Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

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 orhas refused standard-of-care surgical and interventional therapy or has receivedstandard-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 valvestenosis/regurgitation

• Moderate mitral valve regurgitation combined with moderate aortic valvestenosis/regurgitation

• Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) < 35 ml/min/1.73m2 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 orC, 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'slife expectancy < 12 months