Health Trials

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

ConditionsTranscatheter Aortic Valve Replacement (TAVR)Aortic-StenosisAortic InsufficiencyDegenerative Valve Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut für Pharmakologie und Präventive Medizin

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

Lack of written informed consent

Emergency procedure

Pregnancy at time of TAVI

Freedom from mortality

Trial design

Treatments tested in this trial

  • Transcatheter aortic valve (S3UR) replacement (TAVR)

Treatment groups

500 Participants
are divided into 1 treatment group

Sponsors and collaborators

Institut für Pharmakologie und Präventive Medizin

Lead sponsor

Source ClinicalTrials.gov