First-in-man Trial TRICENTO G2 Transcatheter Valve for Tricuspid Regurgitation
Summary
The NIH ClinicalTrials.gov registry has posted a first-in-man trial for the TRICENTO G2 Transcatheter Valve System (TRICENTO G2 TVSTR) intended to treat severe tricuspid regurgitation in adult patients. The early feasibility study will assess safety, performance, and clinical benefit through 1-year follow-up. Participants will undergo minimally invasive valve implantation with clinic visits at baseline, 30 days, 3 months, 6 months, and 1 year post-procedure.
What changed
NIH ClinicalTrials.gov registered a first-in-man clinical trial for the TRICENTO G2 Transcatheter Valve System in patients with symptomatic severe or greater tricuspid regurgitation. The study will evaluate safety and efficacy through 12-month follow-up visits.
Healthcare providers and clinical investigators conducting this study must ensure compliance with applicable FDA regulations for medical device investigations, including Institutional Review Board oversight and informed consent requirements. Medical device manufacturers sponsoring similar early feasibility studies should maintain current trial registrations on ClinicalTrials.gov as required under FDA regulations.
Archived snapshot
Apr 17, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
N/A NCT07536724 Kind: NA Apr 17, 2026
Abstract
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
Conditions: Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
Interventions: TRICENTOG2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTOG2 TVSTR)
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