Trials / Completed
CompletedNCT03471065
The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis
A Prospective, Single-arm, Multicenter Study of the SAPIEN 3 Ultra System in Intermediate Risk Patients With Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV | Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System. |
Timeline
- Start date
- 2018-06-01
- Primary completion
- 2019-12-23
- Completion
- 2025-01-21
- First posted
- 2018-03-20
- Last updated
- 2025-05-18
- Results posted
- 2021-01-19
Locations
6 sites across 2 countries: Canada, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03471065. Inclusion in this directory is not an endorsement.