Trials / Not Yet Recruiting
Not Yet RecruitingNCT06167213
ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral
Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve - Mitral
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 125 (estimated)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This study will establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater surgical risk with a failing mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring.
Detailed description
This is a prospective, single arm, multicenter, pivotal study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SAPIEN X4 THV | Implantation of the SAPIEN X4 valve |
Timeline
- Start date
- 2027-01-01
- Primary completion
- 2029-03-01
- Completion
- 2038-03-01
- First posted
- 2023-12-12
- Last updated
- 2025-12-22
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06167213. Inclusion in this directory is not an endorsement.