Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology

Inclusion Criteria:

1. The subject is of legal age to participate in the study per the laws of their
respective geography.

2. The subject has documented paroxysmal, persistent, permanent or long-term/longstanding
persistent non-valvular atrial fibrillation (i.e., the subject has not been diagnosed
with rheumatic mitral valvular heart disease).

3. The subject is eligible for the defined protocol pharmacologic regimen of warfarin and
antiplatelet therapy following WATCHMAN FLX Device implant.

4. The subject is eligible to come off warfarin therapy if the LAA is sealed (i.e., the
subject has no other conditions that would require long-term warfarin therapy
suggested by current standard medical practice).

5. The subject has a calculated CHADS2 score of 2 or greater or a CHA2DS2-VASc score of 3
or greater.

6. The subject is able to understand and willing to provide written informed consent to
participate in the trial.

7. The subject is able and willing to return for required follow-up visits and
examinations.

Exclusion Criteria:

1. Subjects who are currently enrolled in another investigational study or registry that
would directly interfere with the current study, except when the subject is
participating in a mandatory governmental registry, or a purely observational registry
with no associated treatments. Each instance must be brought to the attention of the
sponsor to determine eligibility, regardless of type of co-enrollment being proposed.

2. The subject requires long-term anticoagulation therapy for reasons other than
AF-related stroke risk reduction, for example due to an underlying hypercoaguable
state (i.e., even if the device is implanted, the subjects would not be eligible to
discontinue warfarin due to other medical conditions requiring chronic warfarin
therapy).

3. The subject is contraindicated for warfarin therapy.

4. The subject is contraindicated or allergic to aspirin.

5. Subject is contraindicated for clopidogrel (P2Y12 inhibitor for Japan).

6. The subject is indicated for clopidogrel (P2Y12 inhibitor for Japan) therapy or has
taken clopidogrel (P2Y12 inhibitor for Japan) within 7 days prior to the WATCHMAN FLX
Device implant.

7. The subject had or is planning to have any cardiac or non-cardiac invasive or surgical
procedure within 30 days prior to or 60 days after the WATCHMAN FLX Device implant
(including, but not limited to: cardioversion, coronary angiogram with or without
percutaneous coronary intervention (PCI), cardiac ablation, cataract surgery,
endoscopy, etc.).

8. The subject had a prior stroke (of any cause, whether ischemic or hemorrhagic) or
transient ischemic attack (TIA) within the 90 days prior to enrollment.

9. The subject has had a myocardial infarction (MI) documented in the clinical record as
either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or
without intervention, within 90 days prior to enrollment.

10. The subject has a history of atrial septal repair or has an ASD/PFO device.

11. The subject has an implanted mechanical valve prosthesis in any position.

12. The subject currently or has had any documented history of, New York Heart Association
Class IV Congestive Heart Failure.

13. The subject is of childbearing potential and is, or plans to become pregnant during
the time of the study (method of assessment upon study physician's discretion).