Actively Recruiting
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
Led by Innoventric LTD · Updated on 2025-03-07
15
Participants Needed
12
Research Sites
312 weeks
Total Duration
On this page
Sponsors
I
Innoventric LTD
Lead Sponsor
I
Innoventric Inc.
Collaborating Sponsor
AI-Summary
What this Trial 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).
CONDITIONS
Official Title
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has clinically significant tricuspid regurgitation graded as severe or greater
- Peak central venous pressure of 65 15mmHg
- Patient has New York Heart Association (NYHA) functional classification of III or IV
- Patient is not eligible for or has refused standard surgical or interventional therapy, or has received such therapy and remains symptomatic
You will not qualify if you...
- Severe right ventricular dysfunction defined by TAPSE, RVEF, or RVFAC
- Unsuitable anatomy according to CT scan
- Systolic pulmonary artery pressure greater than 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) less than 35 ml/min/1.73 m2 within 60 days prior to the procedure or chronic dialysis
- Liver cirrhosis or moderate/severe liver disease (Child-Turcotte-Pugh class B or C, score 7 or higher)
- Thrombocytopenia (platelet count less than 80,000/mm3) or thrombocytosis (platelet count greater than 750,000/mm3) within 14 days of the procedure
- Life expectancy less than 12 months per investigator or eligibility committee
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Cardiovascular Institute of Los Robles Health System
Thousand Oaks, California, United States, 91360
Actively Recruiting
2
Ascension St. John
Detroit, Michigan, United States, 48236
Actively Recruiting
3
Mayo Clinic Hospital (Rochester)
Rochester, Minnesota, United States, 55902
Actively Recruiting
4
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
5
Stony Brook Heart Institute
Stony Brook, New York, United States, 11794
Actively Recruiting
6
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
7
Lankenau Heart Institute
Philadelphia, Pennsylvania, United States, 19096
Actively Recruiting
8
TriStar Centennial Medical Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
9
University of Washington Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
10
University Medicine Mainz
Mainz, Rhineland-Palatinate, Germany, 55131
Actively Recruiting
11
Helios Health Institute GmbH, Leipzig
Leipzig, Saxony, Germany, 04103
Actively Recruiting
12
German Heart Center at Charité (DHZC)
Berlin, State of Berlin, Germany, 13353
Actively Recruiting
Research Team
C
Chen Lereya
CONTACT
A
Amir Danino
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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