Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study

Exclusion Criteria

• •1. Other identifiable causes of stroke, including but not limited to aortic arch plaques (protruding \>4 mm into the lumen), large artery atherosclerotic disease proximal to the territory of the index stroke, an established cardioembolic source, small-vessel occlusive disease, or arterial dissection, presence of left atrial appendage thrombus.
• •2. Other arteriopathy of the intracranial or extracranial vessels with \>50% stenosis proximal to the territory of the index stroke.
• •3. Intracardiac thrombus or tumor.
• •4. Myocardial Infarction (MI) or unstable angina within the previous 180 days.
• •5. Life expectancy \< 2 years.
• •6. Left ventricular aneurysm or akinesis.
• •7. Moderate to severe mitral valve stenosis or severe mitral regurgitation.
• •8. Aortic valve stenosis (mean gradient \>20 mmHg) or severe regurgitation.
• •9. Active endocarditis or other infection that may preclude implantation of the investigational device.
• •10. Any valve vegetation or Lambl's excrescence of any left-sided valve.
• •11. Left ventricular dilated cardiomyopathy with LVEF \<35%.
• •12. Another source of right-to-left shunts identified at baseline, including an atrial septal defect and/or fenestrated septum and pulmonary arteriovenous malformation.
• •13. History of atrial tachycardia, atrial fibrillation or flutter, AV block, or ventricular arrhythmia requiring antiarrhythmic medication, pacemaker, or AICD.
• •14. Severe renal failure ( Stage 4 CKD, eGFR \<30) or patient requiring dialysis.
• •15. Severe liver disease (e.g., documented cirrhosis or active hepatitis).
• •16. Severe lung insufficiency (e.g., need for supplemental oxygen or chronic steroid medications).
• •17. Uncontrolled hypertension, defined as sustained elevated blood pressure \>140/90 mm Hg.
• •18. Severe pulmonary artery hypertension, defined as pulmonary systolic pressure of \>50mmHg.
• •19. Uncontrolled hyperglycemia, defined as HbA1c value \>8% (IFCC: \>64 mmol/mol).
• •20. Increased bleeding risk such as severe liver failure, active peptic ulcer, proliferative diabetic retinopathy, history of severe bleeding (e.g.: gastrointestinal bleeding, macroscopic hematuria, intraocular bleeding, intracranial or cerebral hemorrhage), or other history of bleeding or coagulopathy.
• •21. Known hypercoagulable state that would require full anticoagulation. Minimum testing to include lupus anticoagulant, anticardiolipin antibodies, beta-2-glycoprotein, homocysteine.
• •22. Subjects contraindicated for aspirin or clopidogrel.
• •23. Subjects not able to discontinue anticoagulation for indications other than then index stroke.
• •24. Any disorder in the investigator's opinion that could interfere with compliance of safety evaluation or require premature discontinuation of antiplatelet regime post-implantation, as well as any severe concurrent illness that would limit life expectancy (e.g., malignancies).
• •25. Currently an active subject in an investigational drug or device study that could confound the results of this study.
• •26. Any significant valve dysfunction that contraindicates PFO closure or increased pulmonary vascular resistance/severe pulmonary hypertension.
• •27. Contraindication for transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE).
• •28. Any prior percutaneous cardiovascular intervention for AF ablation.