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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06833476

Acronym

STRONG

Enrollment

2044

Registered

2025-02-18

Start date

2025-03-19

Completion date

2032-12-31

Last updated

2025-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tricuspid Regurgitation

Keywords

EVOQUE, Coverage with Evidence Development, CED, TVT Registry

Brief 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.

Interventions

OTHEREVOQUE

This is a retrospective, non-randomized study. The decision to intervene by TTVR with the EVOQUE device is made by the heart team.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

Medicare eligible patients who have received an EVOQUE device or are EVOQUE eligible and have at least severe Tricuspid Regurgitation

Exclusion criteria

Commercially insured patients who have received an EVOQUE device or are EVOQUE eligible or Medicare eligible patients with less than severe Tricuspid Regurgitation

Design outcomes

Primary

Measure	Time frame	Description
Composite (All-Cause Death or Heart Failure Hospitalization)	2 years	Time to death or heart failure hospitalization after time zero

Countries

United States

Contacts

Primary ContactTMTT GHER

TMTT_GHER_EVIDENCE@edwards.com949-250-3849

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026