TTVR STRONG Under Coverage With Evidence Development (CED) Study
NCT06833476 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2044
Last updated 2025-03-28
Summary
This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Replacement procedure using the EVOQUE system.
Conditions
- Tricuspid Regurgitation
Interventions
- OTHER
-
EVOQUE
This is a retrospective, non-randomized study. The decision to intervene by TTVR with the EVOQUE device is made by the heart team.
Sponsors & Collaborators
-
Edwards Lifesciences
lead INDUSTRY
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-19
- Primary Completion
- 2027-12-30
- Completion
- 2032-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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