Trials / Active Not Recruiting
Active Not RecruitingNCT04555967
SAPIEN 3 Ultra System PMCF
SAPIEN 3 Ultra System Post-Market Clinical Follow-up Study
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
Detailed description
To monitor and review device performance and outcomes of the SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SAPIEN 3 Ultra System | Transcatheter aortic valve implantation |
Timeline
- Start date
- 2020-06-30
- Primary completion
- 2021-09-24
- Completion
- 2026-11-01
- First posted
- 2020-09-21
- Last updated
- 2026-04-15
Locations
11 sites across 8 countries: Austria, Canada, Denmark, Finland, Germany, Italy, Netherlands, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04555967. Inclusion in this directory is not an endorsement.