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

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 dysf…