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TTVR STRONG Under Coverage With Evidence Development (CED) Study
Sponsor: Edwards Lifesciences
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.
Official title: Transcatheter Tricuspid Valve Replacement (TTVR) in Patients With Severe TR ONgoing Evidence Generation (STRONG) Under Coverage With Evidence Development (CED)
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
OBSERVATIONAL
Enrollment
2044
Start Date
2025-03-19
Completion Date
2032-12-31
Last Updated
2025-03-28
Healthy Volunteers
No
Conditions
Interventions
EVOQUE
This is a retrospective, non-randomized study. The decision to intervene by TTVR with the EVOQUE device is made by the heart team.
Locations (1)
Edwards Lifesciences
Irvine, California, United States