EFS of the DUO System for Tricuspid Regurgitation

Inclusion Criteria:

1. Presence of severe or greater tricuspid regurgitation as determined by the Echo CoreLab.

2. Patient is symptomatic despite medical therapy.

3. The local Site Heart Team determines the Patient is appropriate for transcathetervalve intervention.

4. The Patient's anatomy is suitable in the judgment of the Patient SelectionCommittee.

5. Age ≥18 years

6. The Patient has been informed of the nature of the study and agrees to itsprovisions and has provided written Informed Consent.

Exclusion Criteria:

1. Patient is currently participating in another clinical investigation that couldaffect the outcome of this trial.

2. Any previous tricuspid valve intervention that would interfere with the placement ofthe 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 preventappropriate placement of the investigational device.

6. Need for concomitant surgical or interventional procedure, known at the time ofscreening (e.g., CABG, Atrial Septal Defect (ASD) repair).

7. Ejection Fraction (EF) <25%

8. Echocardiographic evidence of unstable intracardiac mass, thrombus or vegetation

9. Patient has Systolic Pulmonary Pressure (sPAP) >60 mm Hg

10. Severe hemodynamic instability: cardiogenic shock or the need for inotropic supportor 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 requiringrevascularization 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 <25 ml/min) or currently on chronic dialysis

17. Active endocarditis within 6 months of the index procedure

18. Pulmonary embolism or deep vein thrombosis within the last 6 months

19. Any surgical, interventional, or transcatheter procedure within 30 days prior to theindex procedure

20. Hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis

21. Life expectancy <1 year

22. Active infections requiring current antibiotic therapy

23. Known severe liver disease

24. Is on the waiting list for a transplant or has had a prior heart or lung transplant

25. Known active peptic ulcer or active GI bleed

26. Unable to take anticoagulant therapy

27. Any known major coagulation abnormalities, thrombocytopenia, platelets < 50,000/mlor severe anemia Hb <8 g/dl

28. Known patient is actively abusing drugs

29. Any known sensitivities or allergies to contrast (that cannot be adequatelypremedicated) and/or the device materials, including nickel and titanium

30. Patients who are pregnant or intend to become pregnant

31. Any condition making it unlikely the Patient will be able to complete all protocolprocedures (including compliance with optimal medical therapy and immobility thatwould prevent completion of 6MWT), follow-up visits, or impact the scientificsoundness of the clinical investigation result