Status:
NOT_YET_RECRUITING
Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve
Lead Sponsor:
Institut für Pharmakologie und Präventive Medizin
Conditions:
Transcatheter Aortic Valve Replacement (TAVR)
Aortic-Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.
Detailed Description
Transcatheter aortic valve replacement (TAVI) has become the gold standard treatment for moderate-to-high risk elderly patients with severe symptomatic aortic stenosis. Based on the results of randomi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2037
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06953206
Start Date
September 1 2025
End Date
September 30 2037
Last Update
June 29 2025
Active Locations (1)
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1
Heart and Diabetes Center North Rhine-Westphalia
Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545