ASSESSMENT OF THE ST. JUDE MEDICAL PORTICO* TRANSCATHETER AORTIC VALVE IMPLANT (TAVI) AND THE SJM TAVI TRANSFEMORAL DELIVERY SYSTEM

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

1. Subject has given written study Informed Consent for participation prior to
procedure.
2. Subject is >= 18 years of age or legal age in host country.
3. Subject*s aortic annulus diameter meets the range indicated in the
Instructions for Use as measured by CT conducted within the past 120
days, or echocardiogram (TEE 3D recommended) if medically
contraindicated to CT.
4. Subject has senile degenerative aortic stenosis with echocardiography
derived mean gradient >40mmHg or jet velocity greater than 4.0 m/s or an
initial valve area of <1.0 cm2 (or aortic valve area index <= 0.6 cm2/m2).
(Baseline measurement taken by echo within 30 days of procedure).
5. Subject has symptomatic aortic stenosis as demonstrated by NYHA
Functional Classification of II or greater.
6. Subject is deemed high operable risk and suitable for TAVI per the
medical opinion of the Subject Selection Committee (See Section 3.1 for
the definition of the Subject Selection Committee).
7. Subject*s predicted operative mortality or serious, irreversible morbidity
risk is <50% at 30 days.
8. In the opinion of the Subject Selection Committee and based upon
angiographic measurements, the subject has suitable peripheral vessels
and aorta to allow for access of the delivery system.
9. Subject has structurally normal cardiac anatomy.
10. Subject is willing and able to comply with all required follow-up
evaluations.

Exclusion Criteria

1. Subject has a history of a cerebral vascular accident (CVA) or transient
ischemic attack (TIA) within the past 6 months (<=180 days) of the index
procedure.
2. Subject has carotid artery disease requiring intervention.
3. Subject has evidence of a myocardial infarction (MI) (defined as: ST
Segment elevation as evidenced on 12 Lead ECG) within the past 6
months (<=180 days) of the index procedure.
4. Subject has hypertrophic cardiomyopathy.
5. Subject has a native aortic valve that is congenitally unicuspid, bicuspid,
quadricuspid or non-calcified as seen by echocardiography.
6. Subject has mitral or tricuspid valvular regurgitation (> grade III) or
moderate to severe mitral stenosis.
7. Subject has aortic root angulation >70 degrees (horizontal aorta).
8. Subject has a pre-existing prosthetic valve or prosthetic ring in any
position.
9. Subject refuses blood transfusion or surgical valve replacement.
10. Subject has resting left ventricular ejection fraction (LVEF) < 20%.
11. The subject has documented, untreated symptomatic coronary artery
disease (CAD) requiring revascularization.
12. Subject has severe basal septal hypertrophy.
13. Subject has had a percutaneous interventional or other invasive cardiac or
peripheral procedure <= 14 days of the index procedure.
14. Subject has a history of or has active endocarditis.
15. Subject has echocardiographic evidence of intracardiac mass, thrombus,
or vegetation.
16. Subject has hemodynamic instability (requiring inotropic support or
mechanical heart assistance).
17. Subject is in acute pulmonary edema or requiring intravenous diuretic
therapy to stabilize heart failure.
18. Subject with significant pulmonary disease as determined and
documented by the Investigator.
19. Subject has significant chronic steroid use as determined and documented
by the Investigator.
20. Subject has a known hypersensitivity or contraindication to anticoagulant
or antiplatelet medication.
21. Subject has renal insufficiency as evidenced by a serum creatinine > 3.0
mg/dL (265.5 µmol/L) or end-stage renal disease requiring chronic
dialysis.
22. Subject has morbid obesity defined as BMI >= 40.
23. Subject*s iliac arteries have severe calcification, tortuosity (>two 90 degree
bends), diameter <6mm, or subject has had an aorto-femoral bypass.
24. Subject has ongoing infection or sepsis.
25. Subject has blood dyscrasias (leukopenia, acute anemia,
thrombocytopenia, bleeding diathesis, or coagulopathy).
26. Subject has a current autoimmune disease that, in the opinion of the
Principal Investigator precludes the subject from study participation.
27. Subject has significant aortic disease, including:
o aortic abdominal aneurysm (AAA) >= 4cm
o thoracic aneurysm (defined as a maximal luminal diameter of 5 cm
or greater)
o marked tortuosity
o significant aortic arch atheroma or narrowing of the abdominal or
thoracic aorta
o severe tortuosity of the thoracic aorta.
28. Subject has a pre-existing endovascular stent graft in the supra- or
infrarenal aorta or pre-existing stent grafts in the ileo-femoral arteries.
29. Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding
within the past 90 days prior to the index procedure.
30. Subject is currently participating in another in