First in Human Study of the DaVingi™ TR System in the Treatment of Patients With Functional Tricuspid Regurgitation

Inclusion Criteria:

1. Severe tricuspid regurgitation as defined by American Society of Echocardiography.
2. Symptoms of right ventricular failure despite appropriate medical therapy.
3. Multidisciplinary heart team (minimum of three physicians, including cardiology andcardiac surgery representatives) recommends tricuspid annuloplasty.
4. ≥18 years old at time of enrollment.
5. LVEF ≥ 30% within 45 days prior to index implant procedure.
6. PASP < 70 mmHg via right heart catheterization (subject at rest) within 90 days priorto index implant procedure.
7. Right Ventricle TAPSE ≥ 13 mm within 45 days prior to index implant procedure.
8. Tricuspid valve annular diameter ≥ 40 mm as measured by baseline transthoracicechocardiography in the 4 chamber view within 45 days prior to index implantprocedure.
9. Subject has provided written informed consent.
10. Subject agrees to comply with all required post-procedure follow-up visits, includingdevice adjustment.

Exclusion Criteria:

1. Acutely decompensated heart failure (i.e. hemodynamically unstable or on IVinotropes).
2. Severe Right Ventricle dysfunction.
3. Primary tricuspid pathology (e.g. rheumatic, congenital, infective, etc.).
4. Previous tricuspid valve repair or replacement.
5. Transvalvular pacemaker or defibrillator lead is present.
6. Severe left-sided valve disease.
7. Right-sided intra-cardiac mass, thrombus or vegetation is present.
8. Inability to properly guide the index implant procedure using Trans-esophagusechocardiography (e.g. acoustic window not adequate).
9. Subject requires chronic dialysis or renal replacement therapy.
10. MI or known unstable angina within the 30-days prior to the implant index procedure.
11. CVA within 3 months prior to index implant procedure.
12. Bleeding disorders, active peptic ulcer or GI bleed.
13. Contraindication to anticoagulation or antiplatelet medication, based oninvestigator's opinion.
14. Chronic oral steroid or immunomodulator use (≥ 6 months) or other condition that couldimpair healing response (e.g. cardiac sarcoidosis or other chronic inflammatorydisease).
15. Any condition that, in the opinion of the investigator, may render the subject unableto complete the study (life expectancy < 1 year), or lead to difficulties for subjectcompliance with study requirements.
16. Subject is enrolled in another investigational study which has not completed therequired primary endpoint follow-up period (Note: patients involved in a long-termsurveillance phase of another study are eligible for this study).
17. Female patients who are pregnant or lactating.