Trials / Active Not Recruiting
Active Not RecruitingNCT05760989
TRISCEND JAPAN Study
Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System: Investigation of Safety and Clinical Efficacy Using a Novel Device in Patients With at Least Severe Tricuspid Regurgitation in JAPAN
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, open, non-randomized, multicenter, clinical trial to evaluate the safety and effectiveness of the Edwards EWJ-202 transcatheter tricuspid valve replacement system in the treatment of patients with at least severe tricuspid regurgitation despite medical therapy. Subjects will be followed at discharge, 30 days, 6 months and annually through 5 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System | Replacement of the native tricuspid valve through a transcatheter approach |
Timeline
- Start date
- 2023-02-06
- Primary completion
- 2025-09-30
- Completion
- 2029-09-30
- First posted
- 2023-03-09
- Last updated
- 2024-08-28
Locations
8 sites across 1 country: Japan
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05760989. Inclusion in this directory is not an endorsement.