Encore PFO Closure Device - The PerFOrm Trial

Exclusion Criteria

• •1. Age \<18 years and age \>60 years
• •2. Greater than 50% lumen diameter stenosis of intracranial or extracranial vessels
• •3. Intracardiac thrombus or tumor
• •4. Acute or recent (within 6 months) myocardial infarction (MI) or unstable angina
• •5. Left ventricular aneurysm or akinesis
• •6. Mitral valve stenosis (mitral valve area less than 1.5cm2) or severe mitral regurgitation
• •7. Aortic valve stenosis (gradient \>40 mmHg) or severe aortic valve regurgitation
• •8. Mitral or aortic valve vegetation or prosthesis
• •9. Left ventricular ejection fraction \<35%
• •10. Other identifiable cause of stroke, including but not limited to aortic arch plaques (protruding \>4 mm into the lumen), large artery atherosclerotic disease, an established cardioembolic source, small-vessel occlusive disease, or arterial dissection
• •11. Evidence of a hypercoagulable disorder requiring anticoagulation therapy; this determination will be based on the evaluation of: anticardiolipin antibody (Ab) of the IgG or IgM type, Lupus anticoagulant, B2-glycoprotein-1 Ab, and fasting plasma homocysteine
• •12. Another source of right-to-left shunts identified at baseline, including an atrial septal defect and/or fenestrated septum
• •13. Any history of atrial fibrillation/atrial flutter (chronic or intermittent)
• •14. Active endocarditis or other untreated infections
• •15. Chronic kidney disease stage 4 or higher or end-stage renal failure requiring dialysis (eGFR less than 30)
• •16. Severe liver disease (ALT 3X ULN) or documented cirrhosis
• •17. Lung disease requiring continuous home oxygen
• •18. Uncontrolled hypertension, defined as sustained elevated blood pressure \>160/90 mm Hg on medication
• •19. Uncontrolled diabetes mellitus, defined as HbA1c greater than 9 (based on most recent test which must have been collected within the last year)
• •20. Anatomical or physiological structures that do not permit TEE
• •21. Anticipated need for treatment of structural cardiac defects other than PFO
• •22. Concomitant cardiac anomalies requiring an operative procedure
• •23. Hemorrhagic diseases (e.g., coagulopathy, tendency to hemolysis)
• •24. Hypersensitivity to contrast medium or nickel
• •25. Contraindication to aspirin or clopidogrel
• •26. The required sheaths cannot be passed through the relevant vessels for access to the PFO
• •27. Vulnerable patient (e.g., incarcerated or cognitively challenged adults); see Section 7.2.1
• •28. Subject is unable or unwilling to provide informed consent
• •29. Subject is unable to comply with the protocol
• •30. Any other clinical reasons for which the patient would not be an appropriate candidate for the study, as determined by the site investigators