Innoventric Trillium™ Stent Graft First-in-Human (FIH) Study

Inclusion criteria

Enrolled patients must meet ALL the following criteria:

• Age >40 (no upper limit)
• Patient has clinically significant TR graded as severe based on the presence of systolic hepatic vein flow reversal, and VCW≥7mm or EROA≥40mm^2
• Symptomatic despite medical therapy; patient must be on diuretic therapy.
• Peak central venous pressure of ≥ 15mmHg
• The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid intervention
• Patient is willing and able to comply with all specified study evaluations.
• Patient has NYHA functional classification of III or IV
• Patient is not eligible for standard-of-care surgical or interventional therapy assessed by the central heart team or has refused standard-of-care surgical and interventional therapy or has received standard-of-care TR therapy and remains symptomatic
• Patient understands the nature of the study and study requirements and is willing to provide written Informed Consent prior to any study-specific procedures.

Exclusion criteria

Patients will be excluded from participation if ANY of the following criteria apply:

• Echocardiographic parameters (Any of the following):

I. LVEF < 20% II. Evidence of severe right ventricular dysfunction (e.g. right ventricular TAPSE < 13.0mm) III. IVC or SVC anatomy that precludes proper device deployment and function

• Systolic Pulmonary Artery Pressure > 70mmHg
• Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation
• Active endocarditis within 90 days of the scheduled implant
• Significant pericardial effusion
• Intra-cardiac masses, thrombi, or vegetation
• Thrombosis of the venous system
• Space-consuming lesion in the heart or on the valves, thrombus, or microbial colonization of the valves
• Untreated clinically significant coronary artery disease requiring immediate revascularization
• MI or known unstable angina within 30 days prior to the index procedure
• Any therapeutic invasive cardiac procedure within 30 days prior to the index procedure
• Any prior cardiac surgery, within 3 months of the index procedure
• Hemodynamic instability or treated with IV inotropes within 30 days of the index procedure
• Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mm Hg)
• Severe uncontrolled hypotension (SBP≤80 mmHg and/or DBP≤40 mmHg)
• Cerebrovascular Accident (CVA) within the past 90 days
• Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73 m^2 or patient is on chronic dialysis
• Significant frailty (i.e. Clinical Frailty Scale© (CFS) ≥ 7) within 90 days of the scheduled implant procedure
• Chronic liver disease with a MELD score of 20 or greater
• Chronic anemia (Hb < 9 g/L) not corrected by transfusion
• Thrombocytopenia (Platelet count< 100,000/mm3) or thrombocytosis (Platelet count > 750,000/mm3)
• Bleeding disorders or hypercoagulable state
• Active peptic ulcer or active gastrointestinal (GI) bleeding within 90 days of the scheduled implant
• Contraindication to anticoagulants or antiplatelet agents
• Currently or history of IV drug use
• Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure.
• Inability to access the femoral vein with a 24 FR guide (e.g., DVT, occluded femoral veins).
• Known allergy to stainless steel, nickel, titanium, PET or contrast agents that cannot be adequately pre-medicated.
• Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
• Impaired judgment
• Undergoing emergent or urgent treatment for tricuspid insufficiency
• Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
• Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to < 12 months
• Cardiac cachexia
• In the judgment of the Investigator, co-morbid condition(s) that could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
• Patient is under guardianship
• Presence of any prosthetic device in the SVC or IVC (excluding pace-maker, ICD and CRT leads)
• Elevated inflammatory markers within 2 weeks of the scheduled procedure (e.g. CRP>1.5mg/dL).