| NCT ID | NCT06581471 |
| Status | Recruiting |
| Phase | — |
| Sponsor | TRiCares |
| Condition | Tricuspid Valve Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-08-29 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-08-29 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
Eligibility 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
Contact & Investigator
Jörg Hausleiter, MD
PRINCIPAL INVESTIGATOR
LMU Munich
Frequently Asked Questions
Who can join the NCT06581471 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tricuspid Valve Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06581471 currently recruiting?
Yes, NCT06581471 is actively recruiting participants. Contact the research team at gerteis@tricares.de for enrollment information.
Where is the NCT06581471 trial being conducted?
This trial is being conducted at Aalst, Belgium, Antwerp, Belgium, Brussels, Belgium, Brussels, Belgium and 4 additional locations.
Who is sponsoring the NCT06581471 clinical trial?
NCT06581471 is sponsored by TRiCares. The principal investigator is Jörg Hausleiter, MD at LMU Munich. The trial plans to enroll 80 participants.