THE ALIGN-AS EFS TRIAL: JenaValve Pericardial TAVR Aortic Stenosis Study
THE ALIGN-AS EFS TRIAL: JenaValve Pericardial TAVR Aortic Stenosis Study
To collect information about treatment for severe aortic stenosis (AS), which affects the
 aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which
 decreases blood flow from the heart and causes symptoms such as chest pain, fainting and
 shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve
 replacement surgery.
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. 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.
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