.)

25. Severe renal failure (estimated glomerular filtration rate <30 ml/min/1.73m2) or onchronic dialysis

26. Life expectancy is less than 2 years in the opinion of the Investigator

27. Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the Investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow up requirements, or impact the scientific soundness of the clinicalinvestigation results.

Anatomical Exclusion Criteria:

1. Intracardiac thrombus

2. Existing circumferential pericardial effusion >2 mm

3. Mitral valve stenosis, defined as a mitral valve area of <1.5 cm2

4. Inter-atrial communication (PFO/ASD with right to left shunt, if TEE performed) withan atrial septal aneurysm (excursion >15 mm or length ≥15 mm; excursion defined asmaximal protrusion of the atrial septal aneurysm beyond the plane of the atrialseptum) or large shunt (i.e., during Valsalva maneuver ≥20 bubbles of right-to-leftshunt within 3 cardiac cycles after contrast media enters the right atrium, if TEEperformed)

5. Complex atheroma of the descending aorta and/or aortic arch, defined as plaque >4 mmin thickness, plaque ulceration, and/or mobile lesions

6. Cardiac tumor

7. LAA anatomy that cannot accommodate the Amulet 2 device, as per manufacturer's IFU (i.e., the LAA size must be within the sizing chart of the Amulet 2 device)

8. Placement of the device would damage or interfere with the function of anyintracardiac or intravascular structure