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NCT Number: NCT07536724

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

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

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Key information

Conditions

Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

    Time frame: immediately at the end of procedure

    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]

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

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

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

  3. Frequency of device deficiencies

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

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

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

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

Secondary outcomes

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

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

    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

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

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

    Change in peak central venous pressure (CVP [mmHg]) or CVP pulsatility or differential pressure [mmHg] over the prosthetic valve right atrium-central venous system.

  3. Clinical performance and functionality: Assessment of device position

    Time frame: 6 months post-implantation

    Assessment of device position assessed via computed tomography (CT).

  4. Clinical performance and functionality: Assessment of stent geometry

    Time frame: 6 months post-implantation

    Assessment of stent geometry assessed via computed tomography (CT).

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

    Time frame: 6 months post-implantation

    Assessment of inflow and outflow patency of the Bioprosthesis assessed via computed tomography (CT).

  6. Clinical performance and functionality: Assessment of anatomical interaction and tissue response

    Time frame: 6 months post-implantation

    Assessment of anatomical interaction and tissue response assessed via computed tomography (CT).

  7. Clinical benefit: Changes in the presence and severity of lower-extremity edema according to Edema severity score

    Time frame: at baseline, 30 days, 3 months, 6 months and 12 months post-implantation

    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)

  8. Clinical benefit: Changes in the severity of heart-failure symptoms according to NYHA classification

    Time frame: at baseline, 30 days, 3 months, 6 months and 12 months post-implantation

    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

  9. Clinical benefit: Changes in the functional exercise capacity assessed via 6 Minute Walk Test

    Time frame: at baseline, 30 days, 3 months, 6 months and 12 months post-implantation

    Changes in participants' functional exercise capacity assessed based on the distance [m] covered during the 6 Minute Walk Test.

  10. Clinical benefit: Changes in particpants' quality of life determined via Kansas City Cardiomyopathy Questionnaire

    Time frame: at baseline, 30 days, 3 months, 6 months and 12 months post-implantation

    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.

  11. Clinical benefit: Rate of hospitalizations for heart failure (HF)

    Time frame: 12 months post-implantation

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

    Time frame: 3 months, 6 months and 12 months post-implantation

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

  13. Frequency of device deficiencies

    Time frame: 3 months, 6 months and 12 months post-implantation

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

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

    Time frame: 3 months, 6 months and 12 months post-implantation

Other outcomes

  1. Exploartory safety endpoint: Overall mortality

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

    All deaths occurring during the clinical investigation.

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

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

    Imaging of cardiac structures via echocardiography, comparing TR EROA [mm^2] to baseline.

  3. Exploratory performance endpoint: Changes in TR regurgitant volume

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

    Imaging of cardiac structures via echocardiography, comparing TR regurgitant volume [mL] to baseline.

  4. Exploratory performance endpoint: Changes in Tricuspid annular plane systolic excursion (TAPSE)

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

    Imaging of cardiac structures via echocardiography, comparing TAPSE [mm] to baseline.

  5. Exploratory performance endpoint: Changes in Right Ventricular (RV) basal diameter

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

    Imaging of cardiac structures via echocardiography, comparing RV basal diameter [mm] to baseline.

  6. Exploratory performance endpoint: Changes in RV mid diameter

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

    Imaging of cardiac structures via echocardigraphy, comparing RV mid diameter [mm] to baseline.

  7. Exploratory performance endpoint: Changes in RV longitudinal diameter

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

    Imaging of cardiac structures via echocardiography, comparing RV longitudinal diameter [mm] to baseline.

  8. Exploratory performance endpoint: Changes in RV end-diastolic area

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

    Imaging of cardiac structures via echocardiography, comparing RV end-diastolic area [mm^2] to baseline.

  9. Exploratory performance endpoint: Changes in RV end-systolic area

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

    Imaging of cardiac structures via echocardiography, comparing RV end-systolic area [mm^2] to baseline.

  10. Exploratory performance endpoint: Changes in Left Ventricular (LV) end-diastolic diameter

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

    Imaging of cardiac structures via echocardiography, comparing LV end-diastolic diameter [mm] to baseline.

  11. Exploratory performance endpoint: Changes in Right atrial (RA) diameter

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

    Imaging of cardiac structures via echocardiography, comparing RA diameter [mm] to baseline.

  12. Exploratory performance endpoint: Changes in RA area

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

    Imaging of cardiac structures via echocardiography, comparing RA area [mm^2] to baseline.

  13. Exploratory performance endpoint: Changes in Left Ventricular Ejection Fraction (LVEF)

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

    Imaging of cardiac structures via echocardiography, comparing LVEF [percentage] to baseline.

  14. Exploratory performance endpoint: Changes in Right Ventricular Fractional Area Change (RVFAC)

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

    Imaging of cardiac structures via echocardiography, comparing RVFAC [percentage] to baseline.

  15. Exploratory performance endpoint: Changes in cardiac output

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

    Imaging of cardiac structures via echocardiography, comparing cardiac output [L/min] to baseline.

  16. Exploratory performance endpoint: Changes in Tricuspid Regurgitation (TR) grade (accord. to TR 5-Tier Grading System by the Tricuspid Valve Academic Research Consortium (TVARC))

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

    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

  17. Exploratory performance endpoint: Changes in pulmonary artery pressure (PAP)

    Time frame: 6 months post-implantation

    Imaging of cardiac structures via right heart catheterization, comparing PAP [mmHg] to baseline.

  18. Exploratory performance endpoint: Changes in right ventricular pressure (RVP)

    Time frame: 6 months post-implantation

    Imaging of cardiac structures via right heart catheterization, comparing RVP [mmHg] to baseline.

  19. Exploratory performance endpoint: Changes in right atrial pressure (RAP)

    Time frame: 6 months post-implantation

    Imaging of cardiac structures via right heart catheterization, comparing RAP [mmHg] to baseline.

  20. Exploratory performance endpoint: Changes in central venous pressure (CVP)

    Time frame: 6 months post-implantation

    Imaging of cardiac structures via right heart catheterization, comparing CVP [mmHg] to baseline.

  21. Exploratory endpoint: Changes in white blood cell count

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

    Changes in white blood cell count [Gpt/L], comparing baseline to the respective timepoints.

  22. Exploratory endpoint: Changes in red blood cell count

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

    Changes in red blood cell count [Tpt/L], comparing baseline to the respective timepoints.

  23. Exploratory endpoint: Changes in Hemoglobin

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

    Changes in Hemoglobin [g/dL], comparing baseline to the respective timepoints.

  24. Exploratory endpoint: Changes in Hematocrit

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

    Changes in Hematocrit [percentage], comparing baseline to the respective timepoints.

  25. Exploratory endpoint: Changes in C-reactive protein

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

    Changes in C-reactive protein [mg/L], comparing baseline to the respective timepoints.

  26. Exploratory endpoint: Changes in Lactate Dehydrogenase (LDH)

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

    Changes in LDH [U/L], comparing baseline to the respective timepoints.

  27. Exploratory endpoint: Changes in Serum creatinine

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

    Changes in Serum creatinine [µmol/l], comparing baseline to the respective timepoints.

  28. Exploratory endpoint: Changes in Estimated Glomerular Filtration Rate (eGFR)

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

    Changes in eGFR [mL/min], comparing baseline to the respective timepoints.

  29. Exploratory endpoint: Changes in Blood urea nitrogen

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

    Changes in Blood urea nitrogen [mg/dL], comparing baseline to the respective timepoints.

  30. Exploratory endpoint: Changes in Aspartate aminotransferase (ASAT)

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

    Changes in ASAT [U/L] , comparing baseline to the respective timepoints.

  31. Exploratory endpoint: Changes in Alanine aminotransferase (ALT)

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

    Changes in ALT [U/L], comparing baseline to the respective timepoints.

  32. Exploratory endpoint: Changes in Albumin

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

    Changes in Albumin [g/L], comparing baseline to the respective timepoints.

  33. Exploratory endpoint: Changes in Gamma-glutamyl transferase (γ-GT/GGT)

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

    Changes in γ-GT/GGT [U/L], comparing baseline to the respective timepoints.

  34. Exploratory endpoint: Changes in Bilirubin

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

    Changes in Bilirubin [µmol/L], comparing baseline to the respective timepoints.

  35. Exploratory endpoint: Changes in N-terminal pro-B-type natriuretic peptide (NT-proBNP)

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

    Changes in NT-proBNP [pg/mL] , comparing baseline to the respective timepoints.

  36. Exploratory endpoint: Changes in Troponin

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

    Changes in Troponin [µg/L], comparing baseline to the respective timepoints.

  37. Exploratory performance endpoint: Assessment of total procedural time

    Time frame: during procedure

    Assessment of total procedural time [min], defined as time elapsed between first femoral access and access closure.

  38. Exploratory performance endpoint: Assessment of device time

    Time frame: during procedure

    Assessment of device time [min], defined as time elapsed between introduction of device into femoral vein and complete withdrawal from the vessel.

  39. Exploratory performance endpoint: Assessment of total fluoroscopy time

    Time frame: during procedure

    Assessment of total fluoroscopy time [min].

  40. Exploratory performance endpoint: Assessment of total contrast utilization

    Time frame: during procedure

    Assessment of total contrast utilization [mL].

  41. Exploratory performance endpoint: Assessment of the visibility of Delivery System and Bioprothesis

    Time frame: during procedure

    Assessment of the visibility of Delivery System and Bioprothesis under fluoroscopy [Yes/No].

  42. Exploratory clinical benefit endpoint: Changes in subject's weight

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

    Changes in subject's weight [kg].

  43. Exploratory clinical benefit endpoint: Changes in intake of cardiac drugs

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

    Any changes in the use of cardiac drugs.

  44. Exploratory clinical benefit endpoint: Changes in intake of diuretics

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

    Any changes in the use of diuretics.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Klink, M. Sc.

CONTACT

[email protected]

+49 (0) 151 14140423

Natasa Mitrovic, M. Sc.

CONTACT

[email protected]

+49 (0) 151 14116755

Sponsors and collaborators

Lead sponsor

Medira GmbH

Industry

Collaborators

  • Clinical Accelerator
  • LS medcap GmbH

Registry information

Acronym: FIM-TRICSTER

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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