TRI-SUCCESS - Tricuspid Regurgitation Study of the Unica™ Cross-Caval System for the Evaluation of Efficacy and Safety in Significant TR Subjects

Prospective, multi-center, randomized, open-label, controlled pivotal study to assess the safety and effectiveness of the Innoventric Unica™ heterotopic cross-caval stent with OMT compared to OMT alone in the treatment of severe or greater TR.

Inclusion Criteria: * 18 ≤ Age ≤ 85 * Clinically symptomatic severe or greater tricuspid regurgitation * Symptomatic (NYHA functional classification of II-IVa), despite OMT. * The subject is deemed unsuitable for tricuspid valve surgery, tricuspid transcatheter edge-to-edge repair (t-TEER), or orthotopic transcatheter tricuspid valve replacement (TTVR), as determined by a multidisciplinary Heart Team. * Peak central venous pressure or peak RA pressure of ≥ 12mmHg * HF hospitalizations ≥ 1 in the past year Exclusion Criteria: * Echocardiographic parameters (Any of the following): 1. LVEF \< 30% 2. Severe RV dysfunction * Anatomical suitability according to CT scan * Systolic Pulmonary Artery Pressure (measured per RHC) \> 65mmHg or PVR \>4 WU * Moderate or greater tricuspid or mitral valve stenosis, or greater than moderate mitral valve regurgitation or greater than moderate aortic valve stenosis/regurgitation * Moderate mitral valve regurgitation combined with moderate aortic valve stenosis/regurgitation * A Patent Foramen Ovale (PFO) or an Atrial Septal Defect (ASD) that cannot be closed. * A Ventricular Septal Defect (VSD) * 6MWD \< 100m * Any therapeutic invasive cardiac procedure (excluding PFO/ASD closure and pericardiocentesis for pericardial effusion drainage) in the 30 days prior to enrollment * Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73 m2 within 60 days, or the subject is on chronic dialysis * Liver cirrhosis or moderate or severe liver disease (Child-Turcotte Pugh class C) * Chronic anemia (Hb \< 8.5 g/dL) within 14 days * Thrombocytopenia (platelet count\< 80,000/mm3) or thrombocytosis (platelet count \> 750,000/mm3) within 14 days * Active or history of malignancy that, is likely to result in cancer related morbidity or mortality, require systemic anti-cancer therapy during the study follow-up period, or otherwise confound assessment of study endpoints. * Current or history of drug or alcohol abuse within the last 3 years. * Subject's life expectancy \< 12 months * Presence of any prosthetic device in the SVC or IVC or RA that prevents proper device implantation