Sorin Universal REgistry on Aortic Valve Replacement

SURE-AVR objective is to collect post market safety and performance data collected along the
procedure and the relevant follow-up with Sorin Group aortic valve devices in accordance with
the IFU to further evidence the safety and efficacy in a post-approval environment. All
current and future Sorin Group aortic valve devices that have obtained CE-mark or other local
regulatory and/or commercial approvals may be included in the registry. During the duration
of the registry,other aortic valve replacement products or current devices might receive
modifications and might become commercial available. This registry allows extensions for the
inclusion of new products.

This observational global registry is intended to collect data without requiring any
deviation from the standard of care and IFU in each participating center. The participating
centers shall include those patients that have provided their informed consent to participate
in this registry following the local applicable regulations.

The data collection shall be performed as per the local standard of care and without exposing
the patient to any additional risk to the treatment (s)he would normally receive.

The registry is an open-ended project:

- Inclusions phase: open-ended

- Follow-up phase: annually throughout 5 years (7 and 10 years are optional).

The study shall be completed after the 10-year follow-up of the last patient.

Inclusion Criteria:

- All patients must provide written or oral informed consent to participate in the
registry depending on the local regulations.

- Patients having received a Sorin Group aortic valve device in accordance with the IFU

Exclusion Criteria: NA