Band Versus Ring for Tricuspid Regurgitation

Inclusion Criteria:

1. Subject must be 18 years and 80 years at time of consent and must not be amember of a vulnerable population.

2. Subject or a legally authorized representative (where allowed per localregulations) must provide written informed consent prior to any trial relatedprocedure.

3. Subjects with moderate or greater tricuspid regurgitation determined by theassessment of a qualifying transthoracic echocardiogram (TTE) and/ortransesophageal echocardiogram (TEE).

4. Subjects with moderate tricuspid regurgitation will only be included in thetrial if moderate tricuspid regurgitation is accompanied by a tricuspid annulardiameter of ≥ 40mm as measured by echocardiography.

5. Isolated functional symptomatic tricuspid regurgitation of moderate to severeor greater, with annular dilatation of ≥ 40mm;

6. Requirement for concomitant left heart valve surgery;

7. Requirement for concomitant coronary artery surgery;

8. Requirement for concomitant atrial fibrillation surgery;

9. Available and able to return to the study site for post-procedural follow-upexamination;

Exclusion Criteria:

1. Patient unable or unwilling to provide informed consent;

2. Subjects with mild tricuspid regurgitation;

3. Emergency surgery;

4. Prior tricuspid valve leaflet surgery or any currently implanted prosthetictricuspid valve, or any prior transcatheter tricuspid valve procedure;

5. Subjects with percutaneous coronary intervention within prior 30 days prior toenrollment;

6. Subjects with presence of any known life threatening (non-cardiac major orprogressive disease), non-cardiac disease that will limit the subject's lifeexpectancy to less than one year;

7. Subjects with permanent or temporary pacemaker implantation;

8. Subjects with severe, irreversible pulmonary hypertension in the judgment ofthe investigator;

9. History of mitral/tricuspid endocarditis within the last 12 months;

10. Subjects with contraindication or known allergy to device's components,aspirin, anti-coagulation therapy or contrast media that cannot be adequatelypremeditated;

11. Subjects with bleeding or coagulation disorders (e.g. active peptic ulcer oractive gastrointestinal bleeding);

12. Female patient is pregnant (urine HCG test result positive) or lactating;

13. Subject is currently participating in another clinical trial that has not yetcompleted its primary endpoint;

14. Subjects with left ventricular ejection fraction (LVEF)≤20%.