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Innoventric Trillium™ Stent Graft for Tricuspid Regurgitation

This study is testing a new device called the Trillium™ Stent Graft for people with severe tricuspid regurgitation (TR), a condition where a heart valve (the tricuspid valve) doesn't close properly. The goal is to see if the Trillium™ Stent Graft is safe and works well. You might be able to join if you are between 18 and 85 years old, have severe TR, and are not a good candidate for standard treatments or have already tried them. The study will look at safety by tracking major problems and how well the device is placed during and after the procedure. The study is currently unclear about its recruitment status and plans to enroll up to 15 participants.

Study design
This is an Early Feasibility Study, meaning it's one of the first studies in humans. It's a single-arm study, so everyone receives the Trillium™ Stent Graft, and it plans to enroll up to 15 participants.
What's involved
You would be assessed at the start, during the procedure, at discharge, and then at 1, 3, and 6 months, and yearly for up to 5 years after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06212193

Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

Recruiting
NAAges 18–85InterventionalTreatment
Innoventric LTD
~15 participants
Updated 2025-03-07 on ClinicalTrials.gov
What's tested:Trillium™

At a glance

Recruiting sites
12 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Major Adverse Events [Safety endpoint]
Measured over at the end of the procedure, at discharge - typically within a week, and 30 days
+1 more outcome measured

Conditions

Tricuspid Regurgitation
Tricuspid Regurgitation Functional

Explore related trials

Tricuspid Valve Insufficiency

NCT06212193

Where you'd take part

This study runs at 12 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ascension St. John

    Detroit, Michiganstudy coordinator listed

    Recruiting

  • Cardiovascular Institute of Los Robles Health System

    Thousand Oaks, Californiastudy coordinator listed

    Recruiting

  • German Heart Center at Charité (DHZC)

    Berlin, State of Berlin, Germanystudy coordinator listed

    Recruiting

  • Helios Health Institute GmbH, Leipzig

    Leipzig, Saxony, Germanystudy coordinator listed

    Recruiting

  • Lankenau Heart Institute

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • Mayo Clinic Hospital (Rochester)

    Rochester, Minnesotastudy coordinator listed

    Recruiting

  • Stony Brook Heart Institute

    Stony Brook, New Yorkstudy coordinator listed

    Recruiting

  • The Christ Hospital

    Cincinnati, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Chen Lereya
[email protected]
+972-52-8981783
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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\< 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

What this trial measures

  • Rate of Major Adverse Events [Safety endpoint]at the end of the procedure, at discharge - typically within a week, and 30 days

    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

  • Technical Performanceat the end of the procedure, at discharge - typically within a week, and 30 days

    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 \[at discharge, and 30 days\]