CompletedNo phase
SAPIEN 3 Ultra EU PMS
Key facts
- Who runs it
- Edwards Lifesciences
- Where
- Austria, Finland, France, Germany, Italy, Norway, Portugal, Spain, Switzerland, and United Kingdom37 sites in 10 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 500 people enrolled
- Started
- 20 Apr 2021
- Ended
- 22 Jul 2024
- Type of study
- Observational
- Treatments tested
- Transcatheter Aortic Valve Implantation (TAVI)
- Record updated
- 29 July 2025
Who can take part
- Age
- Up to 79 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
- Participating in a drug or device study that has not reached its primary endpoint
- Medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship
- Considered to be part of a vulnerable population
- Cannot tolerate an anticoagulation/antiplatelet regimen
- Active bacterial endocarditis
This trial has no sites in United States.
It has sites in 10 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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 practices and facilitating early discharge home.
Treatments tested
- Transcatheter Aortic Valve Implantation (TAVI)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- SAPIEN 3 Ultra EU Post-Market Observational Study
- Record updated
- 29 July 2025