WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2

The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical
trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage
(LAA) Occlusion System. Subjects will be randomized in a 1:1 ratio to the Treatment Arm
(Coherex WaveCrest LAA occlusion system) or the Control Arm (Boston Scientific's Watchman LAA
occlusion system). The trial is designed to demonstrate that safety and effectiveness of the
WaveCrest device are non-inferior to the Watchman device.

Inclusion Criteria:

1. Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial
fibrillation

2. At least 18 years of age

3. Calculated CHADS2 score ≥ 2 or CHA2DS2-VASc score ≥ 3

4. Indication for warfarin therapy with an appropriate rationale to seek a
non-pharmacologic alternative to chronic oral anticoagulation

5. Willing and able to comply with post-implant anticoagulation and antiplatelet regimen

6. Willing to participate in the required follow-up visits and tests

7. Subject has been informed of the nature of the trial, agrees to its provisions and has
provided written informed consent as approved by the IRB/EC at the site

Exclusion Criteria:

1. Atrial fibrillation (AF) due to a reversible cause (e.g. thyrotoxicosis or
postoperative)

2. Known contraindication and/or allergy to warfarin, nickel, aspirin, intravenous
contrast or P2Y12 inhibitors (clopidogrel, ticagrelor, and prasugrel), which cannot be
adequately pre-medicated or desensitized

3. Conditions other than AF requiring long-term anticoagulation therapy

4. Contraindications for percutaneous catheterization procedures

5. Prior surgical LAA occlusion/exclusion or implanted with LAA occlusion device, or any
prior attempt of such procedures

6. Prior percutaneous or surgical closure of a patent foramen ovale or atrial septal
defect

7. Inability or unwillingness to take oral anticoagulation for 45 days post-procedure

8. New York Heart Association (NYHA) Class IV heart failure

9. Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral
valve intervention, or any mechanical valve implant

10. History of symptomatic carotid, intervertebral, or intracranial artery occlusion or
stenosis without revascularization with the exception of known occlusion without
symptoms > 6 months

11. Modified Rankin Scale (mRS) score ≥ 4

12. Chronic resting heart rate ≥ 110 bpm

13. Congenital cardiac anomalies requiring cardiac surgery or interventional repair

14. Stroke or transient ischemic attack (confirmed by Neurologist) within 60 days prior to
enrollment

15. Myocardial infarction within 60 days prior to enrollment

16. Sepsis or any infection requiring oral antibiotic therapy within 14 days or
intravenous antibiotic therapy within 30 days prior to enrollment

17. Surgical or interventional cardiovascular and non-cardiovascular procedure including
cardioversion within 30 days prior to enrollment or AF ablation within 60 days prior
to enrollment or any planned general surgery or interventional procedure within 90
days after enrollment or any planned cardiac surgery.

18. On renal replacement therapy, serum creatinine > 3.0 mg/dl (265 μmol/L) or calculated
creatinine clearance < 25 ml/minute

19. Thrombocytopenia (<60,000 platelets/mm3), leucopenia (white blood cell count < 3,000
cells/mm³), or anemia (hemoglobin concentration < 10 grams/deciliter) based on blood
work done within 30 days prior to enrollment

20. Any medical disorder or psychiatric illness that would interfere with successful
completion of the trial

21. Currently participating in an investigational drug trial or another device trial that
has not completed the primary endpoint (trials requiring extended follow-up for
products that are commercially available are not considered investigational trials).
Concurrent enrollment in the ACC LAAO Registry is permitted.

22. Subject belongs to a vulnerable population (see definition in Appendix I: Acronyms and
Definitions)

23. Any condition that would reduce life expectancy to less than 2 years

24. Women of childbearing potential who are, or plan to become pregnant during the time of
the trial (method of assessment per physician discretion)

Echocardiographic Exclusion Criteria

1. Left ventricular ejection fraction < 30%

2. Mitral valve stenosis defined as valve area < 1.5cm2, mean gradient > 6mmHg, or any
valve deformity consistent with rheumatic valvular disease

3. Aortic valve stenosis defined as valve area ≤1.0cm2 or mean gradient >30mmHg

4. Circumferential pericardial effusion > 10mm or symptomatic pericardial effusion

5. Evidence of intracardiac thrombus

6. Cardiac tumor or myxoma

7. Atrial septal defect that warrants closure

8. Complex atheroma in the ascending aorta or aortic arch as evidenced by mobile plaque

9. Left Atrial Appendage size and shape are unsuitable for closure with a WaveCrest or
Watchman device