Actively Recruiting
Early Feasibility Study to Assess Safety and Performance of the Innoventric Trillium12 Stent Graft for Severe or Greater Tricuspid Regurgitation
Led by Innoventric LTD · Updated on 2025-03-07
15
Participants Needed
12
Research Sites
260 weeks
Total Duration
On this page
Sponsors
I
Innoventric LTD
Lead Sponsor
I
Innoventric Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the Innoventric Trillium12 Stent Graft in treating patients with severe or greater tricuspid regurgitation (TR). This Early Feasibility Study involves adults aged 18 to 85 who have significant TR and specific heart pressure and function criteria. The study focuses on a group of up to fifteen patients across multiple centers in the US and Germany. Participants will receive a transcatheter cross-caval tricuspid valve replacement using the Innoventric Trillium12 Stent Graft. This device-based treatment is assessed during a single procedure, followed by monitoring and evaluations at discharge, 1 month, 3 months, 6 months, and annually up to 5 years. The study aims to gather data on the device's safety and technical performance over time. Throughout the study, patients will undergo assessments at several time points including baseline, during the procedure, at discharge, and at multiple intervals up to five years. Researchers will monitor major adverse events and the device's technical performance primarily within the first 30 days and continue safety and efficacy evaluations annually. This comprehensive follow-up helps understand long-term effects and patient outcomes after the procedure.
CONDITIONS
Brief 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
- New York Heart Association functional classification of III or IV
- Not eligible for or has refused standard surgical or interventional therapy for tricuspid regurgitation, or remains symptomatic after standard treatment
You will not qualify if you...
- Severe right ventricular dysfunction defined by TAPSE, RVEF, or RVFAC
- Unsuitable anatomy based on 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 below 35 ml/min/1.73 m2 within 60 days or on chronic dialysis
- Liver cirrhosis or moderate/severe liver disease (Child-Turcotte-Pugh class B or C, score 7 or higher)
- Platelet count below 80,000/mm3 or above 750,000/mm3 within 14 days of procedure
- Life expectancy less than 12 months as judged by investigator or eligibility committee
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of the procedure
Participants undergo transcatheter cross-caval tricuspid valve replacement with the Innoventric Trillium™ Stent Graft.
1 procedure visit (in-person)
Duration - Up to 1 week
Participants are monitored during and immediately after the procedure to assess safety and technical performance.
Visits at discharge and end of procedure (in-person)
Duration - 5 years
Participants are followed up to assess major adverse events and efficacy at multiple time points after the procedure.
Visits at 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years (in-person)
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
A
Amir Danino
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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