Safety and Efficacy of SYM-SV/DS-002 in Patients With Severe Aortic Stenosis
Safety and Efficacy of SYM-SV/DS-002 in Patients With Severe Aortic Stenosis
Safety and Efficacy of SYM-SV/DS-002 in Patients with Severe Aortic Stenosis
To evaluate the safety and efficacy of Transfemoral Transcatheter Aortic Valve Implantation
 using SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System in patients
 presenting with symptomatic severe aortic stenosis and with difficulty to safely undergo
 conventional surgical aortic valve replacement (AVR)
Inclusion Criteria:

 1. At least one cardiologist and one cardiac surgeon agree that it is difficult for the
 patient to receive a surgical procedure due to medical factors such that the subject
 has various comorbidities and he/she is more likely to die or suffer from severe
 diseases than to have significant improvements by a surgical procedure.

 2. Subject has senile degenerative aortic valve stenosis with:

 -  mean gradient > 40 mmHg, or maximum jet velocity greater than 4.0 m/sec by either
 resting or dobutamine stress echocardiogram, or simultaneous pressure recordings
 at cardiac catheterization

 -  AND an initial aortic valve area of ≤ 0.8 cm2 (or aortic valve area index ≤ 0.5
 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac
 catheterization

 3. Subject is symptomatic from his/her aortic valve stenosis (AS), as demonstrated by New
 York Heart Association (NYHA) Functional Class II or greater.

 4. The subject has been informed of the nature of this trial, agrees to its provisions
 and has provided written informed consent as approved by the IRB of the respective
 clinical site.

 5. The subject or the subject's legal representative agrees to visit the site where
 he/she receives index procedure for all required post-procedure follow-ups.

 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