Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

Recruiting now · Not applicable

Conditions studied: Tricuspid Regurgitation, Tricuspid Regurgitation Functional

In brief

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).

Key facts

Study ID

NCT06212193

Run by

Innoventric LTD

People needed

15

Starts

2024-08-05

Expected to finish

2030-08-01

Last updated by the study team

2025-03-07

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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
• 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< 80,000/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

Where it is running

• Cardiovascular Institute of Los Robles Health System — Thousand Oaks, California, United States (enrolling)
• Ascension St. John — Detroit, Michigan, United States (enrolling)
• Mayo Clinic Hospital (Rochester) — Rochester, Minnesota, United States (enrolling)
• Weill Cornell Medicine — New York, New York, United States (enrolling)
• Stony Brook Heart Institute — Stony Brook, New York, United States (enrolling)
• The Christ Hospital — Cincinnati, Ohio, United States (enrolling)
• Lankenau Heart Institute — Philadelphia, Pennsylvania, United States (enrolling)
• TriStar Centennial Medical Center — Nashville, Tennessee, United States (enrolling)
• University of Washington Medical Center — Seattle, Washington, United States (enrolling)
• University Medicine Mainz — Mainz, Rhineland-Palatinate, Germany (enrolling)
• Helios Health Institute GmbH, Leipzig — Leipzig, Saxony, Germany (enrolling)
• German Heart Center at Charité (DHZC) — Berlin, State of Berlin, Germany (enrolling)

Full record on ClinicalTrials.gov

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