Trials / Completed
CompletedNCT03225001
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve
Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Patients With a Failing Aortic Bioprosthetic Valve
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 197 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.
Detailed description
A prospective, single-arm, multicenter clinical trial. The trial will enroll patients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency. This is a PARTNER II nested registry.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Edwards SAPIEN XT transcatheter valve, Model 9300TFX | Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems. |
Timeline
- Start date
- 2012-06-11
- Primary completion
- 2016-12-16
- Completion
- 2020-10-28
- First posted
- 2017-07-21
- Last updated
- 2021-03-09
- Results posted
- 2018-01-09
Locations
47 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03225001. Inclusion in this directory is not an endorsement.