Evaluating a new device for replacing the tricuspid valve in patients with severe regurgitation
The TRICURE EFS TRiCares Topaz Transfemoral TRICUspid Heart Valve REplacement System Early Feasibility Study
This study is testing a new device to replace the tricuspid valve in adults with severe valve problems to see if it is safe and works well.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | TRiCares Industry-sponsored |
| Locations | 9 sites (Atlanta, Georgia and 8 other locations) |
| Trial ID | NCT06506942 on ClinicalTrials.gov |
What this trial studies
This study is a multi-center, prospective single arm evaluation of the TRiCares Topaz Tricuspid Valve Replacement System. It aims to assess the safety and performance of this innovative device in adult patients suffering from severe tricuspid regurgitation. The study will involve a thorough evaluation by an institutional Heart Team to determine the suitability of patients who are at increased operative risk. Participants will receive the transcatheter valve replacement intervention and will be monitored for outcomes related to safety and device performance.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients with severe tricuspid regurgitation who are considered at increased risk for traditional surgical intervention.
Not a fit: Patients requiring emergency interventions, those who are hemodynamically unstable, or those with 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 with severe tricuspid valve regurgitation, potentially improving their quality of life.
How similar studies have performed: Other studies have shown promise with similar transcatheter valve replacement approaches, indicating potential for success in this area.
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
Atlanta, Georgia and 8 other locations
- Piedmont Healthcare Inc. — Atlanta, Georgia, United States (Recruiting)
- Northwestern — Chicago, Illinois, United States (Recruiting)
- University of Michigan Hospital and Health Systems — Ann Arbor, Michigan, United States (Recruiting)
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (Recruiting)
- Columbia University Medical Center/ NewYork Presbyterian Hospital — New York, New York, United States (Recruiting)
- Montefiore — The Bronx, New York, United States (Recruiting)
- The Christ Hospital — Cincinnati, Ohio, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- St. Michaels Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Susheel Kodali, MD — Columbia University Medical Center/ NewYork Presbyterian Hospital
- 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.