Active, not recruitingNo phase
SAPIEN 3 Ultra System PMCF
Key facts
- Who runs it
- Edwards Lifesciences
- Where
- Austria, Canada, Denmark, Finland, Germany, Italy, Netherlands, and United Kingdom11 sites in 8 countriesChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 200 people enrolled
- Started
- 30 Jun 2020
- Expected to end
- Nov 2026
- Type of study
- Observational
- Treatments tested
- SAPIEN 3 Ultra System
- Record updated
- 15 April 2026
Who can take part
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 2 criteriaShow less
Other criteria
- Subject meets the criteria per the Indication and Contraindications according to the current IFUs; Indication for Use: The Edwards SAPIEN 3 Ultra THV, the Edwards SAPIEN 3 THV, and the associated delivery systems are indicated for use in patients with severe, symptomatic, calcific aortic valve stenosis who are judged by a Heart Team, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% at 30 days, based on the STS risk score and other clinical comorbidities unmeasured by the STS risk calculator); Contraindications: Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis; Inability to tolerate anticoagulation/antiplatelet therapy
- Subject has provided written informed consent to comply with all study procedures and follow-up visits
This trial has no sites in United States.
It has sites in 8 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
The group in the trial
- Transcatheter aortic valve implantation
Treatment: SAPIEN 3 Ultra System
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- SAPIEN 3 Ultra System Post-Market Clinical Follow-up Study
- Record updated
- 15 April 2026