Overview

Early Feasibility Study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR).

Eligibility

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