Trials / Active Not Recruiting
Active Not RecruitingNCT05172960
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 915 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
Detailed description
This is a prospective, single arm, multicenter study. Subjects with bicuspid aortic valve morphology will be enrolled in a separate registry.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SAPIEN X4 THV | Implantation of the SAPIEN X4 valve |
Timeline
- Start date
- 2022-06-20
- Primary completion
- 2025-07-22
- Completion
- 2034-12-01
- First posted
- 2021-12-29
- Last updated
- 2025-08-14
Locations
65 sites across 4 countries: United States, Australia, Canada, New Zealand
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05172960. Inclusion in this directory is not an endorsement.