Evaluating a new device for replacing the tricuspid valve in patients with severe regurgitation
The TRICURE EU PIVOTAL TRiCares Topaz Transcatheter TRICUspid Heart Valve REplacement System EUropean PIVOTAL Study
NA · TRiCares · NCT06581471
This study is testing a new device to replace the tricuspid valve in adults with severe regurgitation who can't have traditional surgery to see if it is safe and works well.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | TRiCares (industry) |
| Locations | 8 sites (Aalst and 7 other locations) |
| Trial ID | NCT06581471 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multi-center study aimed at assessing the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System. The study involves adult patients diagnosed with severe tricuspid regurgitation, who are considered at increased risk for traditional surgery. Participants will receive the transcatheter valve replacement, and outcomes will be monitored to evaluate the device's effectiveness and safety. The study is designed as a single-arm trial, meaning all participants will receive the same intervention without a control group.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients with severe tricuspid regurgitation who are at increased operative risk.
Not a fit: Patients requiring emergency interventions, those who are hemodynamically unstable, or have anatomical contraindications for the device will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for patients suffering from severe tricuspid valve regurgitation.
How similar studies have performed: While this approach is relatively novel, similar studies evaluating transcatheter heart valve replacements have shown promising results in other valve conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients * Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential) * Institutional Heart Team evaluates patient as being at increased operative risk Exclusion Criteria: * Patient in need of emergent intervention * Patient who is hemodynamically unstable * Anatomical contraindications for implantation with study device * Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet
Where this trial is running
Aalst and 7 other locations
- Algemeen Stedelijk Ziekenhuis — Aalst, Belgium (RECRUITING)
- ZNA Middelheim — Antwerp, Belgium (RECRUITING)
- UZ Brussel — Brussels, Belgium (RECRUITING)
- Cliniques Universitaires Saint-Luc UCL — Brussels, Belgium (RECRUITING)
- Centre hospitalier universitaire CHU de Liège — Liège, Belgium (NOT_YET_RECRUITING)
- AZ Delta — Roeselare, Belgium (RECRUITING)
- University Medical Center of the Johannes Gutenberg University Mainz — Mainz, Germany (NOT_YET_RECRUITING)
- Ludwig Maximilian University Hospital — Munich, Germany (RECRUITING)
Study contacts
- Principal investigator: Jörg Hausleiter, MD — LMU Munich
- Study coordinator: Esther Gerteis
- Email: gerteis@tricares.de
- Phone: +41796015318
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.
Conditions: Tricuspid Valve Regurgitation, Heart Valve Disease, Cardiovascular Diseases