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Procedure

Trillium™ Stent Graft for Tricuspid Regurgitation

N/A
Recruiting
Research Sponsored by Innoventric LTD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has NYHA functional classification of III or IV
Patient has clinically significant TR graded as severe or greater
Must not have
Moderate mitral valve regurgitation combined with moderate aortic valve stenosis/regurgitation
Severe RV dysfunction defined by TAPSE, RVEF, or RVFAC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 months, 6 months, 1, 2, 3, 4, and 5 years
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to test a new device called the Innoventric Trillium™ Stent Graft for treating severe tricuspid regurgitation to see if it is safe and effective."

Who is the study for?
This trial is for patients with severe tricuspid regurgitation (TR), a heart valve disease, who are in NYHA functional class III or IV, indicating advanced symptoms. Participants must have high central venous pressure and be ineligible for or have refused standard treatments, or remain symptomatic after such treatments.
What is being tested?
The Innoventric Trillium™ Stent Graft is being tested to see if it's safe and effective for treating severe TR. This early study will gather initial data on how well the device works when implanted in patients with this condition.
What are the potential side effects?
As an early feasibility study, specific side effects of the Trillium™ Stent Graft aren't listed but may include typical risks associated with heart procedures such as bleeding, infection, arrhythmia, or issues related to stent placement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart condition severely limits my physical activity.
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My heart valve issue is severe or worse.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have moderate issues with my heart valves.
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My heart's right ventricle is not functioning well.
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My liver is significantly damaged (Child-Turcotte-Pugh class B or C).
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I have a moderate or severe narrowing of my mitral valve.
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I have severe heart valve issues.
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My kidney function is very low or I am on dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 months, 6 months, 1, 2, 3, 4, and 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 months, 6 months, 1, 2, 3, 4, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Technical Performance
Secondary study objectives
Efficacy endpoint
Rate of Major Adverse Events [Safety endpoint]
Other study objectives
Observational endpoint

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Innoventric Trillium™ Stent GraftExperimental Treatment1 Intervention
Transcatheter cross-caval tricuspid valve replacement with the Innoventric Trillium™ Stent Graft

Find a Location

Who is running the clinical trial?

Innoventric LTDLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Innoventric Inc.UNKNOWN
~10 spots leftby Aug 2025
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