EFS of the DUO System for Tricuspid Regurgitation

Eligibility 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.
• 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) \<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 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 \<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 the index 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/ml or severe anemia Hb \<8 g/dl
• 28. Known patient is actively abusing drugs
• 29. Any known sensitivities or allergies to contrast (that cannot be adequately premedicated) 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 protocol procedures (including compliance with optimal medical therapy and immobility that would prevent completion of 6MWT), follow-up visits, or impact the scientific soundness of the clinical investigation result