TTVR STRONG Under Coverage With Evidence Development (CED) Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EVOQUE.
- Who it may be relevant to
- Registry conditions: Tricuspid Regurgitation. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transcatheter Tricuspid Valve Replacement (TTVR) in Patients With Severe TR ONgoing Evidence Generation (STRONG) Under Coverage With Evidence Development (CED)
Overview
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
- Other 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 measures
- Composite (All-Cause Death or Heart Failure Hospitalization) [Time frame: 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Edwards Lifesciences — Irvine
Identifiers
NCT: NCT06833476 · EVOQUE CED