Early Feasibility Study (EFS) to Assess the Safety and Performance of the Innoventric Trillium™ Stent Graft in the Treatment of Severe or Greater Tricuspid Regurgitation (TR)
Innoventric LTD
Summary
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).
Description
Prospective, single arm, multi-center, Early Feasibility Study (EFS) to assess the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR). Up to fifteen (15) patients at up to 10 US investigational sites and 3 German investigational sites will be enrolled. All enrolled study patients will be assessed at baseline, during the procedure, at discharge, and after 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years following the index procedure.
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
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 a…
Interventions
- DeviceTrillium™
Trillium™ Stent Graft for Cross-Caval Tricuspid Valve Replacement
Locations (12)
- Cardiovascular Institute of Los Robles Health SystemThousand Oaks, California
- Ascension St. JohnDetroit, Michigan
- Mayo Clinic Hospital (Rochester)Rochester, Minnesota
- Weill Cornell MedicineNew York, New York
- Stony Brook Heart InstituteStony Brook, New York
- The Christ HospitalCincinnati, Ohio