Recruiting

Innoventric Trillium™

Sponsor:

Innoventric LTD

Code:

NCT06212193

Conditions

Tricuspid Regurgitation

Tricuspid Regurgitation Functional

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Trillium™

Study Details

Brief 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).

Conditions

Tricuspid Regurgitation

Tricuspid Regurgitation Functional

Study ID

NCT06212193

Start date

Aug 5, 2024

Status verified date

Nov, 2024

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Innoventric Trillium™ Stent Graft

Transcatheter cross-caval tricuspid valve replacement with the Innoventric Trillium™ Stent Graft

Interventions

Trillium™

Trillium™ Stent Graft for Cross-Caval Tricuspid Valve Replacement

Primary outcome measure

  • Rate of Major Adverse Events [Safety endpoint] [ Time Frame: at the end of the procedure, at discharge - typically within a week, and 30 days ]
  • Technical Performance [ Time Frame: at the end of the procedure, at discharge - typically within a week, and 30 days ]

Central Contacts and Locations

Central contacts

Chen Lereya

+972-52-8981783chen@innoventric.com

Amir Danino

+972-54-7256930amir@innoventric.com

Locations

Cardiovascular Institute of Los Robles Health System

Recruiting

Thousand Oaks, California, United States, 91360

Contacts

Mane Arabyan

8057963746Mane.Arabyan@HCAHealthcare.com

Principal Investigator:

Saibal Kar, Dr.

Ascension St. John

Recruiting

Detroit, Michigan, United States, 48236

Contacts

Renee Bess

313.343.4811renee.bess@ascension.org

Principal Investigator:

Amir Kaki

Mayo Clinic Hospital (Rochester)

Recruiting

Rochester, Minnesota, United States, 55902

Contacts

Mattie Reesman

Reesman.Margaret@mayo.edu

Principal Investigator:

Mackram F Eleid

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Rose Spuhler

ros4026@med.cornell.edu

Principal Investigator:

Mark Reisman, Dr.

Stony Brook Heart Institute

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Ruth J Tenzler Stein

Ruth.Stein@stonybrookmedicine.edu

Principal Investigator:

Ahmad AlKhalil

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Katy Fischesser

513-585-1932Katy.Fischesser@thechristhospital.com

Principal Investigator:

Santiago Garcia, Dr

Lankenau Heart Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19096

Contacts

Tisha Farinha

484.476.8580FarinhaT@MLHS.ORG

Principal Investigator:

William Gray

TriStar Centennial Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Bentley Abby

Abigail.Bentley@HCAhealthcare.com

Principal Investigator:

Samuel Horr, Dr.

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

John Tushinski

jtushin@uw.edu

Principal Investigator:

James M McCabe

More Information

Sponsor

Innoventric LTD

Last update posted

Mar 7, 2025

Last verified

Nov, 2024

Keywords

  • Tricuspid valve
  • Transcatheter
  • Tricuspid Regurgitation
  • Tricuspid valve insufficiency

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Innoventric LTD on 2025-03-07.