Clinical Research Directory

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