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

Recruiting now

Conditions studied: Transcatheter Aortic Valve Replacement (TAVR), Aortic-Stenosis, Aortic Insufficiency, Degenerative Valve Disease

In brief

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

Key facts

Study ID: NCT06953206
Run by: Institut für Pharmakologie und Präventive Medizin
People needed: 500
Starts: 2025-09-15
Expected to finish: 2037-09-30
Last updated by the study team: 2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
Freedom from surgery or intervention related to the device (excluding permanent pacemaker or PTA and stenting without major bleeding) or to a major vascular or access related, or cardiac structural complication
Absence of the following severe procedural and in-hospital complications (VARC-3 definitions):
All stroke
Bleeding type 3-4
Myocardial infarction
Need for a second valve
Valve embolization
Coronary obstruction
Annular rupture

Where it is running

Heart and Diabetes Center North Rhine-Westphalia — Bad Oeynhausen, North Rhine-Westphalia, Germany (enrolling)

Full record on ClinicalTrials.gov

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