Clinical Research Directory

Inclusion Criteria: * 1\. Subject must be 18 years and 80 years at time of consent and must not be a member of a vulnerable population. * 2\. Subject or a legally authorized representative (where allowed per local regulations) must provide written informed consent prior to any trial related procedure. * 3\. Subjects with moderate or greater tricuspid regurgitation determined by the assessment of a qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE). * 4\. Subjects with moderate tricuspid regurgitation will only be included in the trial if moderate tricuspid regurgitation is accompanied by a tricuspid annular diameter of ≥ 40mm as measured by echocardiography. * 5\. Isolated functional symptomatic tricuspid regurgitation of moderate to severe or 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-up examination; 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 prosthetic tricuspid valve, or any prior transcatheter tricuspid valve procedure; * 5\. Subjects with percutaneous coronary intervention within prior 30 days prior to enrollment; * 6\. Subjects with presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year; * 7\. Subjects with permanent or temporary pacemaker implantation; * 8\. Subjects with severe, irreversible pulmonary hypertension in the judgment of the 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 adequately premeditated; * 11\. Subjects with bleeding or coagulation disorders (e.g. active peptic ulcer or active 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 yet completed its primary endpoint; * 14\. Subjects with left ventricular ejection fraction (LVEF)≤20%.