VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)

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 enr…