Inclusion Criteria:  Subject of age >18 years.  Subject with severe symptomatic tricuspid regurgitation presenting following conditions:  TR severity of at least 3 (severe) on a scale of 0 (none) to 5 (torrential), assessed by independent core lab and/or symptoms requiring use of diuretics. Subject presenting with New York Heart Association Class NYHA ≥II. Subject is not eligible for open tricuspid valve surgery due to high operative risk, as determined by a Heart Team decision.  Exclusion Criteria:  Subject in need of emergent or urgent intervention or any planned cardiac intervention within the next 12 months. Subject undergoing cardiac interventions within 30 days prior to index procedure. Subject with concomitant clinically relevant mitral, aortic, pulmonary regurgitation/stenosis. Subject who had previous tricuspid valve replacement or repair and a device is still in situ.