A prospective, single-arm, multi-center first-in-human (FIH) study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft System.
Twenty (20) patients in 8 investigational sites will be enrolled. All enrolled study patients will be assessed at baseline, during the procedure, at discharge, after 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, and 3 years following the index procedure.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age \>40 (no upper limit)
. Patient has clinically significant TR graded as severe based on the presence of systolic hepatic vein flow reversal, and VCW≥7mm or EROA≥40mm\^2
. Symptomatic despite medical therapy; patient must be on diuretic therapy.
. Peak central venous pressure of ≥ 15mmHg
. The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid intervention
. Patient is willing and able to comply with all specified study evaluations.
. Patient has NYHA functional classification of III or IV
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety Endpoint
Timeframe: Evaluated immediately after intervention, discharge and 30 days
2
Technical performance
Timeframe: Evaluated immediately after intervention
3
Efficacy Endpoint
Timeframe: Evaluated immediately after intervention
. Patient is not eligible for standard-of-care surgical or interventional therapy assessed by the central heart team or has refused standard-of-care surgical and interventional therapy or has received standard-of-care TR therapy and remains symptomatic
Exclusion criteria
. Echocardiographic parameters (Any of the following):
. Systolic Pulmonary Artery Pressure \> 70mmHg
. Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation
. Active endocarditis within 90 days of the scheduled implant
. Significant pericardial effusion
. Intra-cardiac masses, thrombi, or vegetation
. Thrombosis of the venous system
. Space-consuming lesion in the heart or on the valves, thrombus, or microbial colonization of the valves