About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Trillium™
Treatment groups
Sponsors and collaborators
Innoventric LTD
Lead sponsor
Innoventric Inc.
Collaborator