Trials / Terminated
TerminatedNCT03618095
REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects
REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 382 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects
Detailed description
To evaluate safety and effectiveness of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Sets for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe aortic stenosis who are considered at intermediate risk for surgical valve replacement including those who have a bicuspid native valve.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LOTUS Edge Valve System | TAVR with the LOTUS Edge Valve System |
Timeline
- Start date
- 2019-01-14
- Primary completion
- 2021-03-30
- Completion
- 2021-03-31
- First posted
- 2018-08-07
- Last updated
- 2022-12-27
- Results posted
- 2022-12-27
Locations
50 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03618095. Inclusion in this directory is not an endorsement.