JenaValve Pericardial TAVR Aortic Regurgitation Study

This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), which is a
minimally invasive procedure designed to replace the aortic valve inside the heart. The
JenaValve Pericardial TAVR System will be examined in this clinical study for aortic valve
replacement. The TAVR procedure is performed by a heart surgeon and/or an interventional
cardiologist. A 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 regurgitation. 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 aortic regurgitation (AR).

- 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