Evaluating long-term outcomes of patients with severe Tricuspid Regurgitation treated with the EVOQUE valve
Official title: Transcatheter Tricuspid Valve Replacement (TTVR) in Patients With Severe TR ONgoing Evidence Generation (STRONG) Under Coverage With Evidence Development (CED)
Run by Edwards Lifesciences · NCT06833476 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 2044 (estimated) |
| Sponsor | Edwards Lifesciences Industry-sponsored |
| Locations | 1 site (Irvine, California) |
| Status | Recruiting |
| Started | March 19, 2025 |
| Main results expected | December 30, 2027 |
| Study ends | December 31, 2032 |
| Registry record updated | September 29, 2026 |
| Trial ID | NCT06833476 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients who are commercially insured or those with less than severe Tricuspid Regurgitation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Edwards Lifesciences
Irvine, California, United States Recruiting
Study contacts
- Study coordinator: Tmtt Gher
- Email: TMTT_GHER_EVIDENCE@edwards.com
- Phone: 949-250-3849
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
3D Echocardiography to See How CIEDs May Worsen Tricuspid Regurgitation
This study tests whether different CIEDs (leadless pacemakers, LBBaP, and conventional pacemakers) differ in causing worsening tricuspid regurgitation, using 3D heart imaging.
-
Compare leadless and left bundle branch pacemakers for heart and valve function
This study tests whether leadless pacemakers or left bundle branch area pacing better preserve heart and tricuspid valve function in adults needing a pacemaker.
-
TriClip for treating tricuspid regurgitation in Japan
This study will see if the TriClip device is safe and helps people in Japan with symptomatic severe tricuspid regurgitation when used in routine clinical care.
-
Impact of transcatheter tricuspid valve repair on kidneys, strength, and activity in older adults
This study will try catheter-based tricuspid valve repair (TEER) in older adults with severe symptomatic tricuspid regurgitation to see if kidney function, fluid overload, and physical activity improve.
-
TARGET 2.0: Cardiovalve TR replacement for tricuspid regurgitation
This study will test a percutaneously delivered Cardiovalve tricuspid replacement via the femoral vein in adults with symptomatic severe secondary tricuspid regurgitation who are high risk for open-heart surgery.
-
Pivot Extend device to treat severe tricuspid regurgitation
This trial will try the Pivot Extend device in adults with severe, symptomatic tricuspid regurgitation to see if it safely reduces valve leakage and improves symptoms.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.