Sorin Universal REgistry on Aortic Valve Replacement (SURE-AVR)

Corcym

Status: Terminated

Conditions: Aortic Valve Disease; Aortic Stenosis

Study type: Observational

Funder types: Industry

Identifiers

NCT02679404

APR001

Details and patient eligibility

About

Multi-center, International, Prospective, Non comparative, Non randomized, Open label.

5,000 patients to be enrolled approximately worldwide.

The objective of this registry is to collect safety and clinical performance post market data related to the procedure and follow-up of the Sorin Group aortic valve devices in accordance with the Instructions for Use (IFU).

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 in accordance with the local applicable regulations.

Full description

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.

Enrollment: 2,758 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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