Status:
COMPLETED
SAPIEN 3 Ultra EU PMS
Lead Sponsor:
Edwards Lifesciences
Conditions:
Aortic Stenosis
Aortic Valve Stenosis
Eligibility:
All Genders
Up to 79 years
Brief Summary
This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural ...
Detailed Description
This is a prospective, observational, single-arm, multicentre, post-market study.
Eligibility Criteria
Inclusion
- Will undergo TAVI with the Edwards SAPIEN 3 Ultra System
- Less than 80 years of age at time of the procedure
- Low surgical risk
- Meets clinical and procedural requirements for early discharge
- The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent
Exclusion
- Medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship
- Considered to be part of a vulnerable population
- Active SARS-CoV-2 infection (Coronavirus-19 \[COVID-19\]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
- Cannot tolerate an anticoagulation/antiplatelet regimen
- Active bacterial endocarditis
- Participating in a drug or device study that has not reached its primary endpoint
Key Trial Info
Start Date :
April 20 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 22 2024
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04860752
Start Date
April 20 2021
End Date
July 22 2024
Last Update
July 29 2025
Active Locations (37)
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1
LKH-Univ. Graz Klinik, Auenbruggerplaz 15
Graz, Austria, 8036
2
Universitaetsklinikum St. Poelten, Klinik fuer Innere Medizin 3
Sankt Pölten, Austria, 3100
3
Medizinische Universitaet Vienna
Vienna, Austria, 1090
4
Helsinki University Hospital
Helsinki, Finland, 00100