MedTrace Logo

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

NCT07536724 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-17

No results posted yet for this study

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

Conditions

  • Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater

Interventions

DEVICE

TRICENTOG2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTOG2 TVSTR)

The TRICENTO G2 TVSTR consists of a Bioprosthesis and a Delivery System including a Loading Funnel. The Bioprosthesis is an endovascular graft-like implant in combination with a lateral valve element. It is placed into the right atrium while spanning from inferior to superior vena cava leaving the native valve apparatus untouched (heterotopic approach). The TRICENTO G2 Bioprosthesis is designed to reduce the reflux of blood into the caval system during systole while allowing for forward flow during diastole. The TRICENTO G2 Bioprosthesis is delivered minimally invasive by transfemoral venous access using a catheter-based Delivery System.

Sponsors & Collaborators

  • LS medcap GmbH

    collaborator OTHER

  • Clinical Accelerator

    collaborator INDUSTRY

  • Medira GmbH

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-11-30
Completion
2027-11-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07536724 on ClinicalTrials.gov