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Clinical Trial Number: TRILLIUM EFS
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Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

Study ID: TRILLIUM EFS
Phase N/A
Physician Investigator(s)
Study Locations

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484.476.8580
[email protected]

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).

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Eligibility Criteria

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< 100,000/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