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Recruiting

NCT Number: NCT06833476

TTVR STRONG Under Coverage With Evidence Development (CED) Study

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.

Recruiting

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Edwards Lifesciences

Irvine, California, 92614, United States

Location status: Recruiting

Location contact

TMTT GHER

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EVOQUE

Other

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

Primary outcomes

  1. Composite (All-Cause Death or Heart Failure Hospitalization)

    Time frame: 2 years

    Time to death or heart failure hospitalization after time zero

Study contacts

Contact information is provided by the study sponsor or research team.

TMTT GHER

CONTACT

[email protected]

949-250-3849

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

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

Acronym: STRONG

Important dates

Study start
2025
Primary completion
2027
Study completion
2032
First posted
Feb 18, 2025
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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