RECRUITING

Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

Conditions

Tricuspid Regurgitation Tricuspid Regurgitation Functional Tricuspid valve Transcatheter Tricuspid valve insufficiency

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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)

Quick Facts

Study Start:2024-08-05

Study Completion:2030-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06212193

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.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Chen Lereya

CONTACT

+972-52-8981783

chen@innoventric.com

Amir Danino

CONTACT

+972-54-7256930

amir@innoventric.com

Study Locations (Sites)

Cardiovascular Institute of Los Robles Health System

Thousand Oaks, California, 91360

United States

Ascension St. John

Detroit, Michigan, 48236

United States

Mayo Clinic Hospital (Rochester)

Rochester, Minnesota, 55902

United States

Weill Cornell Medicine

New York, New York, 10065

United States

Stony Brook Heart Institute

Stony Brook, New York, 11794

United States

The Christ Hospital

Cincinnati, Ohio, 45219

United States

Lankenau Heart Institute

Philadelphia, Pennsylvania, 19096

United States

TriStar Centennial Medical Center

Nashville, Tennessee, 37203

United States

University of Washington Medical Center

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: Innoventric LTD

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-05

Study Completion Date2030-08

Study Record Updates

Study Start Date2024-08-05

Study Completion Date2030-08

Terms related to this study

Keywords Provided by Researchers

Tricuspid valve
Transcatheter
Tricuspid Regurgitation
Tricuspid valve insufficiency

Additional Relevant MeSH Terms

Tricuspid Regurgitation
Tricuspid Regurgitation Functional