Clinical Trial

First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation

Study acronym: FIM-TRICSTER
Not Yet Recruiting
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Summary
The goal of this clinical trial is to assess if the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTO G2 TVSTR) is safe and efficient in treating severe tricuspid regurgitation in adult patients. The main questions it aims to answer are: * Does the treatment with the TRICENTO G2 TVSTR improve symptoms of severe tricuspid regurgitation? * Is the treatment with the TRICENTO G2 TVSTR safe? Participants will: * Undergo a minimally invasive procedure for the implantation of the TRICENTO G2 Bioprosthesis using the TRICENTO G2 Delivery System * Visit the clinic for a baseline visit, the procedure itself, 30 days, 3 months, 6 months and 1 year after the procedure
Trial Details
NCT Number NCT07536724
Lead Sponsor Medira GmbH
Collaborators: LS medcap GmbH, Clinical Accelerator
Conditions Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
Enrollment 10 participants
Start Date 2026-05
Primary Completion 2027-11 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-04-17