NCT06833476

TTVR STRONG Under Coverage With Evidence Development (CED) Study

Transcatheter Tricuspid Valve Replacement (TTVR) in Patients With Severe TR ONgoing Evidence Generation (STRONG) Under Coverage With Evidence Development (CED)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,044 (estimated)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a retrospective, non-randomized cohort study measuring 2-year effectiveness of the EVOQUE Transcatheter Tricuspid Valve Replacement (TTVR) system in the real-world. This study will retrospectively evaluate EVOQUE treated patients in the STS/ACC TVT Registry who have at least severe Tricuspid Regurgitation and can be deterministically linked with Medicare data. This group will be compared to Medicare eligible and EVOQUE eligible patients evaluated in a standard of care setting from a commercial claims database linked with electronic health records. We will evaluate the primary outcome measure in various subgroups. There will be continued access enrollment after the primary completion date.

Conditions

• Tricuspid Regurgitation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-19
• Primary completion: 2027-12-30
• Completion: 2032-12-31
• First posted: 2025-02-18
• Last updated: 2025-03-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study