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

Overview

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

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 dur

Primary outcome measures

• 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]
• 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]
• Frequency of device deficiencies [Time frame: 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 [Time frame: during and immediately after the procedure, at discharge (latest 7 days post-implantation), 30 days post-implantation]

Secondary outcome measures (12)

• 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]
• 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]
• Clinical performance and functionality: Assessment of device position [Time frame: 6 months post-implantation]
• Clinical performance and functionality: Assessment of stent geometry [Time frame: 6 months post-implantation]
• Clinical performance and functionality: Assessment of inflow and outflow patency of the Bioprosthesis [Time frame: 6 months post-implantation]
• Clinical performance and functionality: Assessment of anatomical interaction and tissue response [Time frame: 6 months post-implantation]
• 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]
• 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]
• 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]
• 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]
• Clinical benefit: Rate of hospitalizations for heart failure (HF) [Time frame: 12 months post-implantation]
• Frequency and composite of device-related or procedure-related serious adverse events (SAEs) [Time frame: 3 months, 6 months and 12 months post-implantation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07536724 · 25-016

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗