Trials / Completed
CompletedNCT04860752
SAPIEN 3 Ultra EU PMS
SAPIEN 3 Ultra EU Post-Market Observational Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 79 Years
- Healthy volunteers
- Not accepted
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 practices and facilitating early discharge home.
Detailed description
This is a prospective, observational, single-arm, multicentre, post-market study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcatheter Aortic Valve Implantation (TAVI) | Subjects will undergo TAVI |
Timeline
- Start date
- 2021-04-20
- Primary completion
- 2024-07-22
- Completion
- 2024-07-22
- First posted
- 2021-04-27
- Last updated
- 2025-07-29
- Results posted
- 2025-07-29
Locations
37 sites across 10 countries: Austria, Finland, France, Germany, Italy, Norway, Portugal, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT04860752. Inclusion in this directory is not an endorsement.