Trials / Active Not Recruiting
Active Not RecruitingNCT03193801
PARTNER 3 Trial - Mitral Valve in Valve
PARTNER 3 Trial - SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 53 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
To assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
Detailed description
A prospective, single-arm, multicenter clinical trial. This study will enroll patients with symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed, insufficient, or combined).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Edwards SAPIEN 3 transcatheter valve, Model 9600TFX | Edwards SAPIEN 3 THV system Model 9600TFX with the associated delivery systems. |
Timeline
- Start date
- 2018-02-01
- Primary completion
- 2022-08-16
- Completion
- 2031-08-01
- First posted
- 2017-06-21
- Last updated
- 2025-11-05
- Results posted
- 2023-10-24
Locations
12 sites across 3 countries: United States, Australia, Brazil
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03193801. Inclusion in this directory is not an endorsement.