VDyne System for Severe Tricuspid Valve Regurgitation

Inclusion Criteria: * Age ≥18 years old * Subject is willing and able to comply with all study evaluations and provide consent * Subject must agree not to participate in any other clinical trial for a period of one year following index procedure * New York Heart Association (NYHA) Functional Class II, III, or IV and ambulatory * At least severe symptomatic tricuspid regurgitation. * Despite adequate and Optimized Medical Therapy (OMT), subject has signs and symptoms from TR, or prior heart failure hospitalization from TR * Heart team determines that the subject is appropriate for transcatheter tricuspid valve replacement * Functional and/or degenerative TR graded as at least severe Exclusion Criteria: * Subject unable or unwilling to comply with study required testing and follow-up visits * Subject is currently participating in another clinical trial (drug, biologic, or device) that has not yet completed its primary endpoint or is likely to interfere with this study * Pregnant, lactating subjects, and /or those who plan pregnancy in the period up to one year following index procedure. * Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anticoagulation, etc.) which cannot be adequately managed medically * Life expectancy ≤12 months due to non-cardiac comorbidities * Current IV Drug user (must be free from drug abuse for ≥1 year) * Subject unable or unwilling to provide written, informed consent before study enrollment * Tricuspid valve anatomy (cardiac and vascular) that is not suitable for the VDyne System * Hypersensitivity to metals (such as nickel or titanium) * Prior tricuspid valve surgery or catheter-based therapy with permanent residual device(s) implanted that would preclude delivery or implantation of the VDyne valve (e.g., valve replacement, edge to edge repair, etc.) * Severe valvular heart disease using established echocardiographic criteria requiring intervention other than the tricuspid valve * Known significant intracardiac shunt (e.g., septal defect). * Cerebrovascular accident (stroke, TIA) within 90 days of treatment procedure * Severe lung disease (severe COPD) or continuous use of home oxygen or oral steroids * Acute myocardial infarction (AMI) within 30 days of SSC determination of eligibility * Leukopenia, chronic anemia (Hgb \< 9 g/dL), current thrombocytopenia (platelets \<70/mcL), history of bleeding diathesis, or coagulopathy * Unwilling to receive blood products * Deep vein thrombosis and/or pulmonary embolism in the last 6-months