A Study to Establish A Sorin Universal REgistry on Aortic Valve Replacement

Overview

About this study

The purpose of this study is to establish a registry 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

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 Instructions for Use (IFU).

Exclusion Criteria:

  • None.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sertac Cicek, M.D.

Closed for enrollment

Contact information:

Glen Morris

(507) 255-1857

Morris.Glen@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20456759

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