Evaluating long-term outcomes of patients with severe Tricuspid Regurgitation treated with the EVOQUE valve
Transcatheter Tricuspid Valve Replacement (TTVR) in Patients With Severe TR ONgoing Evidence Generation (STRONG) Under Coverage With Evidence Development (CED)
This study looks at how well the EVOQUE valve works for people with severe Tricuspid Regurgitation over two years compared to those who receive standard treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2044 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Edwards Lifesciences Industry-sponsored |
| Locations | 1 site (Irvine, California) |
| Trial ID | NCT06833476 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the long-term health outcomes of patients suffering from severe, symptomatic Tricuspid Regurgitation who have undergone a Transcatheter Tricuspid Valve Replacement using the EVOQUE system. It is a retrospective, non-randomized cohort study that will analyze data from the STS/ACC TVT Registry and Medicare records to evaluate the effectiveness of the EVOQUE device over a two-year period. The study aims to compare outcomes of EVOQUE-treated patients with those receiving standard care, focusing on various subgroups to understand the device's impact better.
Who should consider this trial
Good fit: Ideal candidates for this study are Medicare-eligible patients with severe Tricuspid Regurgitation who have received or are eligible for the EVOQUE device.
Not a fit: Patients who are commercially insured or those with less than severe Tricuspid Regurgitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness of the EVOQUE valve, potentially improving treatment strategies for patients with Tricuspid Regurgitation.
How similar studies have performed: Other studies evaluating transcatheter valve replacements have shown promising results, suggesting that this approach may yield beneficial outcomes, although this specific study's methodology is somewhat novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Irvine, California
- Edwards Lifesciences — Irvine, California, United States (Recruiting)
Study contacts
- Study coordinator: Tmtt Gher
- Email: TMTT_GHER_EVIDENCE@edwards.com
- Phone: 949-250-3849
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.