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

RECRUITINGSponsored by Institut für Pharmakologie und Präventive Medizin
Actively Recruiting
SponsorInstitut für Pharmakologie und Präventive Medizin
Started2025-09-15
Est. completion2037-05-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06953206

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions5

Aortic InsufficiencyAortic StenosisDegenerative Valve DiseaseHeart DiseaseTranscatheter Aortic Valve Replacement (TAVR)

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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