First in Human Experience of the St. Jude Medical TAVI Valve and Delivery System

First In Human Experience and Assessment of the 23mm SJM Transcatheter Aortic Valve Implant and the SJM TAVI Transfemoral Delivery System (SJM TAVI FIH)

The purpose of this first-in-human study is to assess the technical feasibility, deployment characteristics, and safety of the 23mm SJM Transfemoral Transcatheter Heart Valve and delivery system in subjects with severe symptomatic aortic stenosis (AS).

This is a single center, prospective, non-randomized, first-in-human investigational study without concurrent or matched controls.

Data will be collected at baseline, procedure, discharge (date of hospital discharge or 7 days post-implant, whichever occurs first), 30 days post implant, 3 months post implant, 6 months post implant, and 12 months post implant.

Inclusion Criteria:

1. Written Informed Consent for participation prior to procedure.
2. Legal age in host country.
3. Aortic annulus 19-21mm diameter
4. Senile degenerative aortic stenosis with 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)
5. NYHA Functional Classification of II or greater.
6. Predicted operative mortality or serious, irreversible morbidity risk is <50% at 30 days.
7. Suitable peripheral vessels and aorta to allow for access of the 18 French delivery system.

Exclusion Criteria:

1. History of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months (≤180 days) of index procedure.
2. Carotid artery disease requiring intervention.
3. Myocardial infarction (MI) within 6 months (≤180 days) of the index procedure.
4. Native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
5. Mitral or tricuspid valvular regurgitation (grade II) or moderate to severe mitral stenosis.
6. Aortic root angulation >70 degrees (horizontal aorta).
7. Pre-existing prosthetic valve or prosthetic ring in any position. LVEF < 20%.
8. Untreated coronary artery disease (CAD) requiring revascularization.
9. Severe basal septal hypertrophy.
10. Percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 14 days or history of previous endocarditis.
11. Uncontrolled atrial fibrillation (AF) or is in chronic AF without long term oral anticoagulation.
12. Evidence of intracardiac mass, thrombus, or vegetation.
13. Hemodynamic instability
14. Significant pulmonary disease.
15. Nonreactive pulmonary hypertension.
16. Chronic steroid use.
17. Hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
18. Renal insufficiency as evidenced by a serum creatinine > 3.0 or end-stage renal disease requiring chronic dialysis.
19. Morbid obesity defined as BMI ≥ 35.
20. Subject's iliac arteries have severe calcification, tortuosity, diameter <6mm, or subject has had an aorto-femoral bypass.
21. Ongoing infection or sepsis.
22. Blood dyscrasias
23. Significant aortic disease.
24. Pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the ileo-femoral arteries.
25. Active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 3 months (≤ 90 days) prior to the index procedure.