RecruitingTricuspid RegurgitationTricuspid Regurgitation Functional
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
Eligible age
18–85 yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
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).
Sponsor: Innoventric LTD
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
California
Thousand Oaks
Michigan
Detroit
Minnesota
Rochester
New York
New York · Stony Brook
Ohio
Cincinnati
Pennsylvania
Philadelphia
Tennessee
Nashville
Washington
Seattle
Source: ClinicalTrials.gov · NCT06212193 · last updated 2025-03-07