TTVR STRONG Under Coverage With Evidence Development (CED) Study
NCT ID: NCT06833476
Last Updated: 2025-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2044 participants
OBSERVATIONAL
2025-03-19
2032-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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
This is a retrospective, non-randomized study. The decision to intervene by TTVR with the EVOQUE device is made by the heart team.
EVOQUE eligible
Medicare eligible patients with severe, symptomatic Tricuspid Regurgitation that are identifiable in a commercial claims database linked with electronic health records.
No interventions assigned to this group
Interventions
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EVOQUE
This is a retrospective, non-randomized study. The decision to intervene by TTVR with the EVOQUE device is made by the heart team.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
65 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Locations
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Edwards Lifesciences
Irvine, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EVOQUE CED
Identifier Type: -
Identifier Source: org_study_id
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