EFS of the DUO System for Tricuspid Regurgitation

The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).

Inclusion Criteria: 1. Presence of severe or greater tricuspid regurgitation as determined by the Echo Core Lab. 2. Patient is symptomatic despite medical therapy. 3. The local Site Heart Team determines the Patient is appropriate for transcatheter valve intervention. 4. The Patient's anatomy is suitable in the judgment of the Patient Selection Committee. 5. Age ≥18 years 6. The Patient has been informed of the nature of the study and agrees to its provisions and has provided written Informed Consent. Exclusion Criteria: 1. Patient is currently participating in another clinical investigation that could affect the outcome of this trial. 2. Any previous tricuspid valve intervention that would interfere with the placement of the investigational device. 3. Moderate or greater tricuspid valve stenosis. 4. Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation 5. Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of the investigational device. 6. Need for concomitant surgical or interventional procedure, known at the time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair). 7. Ejection Fraction (EF) \60 mm Hg 10. Severe hemodynamic instability: cardiogenic shock or the need for inotropic support or Intra-Aortic Balloon Pump (IABP) or other percutaneous ventricular assist devices 11. Severe respiratory instability with continuous use of home oxygen 12. Severe right ventricular dysfunction 13. Untreated clinically significant coronary or carotid artery disease requiring revascularization surgical or interventional PCI. 14. Stroke or transient ischemic event within 90 days prior to the index procedure 15. Acute myocardial infarction within 30 days before the index procedure 16. Renal insufficiency (eGFR \