A Feasibility Study to Assess Safety and Efficacy of the Transapical and Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients with Symptomatic Severe Aortic Stenosis (AS) (CA-0001)/ Symptomatic Severe Aortic Regurgitation (AR) (CA-0002)

This is a feasibility clinical study sponsored by JenaValve Technology, Inc.
(the *Sponsor*) to help evaluate a new device (JenaValve Pericardial TAVR
System) to treat subjects who require replacement of their aortic heart valve
due to symptomatic severe aortic stenosis (narrow valve) or aortic
regurgitation (leaking valve).

The objective of this study is to evaluate the safety and efficacy of the
transapical and transfemoral JenaValve Pericardial TAVR System in treating
subjects with symptomatic severe aortic stenosis or symptomatic severe aortic
regurgitation requiring replacement of their native aortic valve who are at
high risk for open surgical aortic valve replacement (SAVR) and deemed to be
non-surgical candidates using a minimally invasive transcatheter aortic valve
replacement (TAVR) procedure. The study protocol will ensure consistency in the
performing the procedure, patient management, and results of the procedure. The
results of this study shall be used to support a design dossier for CE Mark
approval of the JenaValve Pericardial TAVR System for treatment of aortic
stenosis/ aortic regurgitation.

This is a prospective, multicenter, single-arm, feasibility study evaluating
the safety and efficacy of transcatheter aortic valve replacement utilizing the
JenaValve Pericardial TAVR System for the treatment of aortic stenosis or
aortic regurgitation.

Minimally invasive procedure: transcatheter aortic valve implantation (TAVI).
Also known as transcatheter aortic valve replacement (TAVR).

Burden:
Other than standard treatment laboratory measurements and echocardiography will
be performed at 6-month and 2-year follow-up. The 6 min Walking test and the
Kansas City Cardiomyopathy Questionnaire will be asked to be completed at
Baseline and at 1-, 2-year follow-up. The Modifed Rankin Scale (mRS) will be
performed at Baseline for any study patient reported with a history of stroke.
For any patient reported with new-onset stroke, the mRS will be performed
initially upon the diagnosis of stroke and then at each follow-up interval
until study completion.

Possible risks:
There are currently no known additional risks with the specific use of the
JenaValve Pericardial TAVR System. As with any medical treatment, there may be
risks that we do not know about at this time. Women who are pregnant may not
participate in this study. If you are of child bearing potential you will be
required to take a pregnancy test before you participate in this study.

Possible benefits:
• Help return the heart to its regular function.
• Decreased risk of surgery complications (such as bleeding after surgery).
• Possibility to treat aortic regurgitation.