NCT06833476

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,044

participants targeted

Target at P75+ for all trials

Timeline
78mo left

Started Mar 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Mar 2025Dec 2032

First Submitted

Initial submission to the registry

February 13, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
29 days until next milestone

Study Start

First participant enrolled

March 19, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

2.8 years

First QC Date

February 13, 2025

Last Update Submit

March 27, 2025

Conditions

Tricuspid Regurgitation

Keywords

EVOQUECoverage with Evidence DevelopmentCEDTVT Registry

Outcome Measures

Primary Outcomes (1)

  • Composite (All-Cause Death or Heart Failure Hospitalization)

    Time to death or heart failure hospitalization after time zero

    2 years

Study Arms (2)

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

Other: EVOQUE

EVOQUE eligible

Medicare eligible patients with severe, symptomatic Tricuspid Regurgitation that are identifiable in a commercial claims database linked with electronic health records.

Interventions

EVOQUEOTHER

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

EVOQUE treated

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Medicare eligible real-world patients with severe, symptomatic tricuspid regurgitation

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edwards Lifesciences

Irvine, California, 92614, United States

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

TMTT GHER

CONTACT

949-250-3849TMTT_GHER_EVIDENCE@edwards.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2025

First Posted

February 18, 2025

Study Start

March 19, 2025

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 31, 2032

Last Updated

March 28, 2025

Record last verified: 2025-03

Locations

US(1)