Trillium™ Stent Graft for Tricuspid Regurgitation

Recruiting at 11 trial locations

Overseen By Amir Danino

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Innoventric LTD

Disqualifiers: Severe RV dysfunction, Kidney dysfunction, Liver cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Trillium™ Stent Graft to determine its safety and effectiveness in treating severe tricuspid regurgitation (TR), a condition where the heart's tricuspid valve fails to close properly, causing blood to flow backward. The study targets patients with significant TR whose symptoms, such as difficulty breathing or fatigue, impact daily life and who cannot or choose not to undergo standard surgeries or treatments. The trial seeks participants experiencing severe TR symptoms who have been deemed unsuitable for other common treatments.

As an unphased trial, this study provides patients with access to innovative treatment options not yet widely available.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the Trillium™ Stent Graft is safe for treating tricuspid regurgitation?

Research has shown that the Trillium™ Stent Graft is under careful study for its safety in treating severe tricuspid regurgitation, a leaky heart valve. Earlier studies with patients indicated that the device could be used safely. These studies assessed whether doctors could place the device correctly and if it remained in place without issues.

Although this treatment is still in early testing stages, no major safety problems have been reported so far. It's important to note that these findings come from limited early research. While some evidence suggests the device is safe, more research is needed to confirm these results.

Participants should feel encouraged by these initial findings but should also stay informed, as further studies may provide more detailed safety information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for tricuspid regurgitation, which often involve open-heart surgery or medication to manage symptoms, the Trillium™ Stent Graft offers a minimally invasive option. Researchers are excited about this treatment because it uses a transcatheter approach, allowing for a cross-caval tricuspid valve replacement without the need for major surgery. This innovative method potentially reduces recovery time and risks associated with surgical procedures, making it a promising alternative for patients who might not be candidates for traditional surgery.

What evidence suggests that the Trillium™ Stent Graft is effective for tricuspid regurgitation?

Research has shown that the Innoventric Trillium™ Stent Graft, which participants in this trial will receive, may help treat severe tricuspid regurgitation (TR), a condition where blood flows backward into the heart's right atrium. In an initial study with humans, most patients who received the Trillium stent graft experienced significant improvements. Recent data indicated a high survival rate of 90.1% after one year, with 88.4% of patients avoiding hospital stays due to heart failure. These results suggest that the Trillium stent graft could effectively treat people with severe TR. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am not eligible for or have refused standard surgery and remain symptomatic despite treatment.

Peak central venous pressure of ≥ 15mmHg

My heart condition severely limits my physical activity.

Exclusion Criteria

I have moderate issues with my heart valves.

Thrombocytopenia (Platelet count< 100,000/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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Transcatheter cross-caval tricuspid valve replacement with the Innoventric Trillium™ Stent Graft

1 day

1 visit (in-person)

Post-procedure Monitoring

Participants are monitored for immediate safety and device performance post-procedure

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Multiple visits at 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Trillium™

Trial Overview

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.

How Is the Trial Designed?

Group I: Innoventric Trillium™ Stent Graft Experimental Treatment 1 Intervention

Transcatheter cross-caval tricuspid valve replacement with the Innoventric Trillium™ Stent Graft

Trillium™ is already approved in European Union for the following indications:

Approved in European Union as Trillium Stent Graft for:

• Severe or greater tricuspid regurgitation (TR)

Who Is Running the Clinical Trial?

Innoventric LTD

Lead Sponsor

Trials

2

Recruited

40+

Innoventric Inc.

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

The LuX-Valve is a new transcatheter system for replacing the tricuspid valve, showing promising results in a patient with severe tricuspid regurgitation (TR) after four years of follow-up.

The patient experienced significant improvement in clinical symptoms and stable hemodynamics, indicating that the LuX-Valve is a safe and effective alternative to traditional open-heart surgery for treating severe TR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

4-Year Follow-Up after Transatrial Transcatheter Tricuspid Valve Replacement with the LuX-Valve. Ning, X., Cao, J., Wang, W., et al.[2022]

A new interventional approach using a self-expandable biological prosthetic valve was successfully tested in six pigs, showing proper fitting and function in the tricuspid position without major trauma to surrounding tissues.

The study demonstrated the feasibility of this technique for treating tricuspid regurgitation (TR), marking a significant step towards developing effective interventions for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new approach to the interventional therapy of tricuspid regurgitation. Amerini, AL., Malasa, M., Hatam, N., et al.[2022]

In a study involving 13 sheep, percutaneous implantation of valved stents in the inferior and superior vena cava successfully reduced severe tricuspid regurgitation (TR) and improved cardiac output (CO), demonstrating a potential alternative to traditional open surgery.

The procedure was technically feasible, with no observed macroscopic damage post-implantation, suggesting it could be a safer option for patients with high-grade TR who are at high risk for open heart surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous caval stent valve implantation: investigation of an interventional approach for treatment of tricuspid regurgitation. Lauten, A., Figulla, HR., Willich, C., et al.[2010]

The Incraft aortic stent graft is specifically designed to address challenges posed by small, stenotic, and tortuous iliac vessels, making it a promising option for patients with complex vascular anatomies.

Recent real-world use of the Incraft stent graft has shown good mid-term results, suggesting its potential to be a reliable choice in endovascular aneurysm repair (EVAR), although its long-term role in standard practice is still being evaluated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Incraft stent graft for the treatment of abdominal aortic aneurysms: an iliac-friendly device with an effective conventional proximal sealing mechanism. Schoretsanitis, N., Georgakarakos, E., Argyriou, C., et al.[2022]

Transcatheter edge-to-edge repair techniques, like the TriClip and PASCAL Implant System, have been shown to be safe and effective for treating significant tricuspid regurgitation in older patients who are at high surgical risk.

These devices have received CE mark approval based on clinical trials demonstrating their feasibility and efficacy, but further randomized controlled trials are needed to fully assess their impact compared to standard treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Leaflet Strategies for Tricuspid Regurgitation TriClip and CLASP. Vogelhuber, J., Weber, M., Nickenig, G.[2021]

A patient with severe bioprosthetic tricuspid valve stenosis was successfully treated using a novel 29-mm balloon expandable Myval transcatheter heart valve, demonstrating the potential efficacy of this new device.

This case adds to the growing body of evidence supporting transcatheter valve-in-valve procedures for patients with degenerated tricuspid bioprosthetic valves, although further studies are needed to clarify the overall safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Tricuspid Valve-in-Valve Implantation With a Novel Balloon Expandable Myval THV. Duran Karaduman, B., Ayhan, H., Keleş, T., et al.[2021]

The TRICENTO system, a novel transfemoral bicaval valved stent, demonstrated a 100% technical success rate in 21 high-risk patients with severe tricuspid regurgitation, with no in-hospital mortality reported.

Patients showed significant symptomatic improvement, with 65% moving to a better functional class (NYHA class I/II) after a median follow-up of 61 days, alongside evidence of right ventricular reverse remodeling, although some stent fractures were noted that require further design refinement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Clinical Experience With the TRICENTO Bicaval Valved Stent for Treatment of Symptomatic Severe Tricuspid Regurgitation: A Multicenter Registry. Wild, MG., Lubos, E., Cruz-Gonzalez, I., et al.[2022]

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This was a prospective, single-arm, multicenter first-in-human study to evaluate the safety and performance of the Trillium stent graft system.

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pmc.ncbi.nlm.nih.gov/articles/PMC11307702/

The Current Landscape of Transcatheter Tricuspid Valve ...

More recently, 1-year outcomes were presented at PCR London Valves 2022, with 90.1% survival, 88.4% freedom from heart failure hospitalizations, ...

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Innoventric Trillium™ Stent Graft First-in-Human (FIH) St...

A prospective, single-arm, multi-center first-in-human (FIH) study to evaluate the safety and performance of the Innoventric Trillium™ Stent ...

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The rates of 6-month all-cause mortality and heart failure hospitalization were 8.5% and 20%, respectively. Conclusions. The dedicated bicaval system for ...

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The purpose of this study is to assess the safety and performance of the Innoventric Trillium™ Stent Graft System in the treatment of severe ...

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Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

Early Feasibility Study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater ...