Trials / Withdrawn
WithdrawnNCT02964962
REPRISE EDGE 29 mm EU Study
REPRISE EDGE 29 mm EU Study: REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE 29 mm Valve - Evaluation of Safety and Performance
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The objective of the REPRISE EDGE 29 mm EU study is to evaluate performance and safety of the 29 mm 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 aortic valve replacement (SAVR).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 29 mm LOTUS Edge™ Valve System | Transcatheter aortic valve replacement |
Timeline
- Start date
- 2018-04-01
- Primary completion
- 2018-10-30
- Completion
- 2018-12-30
- First posted
- 2016-11-16
- Last updated
- 2019-07-05
Source: ClinicalTrials.gov record NCT02964962. Inclusion in this directory is not an endorsement.