Safety and Efficacy of SYM-SV/DS-002 in Patients With Severe Aortic Stenosis

Exclusion Criteria

• •1. Evidence of an acute myocardial infarction ≤ 30 days (The procedure day is counted as day 0.) before the implant procedure
• •2. Any percutaneous coronary or peripheral interventional procedures, including placements of bare metal stents are performed within 30 days prior to the implant procedure, or any drug eluting stents are placed within 6 months (One month is counted as 30 days.) prior to the implant procedure
• •3. Untreated clinically significant coronary artery disease (CAD) requiring revascularization
• •4. Blood dyscrasias as defined:
• •leukopenia (WBC \< 1,000/mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy
• •5. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
• •6. Need for emergency surgery for any reason
• •7. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20% as measured by resting echocardiogram
• •8. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to the implant procedure (except mild TIA related to aortic stenosis)
• •9. End stage renal disease requiring chronic dialysis or serum creatinine \> 3.0 mg/dL
• •10. Active Gastrointestinal (GI) bleeding within 3 months prior to the implant procedure
• •11. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:
• •* Aspirin
• •* Heparin (HIT/HITTS)
• •* Nitinol (titanium or nickel)
• •* P2Y12 inhibitors (such as Ticlopidine etc.)
• •* Contrast media
• •12. Ongoing sepsis, including active endocarditis
• •13. Subject refuses a blood transfusion
• •14. Life expectancy \< 12 months due to associated non-cardiac comorbid conditions
• •15. Other medical, social, or psychological conditions that in the opinion of a principal investigator or sub-investigator precludes the subject from appropriate consent
• •16. Severe dementia (unable to provide informed consent for the treatment/procedure, unable to live an independent life outside of a chronic care facility, or expected to be fundamentally unable to undergo rehabilitation after the procedure, or unable to come to the site for follow-up visits)
• •17. Currently participating in other trials of investigational drugs or other investigational devices
• •18. Native aortic annulus size \< 21 mm or \> 27 mm per the baseline diagnostic imaging
• •19. Pre-existing prosthetic heart valve and / or prosthetic ring in any position
• •20. Mixed aortic valve disease (aortic stenosis and predominant aortic regurgitation (3-4+))
• •21. Moderate to severe (3-4+) or severe (4+) mitral regurgitation or severe (4+) tricuspid regurgitation
• •22. Moderate to severe mitral stenosis
• •23. Hypertrophic obstructive cardiomyopathy
• •24. New or untreated echocardiographic evidence of intracardiac mass, thrombus or vegetation
• •25. Congenital bicuspid or unicuspid valve verified by echocardiograph
• •26. Extreme eccentric calcification of the native aortic valve
• •27. Transesophageal echocardiogram (TEE) is contraindicated.
• •28. Scheduled surgical or percutaneous procedure to be performed prior to 1-month visit post-implant procedure
• •29. Hepatic failure (Child C or more)
• •30. Aortic or peripheral condition NOT appropriate for transfemoral implant due to the size, disease and degree of calcification or tortuosity of the aorta or ilio-femoral arteries
• •31. Thoracic or abdominal aortic aneurysm
• •32. Woman who is pregnant, breastfeeding or willing to become pregnant