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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
• Intervention / Treatment: Device: TRICENTOG2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTOG2 TVSTR)

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Klink, M. Sc.; Phone Number: +49 (0) 151 14140423; Email: laura.klink@lsmedcap.com
• Study Contact Backup: Name: Natasa Mitrovic, M. Sc.; Phone Number: +49 (0) 151 14116755; Email: natasa.mitrovic@lsmedcap.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 %
  • RV EF < 35 %
• Severe uncontrolled hypertension (systolic BP ≥ 180 mmHg and/or diastolic BP ≥ 110 mmHg)
• LV function defined by LVEFbp < 25 %
• Indication for intervention for any of the other heart valves or for open cardiac surgery
• Any PCI or transcatheter valvular intervention within 30 days prior to the index procedure or planned 3 months post the index procedure
• Myocardial infarction within the 30 days prior to the index procedure
• Evidence of a present thrombosis of the lower venous system
• Medical devices present in the intended implantation site that are expected to interfere with the access, proper deployment and/or function of the prosthesis
• Evidence of active endocarditis or other acute infections
• Known hypersensitivity or contraindication to anticoagulation, anti-platelet medication, or contrast media, which cannot be adequately pre-medicated
• Patients on chronic dialysis
• Thrombophilia
• Bleeding diathesis or coagulopathy
• Women of childbearing potential, defined as females who have experienced menarche and who are not permanently sterile or not postmenopausal (≥12 consecutive months without menses without an alternative medical cause)
• Patients with any known life-threating, non-cardiac disease that will limit life expectancy of the patient to less than one year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Investigational device (TRICENTO G2 TVSTR); 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]; Successful access, tracking and withdrawal of the TRICENTO G2 Delivery System [Yes/No]; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical performance and functionality of the TRICENTO G2 Bioprothesis assessed via echocardiography	Assessment via echocardiography (TEE/TTE): Fully functional bioprosthetic valve demonstrating unrestricted inflow in diastole and no backflow in systole beyond the closing volume; Exclusion of para-prosthetic leakage; Changes in hepatic vein systolic backflow	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	Change in peak central venous pressure (CVP [mmHg]) or CVP pulsatility or differential pressure [mmHg] over the prosthetic valve right atrium-central venous system.	immediately at the end of the procedure, 6 months post-implantation
Clinical performance and functionality: Assessment of device position	Assessment of device position assessed via computed tomography (CT).	6 months post-implantation
Clinical performance and functionality: Assessment of stent geometry	Assessment of stent geometry assessed via computed tomography (CT).	6 months post-implantation
Clinical performance and functionality: Assessment of inflow and outflow patency of the Bioprosthesis	Assessment of inflow and outflow patency of the Bioprosthesis assessed via computed tomography (CT).	6 months post-implantation
Clinical performance and functionality: Assessment of anatomical interaction and tissue response	Assessment of anatomical interaction and tissue response assessed via computed tomography (CT).	6 months post-implantation
Clinical benefit: Changes in the presence and severity of lower-extremity edema according to Edema severity score	Grading according to Edema severity score: Grade 0 = none (no clinical edema),; Grade 1 = ankle (up to the height of the ankle level),; Grade 2 = shin (extending to the shin); Grade 3 = thigh (extending to the thigh); Grade 4 = generalized edema (anasarca)	at baseline, 30 days, 3 months, 6 months and 12 months post-implantation
Clinical benefit: Changes in the severity of heart-failure symptoms according to NYHA classification	NYHA Classification: I No limitations: No limitations of physical activity, ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea; II Slight limitation: Slight limitation of functional activity, comfortable at rest, ordinary physical activity can cause fatigue, palpitation,, and dyspnea; III Moderate limitation: Marked limitation of physical activity, comfortable at rest, less-than-ordinary activity can cause fatigue, palpitation, and dyspnea; IV Severe limitation: Unable to carry out physical activity without discomfort, symptoms at rest	at baseline, 30 days, 3 months, 6 months and 12 months post-implantation
Clinical benefit: Changes in the functional exercise capacity assessed via 6 Minute Walk Test	Changes in participants' functional exercise capacity assessed based on the distance [m] covered during the 6 Minute Walk Test.	at baseline, 30 days, 3 months, 6 months and 12 months post-implantation
Clinical benefit: Changes in particpants' quality of life determined via Kansas City Cardiomyopathy Questionnaire	The Kansas City Cardiomyopathy Questionnaire - 12 item version (KCCQ-12) will be used to assess patient-reported health status related to heart failure, providing a validated, efficient, and sensitive measure of disease-related quality of life. The minimum value is 0 and the maximum value is 100. A higher score means a better outcome.	at baseline, 30 days, 3 months, 6 months and 12 months post-implantation
Clinical benefit: Rate of hospitalizations for heart failure (HF)	Rate of hospitalizations for heart failure (HF) within 12 months after the index procedure; with a comparison of the rates for HF-related hospitalizations within 12 months prior to the index procedure and HF-related (re-)hospitalizations within 12 months after the index procedure	12 months post-implantation
Frequency and composite of device-related or procedure-related serious adverse events (SAEs)	With SAE classification according to MDR and MDCG 2020-10.	3 months, 6 months and 12 months 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.	3 months, 6 months and 12 months post-implantation
Rate of unplanned surgery or re-intervention due to a life-threatening device or procedure failure		3 months, 6 months and 12 months post-implantation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploartory safety endpoint: Overall mortality	All deaths occurring during the clinical investigation.	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)	Imaging of cardiac structures via echocardiography, comparing TR EROA [mm^2] to baseline.	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	Imaging of cardiac structures via echocardiography, comparing TR regurgitant volume [mL] to baseline.	at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation
Exploratory performance endpoint: Changes in Tricuspid annular plane systolic excursion (TAPSE)	Imaging of cardiac structures via echocardiography, comparing TAPSE [mm] to baseline.	at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation
Exploratory performance endpoint: Changes in Right Ventricular (RV) basal diameter	Imaging of cardiac structures via echocardiography, comparing RV basal diameter [mm] to baseline.	at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation
Exploratory performance endpoint: Changes in RV mid diameter	Imaging of cardiac structures via echocardigraphy, comparing RV mid diameter [mm] to baseline.	at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation
Exploratory performance endpoint: Changes in RV longitudinal diameter	Imaging of cardiac structures via echocardiography, comparing RV longitudinal diameter [mm] to baseline.	at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation
Exploratory performance endpoint: Changes in RV end-diastolic area	Imaging of cardiac structures via echocardiography, comparing RV end-diastolic area [mm^2] to baseline.	at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation
Exploratory performance endpoint: Changes in RV end-systolic area	Imaging of cardiac structures via echocardiography, comparing RV end-systolic area [mm^2] to baseline.	at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation
Exploratory performance endpoint: Changes in Left Ventricular (LV) end-diastolic diameter	Imaging of cardiac structures via echocardiography, comparing LV end-diastolic diameter [mm] to baseline.	at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation
Exploratory performance endpoint: Changes in Right atrial (RA) diameter	Imaging of cardiac structures via echocardiography, comparing RA diameter [mm] to baseline.	at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation
Exploratory performance endpoint: Changes in RA area	Imaging of cardiac structures via echocardiography, comparing RA area [mm^2] to baseline.	at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation
Exploratory performance endpoint: Changes in Left Ventricular Ejection Fraction (LVEF)	Imaging of cardiac structures via echocardiography, comparing LVEF [percentage] to baseline.	at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation
Exploratory performance endpoint: Changes in Right Ventricular Fractional Area Change (RVFAC)	Imaging of cardiac structures via echocardiography, comparing RVFAC [percentage] to baseline.	at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation
Exploratory performance endpoint: Changes in cardiac output	Imaging of cardiac structures via echocardiography, comparing cardiac output [L/min] to baseline.	at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation
Exploratory performance endpoint: Changes in Tricuspid Regurgitation (TR) grade (accord. to TR 5-Tier Grading System by the Tricuspid Valve Academic Research Consortium (TVARC))	Imaging of cardiac structures via echocardiography, comparing TR grade (accord. to TR 5-Tier Grading System TVARC) to baseline. TR grade (accord. to TR 5-Tier Grading System TVARC): Grade 1 + = mild; Grade 2 + = moderate; Grade 3 + = severe; Grade 4 + = massive; Grade 5 + = torrential	at procedure, discharge (latest 7 days post-implantation), after 30 days, 3 moths, 6 months, 12 months post-implantation
Exploratory performance endpoint: Changes in pulmonary artery pressure (PAP)	Imaging of cardiac structures via right heart catheterization, comparing PAP [mmHg] to baseline.	6 months post-implantation
Exploratory performance endpoint: Changes in right ventricular pressure (RVP)	Imaging of cardiac structures via right heart catheterization, comparing RVP [mmHg] to baseline.	6 months post-implantation
Exploratory performance endpoint: Changes in right atrial pressure (RAP)	Imaging of cardiac structures via right heart catheterization, comparing RAP [mmHg] to baseline.	6 months post-implantation
Exploratory performance endpoint: Changes in central venous pressure (CVP)	Imaging of cardiac structures via right heart catheterization, comparing CVP [mmHg] to baseline.	6 months post-implantation
Exploratory endpoint: Changes in white blood cell count	Changes in white blood cell count [Gpt/L], comparing baseline to the respective timepoints.	at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation
Exploratory endpoint: Changes in red blood cell count	Changes in red blood cell count [Tpt/L], comparing baseline to the respective timepoints.	at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation
Exploratory endpoint: Changes in Hemoglobin	Changes in Hemoglobin [g/dL], comparing baseline to the respective timepoints.	at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation
Exploratory endpoint: Changes in Hematocrit	Changes in Hematocrit [percentage], comparing baseline to the respective timepoints.	at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation
Exploratory endpoint: Changes in C-reactive protein	Changes in C-reactive protein [mg/L], comparing baseline to the respective timepoints.	at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation
Exploratory endpoint: Changes in Lactate Dehydrogenase (LDH)	Changes in LDH [U/L], comparing baseline to the respective timepoints.	at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation
Exploratory endpoint: Changes in Serum creatinine	Changes in Serum creatinine [µmol/l], comparing baseline to the respective timepoints.	at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation
Exploratory endpoint: Changes in Estimated Glomerular Filtration Rate (eGFR)	Changes in eGFR [mL/min], comparing baseline to the respective timepoints.	at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation
Exploratory endpoint: Changes in Blood urea nitrogen	Changes in Blood urea nitrogen [mg/dL], comparing baseline to the respective timepoints.	at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation
Exploratory endpoint: Changes in Aspartate aminotransferase (ASAT)	Changes in ASAT [U/L] , comparing baseline to the respective timepoints.	at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation
Exploratory endpoint: Changes in Alanine aminotransferase (ALT)	Changes in ALT [U/L], comparing baseline to the respective timepoints.	at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation
Exploratory endpoint: Changes in Albumin	Changes in Albumin [g/L], comparing baseline to the respective timepoints.	at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation
Exploratory endpoint: Changes in Gamma-glutamyl transferase (γ-GT/GGT)	Changes in γ-GT/GGT [U/L], comparing baseline to the respective timepoints.	at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation
Exploratory endpoint: Changes in Bilirubin	Changes in Bilirubin [µmol/L], comparing baseline to the respective timepoints.	at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation
Exploratory endpoint: Changes in N-terminal pro-B-type natriuretic peptide (NT-proBNP)	Changes in NT-proBNP [pg/mL] , comparing baseline to the respective timepoints.	at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation
Exploratory endpoint: Changes in Troponin	Changes in Troponin [µg/L], comparing baseline to the respective timepoints.	at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation
Exploratory performance endpoint: Assessment of total procedural time	Assessment of total procedural time [min], defined as time elapsed between first femoral access and access closure.	during procedure
Exploratory performance endpoint: Assessment of device time	Assessment of device time [min], defined as time elapsed between introduction of device into femoral vein and complete withdrawal from the vessel.	during procedure
Exploratory performance endpoint: Assessment of total fluoroscopy time	Assessment of total fluoroscopy time [min].	during procedure
Exploratory performance endpoint: Assessment of total contrast utilization	Assessment of total contrast utilization [mL].	during procedure
Exploratory performance endpoint: Assessment of the visibility of Delivery System and Bioprothesis	Assessment of the visibility of Delivery System and Bioprothesis under fluoroscopy [Yes/No].	during procedure
Exploratory clinical benefit endpoint: Changes in subject's weight	Changes in subject's weight [kg].	at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation
Exploratory clinical benefit endpoint: Changes in intake of cardiac drugs	Any changes in the use of cardiac drugs.	at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation
Exploratory clinical benefit endpoint: Changes in intake of diuretics	Any changes in the use of diuretics.	at baseline, procedure, discharge (latest 7 days post-implantation), 30 days, 3 months, 6 months, and 12 months post-implantation

Collaborators and Investigators

• Sponsor: Medira GmbH
• Collaborators: Clinical Accelerator; LS medcap GmbH

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Heart valve; Heart diseases; Tricuspid valve; Tricuspid regurgitation; Valve replacement; Transcatheter Valve System; Bioprothesis; Catheter-based system
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Valve Diseases; Heart Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: 25-016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No