Trials / Active Not Recruiting
Active Not RecruitingNCT04221490
2019-06 TRISCEND Study
Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy After Replacement of Tricuspid Valve With Transcatheter Device
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 228 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System
Detailed description
The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcatheter Tricuspid Valve Replacement | Replacement of the tricuspid valve through a transcatheter approach |
Timeline
- Start date
- 2020-05-06
- Primary completion
- 2024-01-05
- Completion
- 2029-01-31
- First posted
- 2020-01-09
- Last updated
- 2026-01-09
- Results posted
- 2025-01-09
Locations
20 sites across 4 countries: United States, Canada, France, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04221490. Inclusion in this directory is not an endorsement.