Trials / Terminated
TerminatedNCT02202434
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
REPRISE III: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Randomized Clinical Evaluation
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,425 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical valve replacement.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Lotus Valve System | Procedure: Transcatheter aortic valve replacement (TAVR) |
| DEVICE | CoreValve/Evolut R Transcatheter Aortic Valve Replacement System | Procedure: Transcatheter aortic valve replacement (TAVR) |
| DEVICE | LOTUS Edge Valve System | Procedure: Transcatheter aortic valve replacement (TAVR) |
Timeline
- Start date
- 2014-09-22
- Primary completion
- 2017-03-08
- Completion
- 2021-05-21
- First posted
- 2014-07-29
- Last updated
- 2021-12-17
- Results posted
- 2019-07-30
Locations
58 sites across 6 countries: United States, Australia, Canada, France, Germany, Netherlands
Source: ClinicalTrials.gov record NCT02202434. Inclusion in this directory is not an endorsement.