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Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

Innoventric LTD · with Innoventric Inc. · NCT06212193

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–85 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
15
US sites recruiting
9
Study start
August 5, 2024
Record last updated
March 7, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Trillium™

Conditions: Tricuspid Regurgitation; Tricuspid Regurgitation Functional

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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\< 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

Recruiting US locations

  • Cardiovascular Institute of Los Robles Health System

    Thousand Oaks, CA 91360

    Site contact: Mane Arabyan · 8057963746 · Mane.Arabyan@HCAHealthcare.com

  • Ascension St. John

    Detroit, MI 48236

    Site contact: Renee Bess · 313.343.4811 · renee.bess@ascension.org

  • Mayo Clinic Hospital (Rochester)

    Rochester, MN 55902

    Site contact: Mattie Reesman · Reesman.Margaret@mayo.edu

  • Weill Cornell Medicine

    New York, NY 10065

    Site contact: Rose Spuhler · ros4026@med.cornell.edu

  • Stony Brook Heart Institute

    Stony Brook, NY 11794

    Site contact: Ruth J Tenzler Stein · Ruth.Stein@stonybrookmedicine.edu

  • The Christ Hospital

    Cincinnati, OH 45219

    Site contact: Katy Fischesser · 513-585-1932 · Katy.Fischesser@thechristhospital.com

  • Lankenau Heart Institute

    Philadelphia, PA 19096

    Site contact: Tisha Farinha · 484.476.8580 · FarinhaT@MLHS.ORG

  • TriStar Centennial Medical Center

    Nashville, TN 37203

    Site contact: Bentley Abby · Abigail.Bentley@HCAhealthcare.com

  • University of Washington Medical Center

    Seattle, WA 98195

    Site contact: John Tushinski · jtushin@uw.edu

Study contacts (from the official record)

  • Chen Lereya · +972-52-8981783 · chen@innoventric.com
  • Amir Danino · +972-54-7256930 · amir@innoventric.com
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS) (NCT06212193) | Bored Studies