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

 Aortic Valve Stenosis / Posted 4 weeks ago

Brief Summary

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.

 

Detailed 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.

  • Inclusion Criteria :
    • 18 Years and older
    • All sexes eligible
    • Accepts Healthy Volunteers: No
    • Sampling Method: Probability Sample
    • Study Population All patients having received a Sorin Group aortic valve device in accordance with the IFU can be included in the registry. Other than the indication and the contra-indications specified in each IFU, there are no specific inclusion and exclusion criteria since this registry has the aim to include all patients following "real life"/standard of care practices at participating centers.
    • 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
  • Study start date : May 2015
  • Study end date : May 2029
  • Wales-Based Study Contact : Please speak to your clinician
  • Principal Investigator : Cha Rajakaruna (Bristol Royal Infirmary)
Contact details

Bristol Royal Infirmary, Marlborough Street, Bristol.Bristol,England,BS2 8HW  Show Phone Number Cha.Rajakaruna@UHBristol.nhs.uk www.uhbristol.nhs.uk

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