Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve (NCT06953206) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve
Germany500 participantsStarted 2026-03-01
Plain-language summary
Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.
Who can participate
Age range18 Years
SexALL
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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 they're measuring
1
Early Safety
Timeframe: 1-3 months
2
Device Success
Timeframe: 1-3 months
3
Bioprosthetic Valve Failure
Timeframe: 3-5 years
4
Bioprosthetic Valve Failure
Timeframe: 9-10 years
5
Structural Valve Deterioration
Timeframe: 9-10 years
Trial details
NCT IDNCT06953206
SponsorInstitut für Pharmakologie und Präventive Medizin