Tricuspid RegurgitationNCT06212193
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
A study testing Trillium™ in people with Tricuspid Regurgitation and Tricuspid Regurgitation Functional, run by Innoventric LTD at 12 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tricuspid Regurgitation, Tricuspid Regurgitation Functional
- What is being tested?
- Trillium™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 5 Aug 2024to Aug 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
12 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 2 countries
United States9 sites, 9 recruiting
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
Katy Fischesser, 513-585-1932, Katy.Fischesser@thechristhospital.com
Santiago Garcia, Dr
- Recruiting
Ascension St. John
Detroit, Michigan, 48236
Renee Bess, 313.343.4811, renee.bess@ascension.org
Amir Kaki
- Recruiting
TriStar Centennial Medical Center
Nashville, Tennessee, 37203
Bentley Abby, Abigail.Bentley@HCAhealthcare.com
Samuel Horr, Dr.
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Rose Spuhler, ros4026@med.cornell.edu
Mark Reisman, Dr.
- Recruiting
Lankenau Heart Institute
Philadelphia, Pennsylvania, 19096
Tisha Farinha, 484.476.8580, FarinhaT@MLHS.ORG
William Gray
- Recruiting
Mayo Clinic Hospital (Rochester)
Rochester, Minnesota, 55902
Mattie Reesman, Reesman.Margaret@mayo.edu
Mackram F Eleid
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
John Tushinski, jtushin@uw.edu
James M McCabe
- Recruiting
Stony Brook Heart Institute
Stony Brook, New York, 11794
Ruth J Tenzler Stein, Ruth.Stein@stonybrookmedicine.edu
Ahmad AlKhalil
- Recruiting
Cardiovascular Institute of Los Robles Health System
Thousand Oaks, California, 91360
Mane Arabyan, 8057963746, Mane.Arabyan@HCAHealthcare.com
Saibal Kar, Dr.
Germany3 sites, 3 recruiting
- Recruiting
German Heart Center at Charité (DHZC)
Berlin, State of Berlin, 13353
Haley Hartmann, 030 450 665 474, haley.hartmann@dhzc-charite.de
Tobias Daniel Trippel, Dr.
- Recruiting
Helios Health Institute GmbH, Leipzig
Leipzig, Saxony, 04103
Jospehin Kister, 0341 865 251551, Jospehin.Kister@helios-health-insitute.com
Tobias Kister, Dr.
- Recruiting
University Medicine Mainz
Mainz, Rhineland-Palatinate, 55131
Kim Laura Suder, 06131 17 6794, Studienzentrum-ZfK@unimedizin-mainz.de
Karl Patrik Kresoja, Dr.
About this study
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)
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).
Read the detailed description
Prospective, single arm, multi-center, 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).
Up to fifteen (15) patients at up to 10 US investigational sites and 3 German investigational sites will be enrolled. All enrolled study patients will be assessed at baseline, during the procedure, at discharge, and after 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years following the index procedure.
- Being tested
- Trillium™
- Keywords
- Tricuspid valve, Transcatheter, Tricuspid Regurgitation, Tricuspid valve insufficiency
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trillium™Device
Trillium™ Stent Graft for Cross-Caval Tricuspid Valve Replacement
| Study group | Role | What they receive |
|---|---|---|
| Innoventric Trillium™ Stent Graft | Experimental | Transcatheter cross-caval tricuspid valve replacement with the Innoventric Trillium™ Stent Graft Receives: Device: Trillium™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Major Adverse Events [Safety endpoint]
Rate of device or procedure-related Major Adverse Events (MAEs)
And
Rate of unplanned surgery or re-intervention due to a life-threatening device or procedure failure
Measured: at the end of the procedure, at discharge - typically within a week, and 30 days
Technical Performance
Successful access, delivery, and retrieval of the Trillium™ delivery system, device is anchored both in SVC and IVC [at the end of the procedure]
And
No need for re-intervention due to device valve regurgitation or para-stent leak [at discharge, and 30 days]
Measured: at the end of the procedure, at discharge - typically within a week, and 30 days
Secondary outcomes (2)
Rate of Major Adverse Events [Safety endpoint]
- Composite of all device or procedure-related MAEs [at 3 months, 6 months, 1, 2, 3, 4, and 5 years].
- Device thrombosis, evaluated by Echocardiography [at 30 days, 6 months, 1, 2, and 4 years].
- Device Migration as evaluated by Echocardiography or CMR [at 6 months]
Measured: at 3 months, 6 months, 1, 2, 3, 4, and 5 years
Efficacy endpoint
One or more of the following-
- TR grade as measured on the device valves by Echocardiography, or reduction in peak CVP as measured by right heart catheterization [at the end of the procedure]
- TR grade as measured on the device valves by Echocardiography [at 30 days, 6-month, 1-year, 2-year, and 4-year]
- Rate of hospitalizations for HF [at 6-month, and 1-year]
- HF functional class (NYHA) [at 30 days, 3-month, 6-month,1-year, 2-year, 3-year, 4-year, and 5-year]
- Six-minute walk test (6MWT) [at 30 days, 6-month, 1-year, 2-year, and 4-year]
- The Kansas City Cardiomyopathy Questionnaire (KCCQ) [at 30 days, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, and 5-year]
- Patient Global Assessment (PGA) for Tricuspid Regurgitation Valve Treatment [at 30 days, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, and 5-year]
Measured: at 30 days, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year, and 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start5 Aug 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innoventric LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innoventric Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212193
- Sponsor's protocol ID
- CLD-048
- Status last verified
- Nov 2024
- First submitted
- 20 Dec 2023
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes