The TRICURE First in Human Trial

Inclusion Criteria: * Subject of age \>18 years. * Subject with severe symptomatic tricuspid regurgitation presenting following conditions: 1. TR severity of at least 3 (severe) on a scale of 0 (none) to 5 (torrential), assessed by independent core lab and/or 2. 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.