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

NCT07536724 | Not Yet Recruiting DMC

• 1 other identifier: 25-016
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Tricuspid regurgitation; Tricuspid valve; Transcatheter Valve System; Heart valve; Heart diseases; Valve replacement; Bioprothesis; Catheter-based system

Outcome Measures

Primary Outcomes (4)

• Technical success: Percentage of participants with successful access, delivery and retrieval of the TRICENTO G2 Delivery System AND successful deployment and correct positioning of the TRICENTO G2 Bioprosthesis measured via echocardiography

  Technical success \[given as percentage of participants\] 1. Successful access, tracking and withdrawal of the TRICENTO G2 Delivery System \[Yes/No\] 2. Successful deployment and correct positioning of the TRICENTO G2 Bioprosthesis \[Yes/No\]

  immediately at the end of procedure

• Frequency and composite of device-related or procedure-related serious adverse events (SAEs)

  With SAE classification according to MDR and MDCG 2020-10.

  during and immediately after the procedure, at discharge (latest 7 days post-implantation), 30 days post-implantation

• Frequency of device deficiencies

  Device deficiency: Inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety or performance.

  during and immediately after the procedure, at discharge (latest 7 days post-implantation), 30 days post-implantation

• Rate of unplanned surgery or re-intervention due to a life-threatening device or procedure failure

  during and immediately after the procedure, at discharge (latest 7 days post-implantation), 30 days post-implantation

Secondary Outcomes (14)

• Clinical performance and functionality of the TRICENTO G2 Bioprothesis assessed via echocardiography

  immediately at the end of the procedure, at discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, 12 months post-implantation

• Clinical performance and functionality of the TRICENTO G2 Bioprothesis assessed via right heart catheterization

  immediately at the end of the procedure, 6 months post-implantation

• Clinical performance and functionality: Assessment of device position

  6 months post-implantation

• Clinical performance and functionality: Assessment of stent geometry

  6 months post-implantation

• Clinical performance and functionality: Assessment of inflow and outflow patency of the Bioprosthesis

  6 months post-implantation

Other Outcomes (44)

• Exploartory safety endpoint: Overall mortality

  at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, 12 months post-implantation

• Exploratory performance endpoint: Changes in Tricuspid Regurgitation - Effective Regurgitant Orifice Area (TR EROA)

  at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation

• Exploratory performance endpoint: Changes in TR regurgitant volume

  at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation

Study Arms (1)

Investigational device (TRICENTO G2 TVSTR)

EXPERIMENTAL

Since the study is a single-arm study, there is only one study arm that is treated with the investigational device. The participants are treated with the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTO G2 TVSTR).

Device: TRICENTOG2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTOG2 TVSTR)

Interventions

TRICENTOG2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTOG2 TVSTR) DEVICE

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.

Investigational device (TRICENTO G2 TVSTR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with symptomatic tricuspid regurgitation (TR), graded as severe or greater (accord. to TR 5-Tier Grading System TVARC)
• Patients with TR leading to NYHA class II, III or IV or clinical signs of right heart failure
• Patients suitable for implantation of the TRICENTO G2 Bioprosthesis according to anatomical and clinical criteria assessed by computed tomography, echocardiography and/or right heart catheterization (confirmed by a heart team)
• Patients receiving optimal medical treatment for underlying diseases
• Patients being able to give informed consent
• Patients empowered and willing to comply with the study procedures

You may not qualify if:

• Superior vena cava diameter \< 22.9 mm or \> 37.1 mm (perimeter derived)
• Inferior vena cava diameter \< 27.9 mm or \> 42.9 mm (perimeter derived)
• Right atrium cavity height \< 55 mm or \> 80 mm (direct path between caval ostia)
• Peak right atrial pressure \> 50 mmHg
• Systolic pulmonary artery pressure (sPAP) \> 60 mmHg
• Pulmonary Vascular Resistance \> 3 Wood units
• Vascular conditions that do not allow for insertion and access routing of the 26 Fr Delivery System to the intended implantation site
• Known hypersensitivity, allergy or contraindication to the device's materials, e.g. Nitinol
• Echocardiographic evidence of intra-cardiac thrombus or vegetation
• Relevant tricuspid valve stenosis (e.g. determined by a mean diastolic transvalvular gradient \> 5 mmHg at a normal heart rate)
• RV dysfunction determined by multiple of the following
• TAPSE \< 10mm
• RVOT VTI \< 10 cm
• TASV/S' \< 11.5 cm/s
• RV FAC \< 30 %

Sponsors & Collaborators

• Medira GmbH: lead
• LS medcap GmbH: collaborator
• Clinical Accelerator: collaborator

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Heart Diseases

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Cardiovascular Diseases

Central Study Contacts

Laura Klink, M. Sc.

CONTACT

+49 (0) 151 14140423; laura.klink@lsmedcap.com

Natasa Mitrovic, M. Sc.

CONTACT

+49 (0) 151 14116755; natasa.mitrovic@lsmedcap.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Exploratory, interventional, single-arm, open-label, multicentre, prospective

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04