CoreValve Evolut Pro Registry

The CoreValve Evolut PRO transcatheter aortic valve was approved by the FDA in March 2017 to
treat patients with symptomatic severe aortic stenosis at high or extreme risk for open heart
surgery, and in July 2017 for intermediate risk patients. This latest generation device
features an outer wrap to improve annular sealing and reduce paravalvular leak.

In this observational study, baseline demographic and imaging characteristics, procedural
details and clinical outcomes of patients undergoing transcatheter aortic valve replacement
with the CoreValve Evolut PRO will be prospectively collected into a registry database. The
institutional Heart Team will select patients according to standard practice.

Inclusion Criteria:

1. Symptomatic severe aortic stenosis

2. Intermediate, high or extreme surgical risk

3. The institutional Heart Team determines that transcatheter aortic valve replacement
with an Evolut Pro device is appropriate

Exclusion Criteria:

1. Subject unable or unwilling to give informed consent

2. For subjects in the CT arm only, renal function precluding the administration of
iodinated contrast for cardiac CT (eGFR < 30 ml/min/1.73m2). An exception to this
exclusion criterion is made if the subject is established on renal replacement therapy
and is therefore able to receive intravenous iodinated contrast media.

3. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up
procedures