Clinical Research Directory

Inclusion Criteria: * Patient has clinically significant TR graded as severe or greater * Peak central venous pressure of ≥ 15mmHg * Patient has NYHA functional classification of III or IV * Patient is not eligible for standard-of-care surgical or interventional therapy or has refused standard-of-care surgical and interventional therapy or has received standard-of-care TR therapy and remains symptomatic Exclusion Criteria: Patients will be excluded from participation if ANY of the following criteria apply: * Severe RV dysfunction defined by TAPSE, RVEF, or RVFAC. * Anatomical suitability according to CT scan. * Systolic Pulmonary Artery Pressure \> 65mmHg * Moderate or more mitral valve stenosis * Greater than moderate mitral valve regurgitation or aortic valve stenosis/regurgitation * Moderate mitral valve regurgitation combined with moderate aortic valve stenosis/regurgitation * Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) \< 35 ml/min/1.73 m2 within 60 days prior to the index procedure or patient is on chronic dialysis * Liver cirrhosis or moderate or severe liver disease (Child-Turcotte-Pugh class B or C, or a score of 7 or higher) * Thrombocytopenia (Platelet count\< 80,000/mm3) or thrombocytosis (Platelet count \> 750,000/mm3) within 14 days of the index procedure * In the opinion of the Investigator or the study eligibility committee, the patient's life expectancy \< 12 months