JenaValve Pericardial TAVR System Aortic Stenosis Study

This study will examine the use of a TAVR (Transcatheter Aortic Valve Replacement), which is
a minimally invasive procedure designed to replace the aortic valve inside the heart. The
TAVR procedure is performed by a heart surgeon and/or an interventional cardiologist. This
less invasive surgical approach called TAVR is offered to those patients who are high risk
for undergoing open heart surgery to replace the aortic valve. In this study, TAVR will be
performed using the JenaValve Pericardial TAVR System, which is intended to help treat severe
aortic stenosis. The JenaValve replacement valve is placed inside the aortic valve by using
the JenaValve delivery system. The JenaValve replacement valve may be implanted in one of two
ways: (1) transapical - where the valve is implanted through the chest wall, and (2)
transfemoral - where the valve is implanted through an artery in the groin. The choice of
which implant method will be used is decided by the doctor. The choice of which approach is
used is at the clinical discretion of the study physicians. The TAVR procedure typically
takes 1-2 hours to complete. The JenaValve TAVR device, once implanted, is designed to remain
permanently in place.

Inclusion Criteria:

- Patient with severe degenerative native aortic stenosis (AS).

- Patient at high risk for open surgical valve replacement

- Patient symptomatic according to NYHA functional class II or higher

Exclusion Criteria:

- Congenital uni- or bicuspid aortic valve morphology

- Previous prosthetic aortic valve (bioprosthesis or mechanical) implant

- Endocarditis or other active infection

- Need for urgent or emergent TAVR procedure for any reason

- Cardiogenic shock or hemodynamic instability requiring inotropic support or
ventricular assist device