Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

Description

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

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Study Overview

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Study Details

Study overview

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).

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 Trillium™ Stent Graft Early Feasibility Study (EFS)

Condition
Tricuspid Regurgitation
Intervention / Treatment

-

Contacts and Locations

Thousand Oaks

Cardiovascular Institute of Los Robles Health System, Thousand Oaks, California, United States, 91360

Detroit

Ascension St. John, Detroit, Michigan, United States, 48236

Rochester

Mayo Clinic Hospital (Rochester), Rochester, Minnesota, United States, 55902

New York

Weill Cornell Medicine, New York, New York, United States, 10065

Stony Brook

Stony Brook Heart Institute, Stony Brook, New York, United States, 11794

Cincinnati

The Christ Hospital, Cincinnati, Ohio, United States, 45219

Philadelphia

Lankenau Heart Institute, Philadelphia, Pennsylvania, United States, 19096

Nashville

TriStar Centennial Medical Center, Nashville, Tennessee, United States, 37203

Seattle

University of Washington Medical Center, Seattle, Washington, United States, 98195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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\< 100,000/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

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Innoventric LTD,

Study Record Dates

2030-08