Clinical Research Directory

Inclusion Criteria: 1. Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation (2-4) 2. Age≥18 and ≤85 years old 3. New York Heart Association (NYHA) Class II, III or ambulatory IV 4. Left ventricular ejection fraction (LVEF) ≥30% 5. Undergoing cardiac surgical procedure with the planned use of cardiopulmonary bypass (surgical arm only) 6. Functional tricuspid valve regurgitation pathology with a structurally normal valve; and tricuspid valve annular diameter ≥ 40 mm (or 21 mm/m2) and ≤55 mm (or 29 mm/m2) or 2-4 + FTR 7. Patient provides written Informed Consent before any study-specific tests or procedures are performed 8. Patient is willing and able to comply with all specified study evaluations Exclusion Criteria: 1. Pregnant or lactating female 2. Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg) 3. Previous tricuspid valve repair or replacement 4. Myocardial Infarction or known unstable angina within the 30-days prior to the index procedure 5. Any PCI within 30 days prior to the index procedure or planned 3 months post the index procedure 6. Life expectancy of less than 12-months 7. Severe right heart dysfunction 8. Pulmonary hypertension with PA mean 2/3 rd MAP 9. Active systemic infection 10. Pericardial infection 11. Any clinical evidence that the investigator feels would place the patient at increased risk with the deployment of the device 12. Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. severe chronic obstructive pulmonary disease, hepatic failure, cardiac disease, autoimmune disorders or conditions of severe immunosuppression) 13. Untreated coronary artery disease (CAD) requiring revascularisation unless CABG procedure is concomitant with MIA tricuspid annular repair (surgical arm only) 14. Haemodynamic instability: systolic blood pressure \<90mmHg without reduction of afterload, shock, need for inotropic medication or IABP 15. Active peptic ulcer or gastrointestinal (GI) bleeding in the past 3 months 16. Cerebrovascular event within the past 6 months 17. History of mitral/tricuspid endocarditis within the last 12 months 18. Organic tricuspid disease 19. Contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated 20. Known alcohol or drug abuser 21. Currently participating in the study of an investigational drug or device