Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve

NCT06953206 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-03-30

No results posted yet for this study

Summary

Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.

Conditions

  • Transcatheter Aortic Valve Replacement (TAVR)
  • Aortic-Stenosis
  • Aortic Insufficiency
  • Degenerative Valve Disease

Interventions

PROCEDURE

Transcatheter aortic valve (S3UR) replacement (TAVR)

Elective transfemoral TAVi procedure with S3UR valve.

Sponsors & Collaborators

  • Institut für Pharmakologie und Präventive Medizin

    lead NETWORK

Principal Investigators

  • Tanja Rudolph, Prof. · Heart and Diabetes Center North Rhine-Westphalia University Hospital of the Ruhr University Bochum

  • Michael Joner, Prof · German Heart Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2037-05-30
Completion
2037-09-30

Countries

  • Germany

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 NCT06953206 on ClinicalTrials.gov