💬In plain words
What the trial is, and whether it could suit you
Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion criteria:
* 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 criteria:
* 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
💊
What it tests
- Transcatheter aortic valve (S3UR) replacement (TAVR)
Heart and Diabetes Center North Rhine-Westphalia
Bad Oeynhausen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.