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 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