Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve
Key facts
- Where
- Bad Oeynhausen, GermanySee the site
Where in Germany
- Heart and Diabetes Center North Rhine-WestphaliaBad Oeynhausen, GermanyContact: Tanja Rudolph, Prof.Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Institut für Pharmakologie und Präventive Medizin
- Trial code
- NCT06953206
- Record updated
- 30 July 2026
- Original description
Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.Read full original descriptionShow less
SAPIEN Ultra RESILIA Durability EU Registry - The RESOUND-EU Registry
Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.
Inclusion: 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.
Exclusion: 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; Lack of written informed consent; Emergency procedure; Pregnancy at time of TAVI; Critieria for long-term observation (1y-10y):.