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Sorin Universal REgistry on Aortic Valve Replacement

NCT02679404 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 2758

Last updated 2024-03-06

No results posted yet for this study

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.

Conditions

  • Aortic Valve Disease
  • Aortic Stenosis

Sponsors & Collaborators

  • Corcym S.r.l

    lead INDUSTRY

Principal Investigators

  • Sara Gaggianesi · Corcym S.r.l

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Singapore
  • Slovakia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02679404 on ClinicalTrials.gov