Recruiting

Observational Study

Sponsor:

Edwards Lifesciences

Code:

NCT06833476

Conditions

Tricuspid Regurgitation

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

EVOQUE

Study Details

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.

Conditions

Tricuspid Regurgitation

Study ID

NCT06833476

Start date

Mar 19, 2025

Status verified date

Mar, 2025

Completion date

Dec 31, 2032

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2044 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

  • Composite (All-Cause Death or Heart Failure Hospitalization) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

TMTT GHER

949-250-3849TMTT_GHER_EVIDENCE@edwards.com

Locations

Edwards Lifesciences

Recruiting

Irvine, California, United States, 92614

Contacts

TMTT GHER

TMTT_GHER_EVIDENCE@edwards.com

More Information

Sponsor

Edwards Lifesciences

Last update posted

Mar 28, 2025

Last verified

Mar, 2025

Keywords

  • EVOQUE
  • Coverage with Evidence Development
  • CED
  • TVT Registry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Edwards Lifesciences on 2025-03-28.