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Inspiris Resilia Durability Registry

NCT03666741 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2025-06-15

No results posted yet for this study

Summary

Prospective, open-label, multicenter, European registry with a follow-up of 5 years to assess the clinical outcomes of patients younger than 60 years who undergo surgical AVR with the INSPIRIS RESILIA Aortic Valve™.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

AVR with or without CABG

Surgical aortic valve implantation with INSPIRIS RESILIA Aortic Valve™

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • Institut für Pharmakologie und Präventive Medizin

    lead NETWORK

Principal Investigators

  • Peter Bramlage, Professor · CEO IPPMed

  • Ruggero dePaulis, Professor · European Hospital Rome, Italy

  • Bart Meuris, Professor · UZ Leuven, Belgium

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-26
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • 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 NCT03666741 on ClinicalTrials.gov