RecruitingTranscatheter Aortic Valve Replacement (TAVR)Aortic-StenosisAortic Insufficiency
Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.
Sponsor: Institut für Pharmakologie und Präventive Medizin
You may qualify if…
- ✓ Adult patients (≥18 years)
- ✓ Patients with severe aortic stenosis undergoing transfemoral TAVI on their native valve with S3UR valve
- ✓ Patient is willing to attend the follow-up visits up to 10 years at the center
You may not qualify if…
- ✕ Lack of written informed consent
- ✕ Emergency procedure
- ✕ Pregnancy at time of TAVI
- ✕ Critieria for long-term observation (1y-10y):
- ✕ Technical success at exit from procedure room (VARC-3):
- ✕ Freedom from mortality
- ✕ Successful access, delivery of the device, and retrieval of the delivery system
- ✕ Correct positioning of a single prosthetic heart valve into the proper anatomical location
Source: ClinicalTrials.gov · NCT06953206 · last updated 2026-07-30