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
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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