Transcatheter Tricuspid Valve Replacement (TTVR) in Patients With Severe TR ONgoing Evidence Generation (STRONG) Under Coverage With Evidence Development (CED)
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:
• Medicare eligible patients who have received an EVOQUE device or are EVOQUE eligible and have at least severe Tricuspid Regurgitation
Locations
United States
California
Edwards Lifesciences
RECRUITING
Irvine
Contact Information
Primary
TMTT GHER
TMTT_GHER_EVIDENCE@edwards.com
949-250-3849
Time Frame
Start Date: 2025-03-19
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 2044
Treatments
EVOQUE treated
Medicare patients with at least severe Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Replacement with the EVOQUE device and is identified in the TVT Registry
EVOQUE eligible
Medicare eligible patients with severe, symptomatic Tricuspid Regurgitation that are identifiable in a commercial claims database linked with electronic health records.
Related Therapeutic Areas
Sponsors
Leads: Edwards Lifesciences