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

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the Trillium™ Stent Graft treatment for tricuspid regurgitation?

While there is no direct data on the Trillium™ Stent Graft, similar treatments like the TRICENTO bicaval valved stent and the LuX-Valve have shown promising results in treating severe tricuspid regurgitation, improving patient symptoms and heart function. These treatments suggest that using stent grafts for tricuspid regurgitation can be effective and safe. ^{1 2 3 4 5}

How is the Trillium™ Stent Graft treatment for tricuspid regurgitation different from other treatments?

The Trillium™ Stent Graft is unique because it offers a minimally invasive option for treating tricuspid regurgitation by using a stent graft to substitute the tricuspid valve function, unlike traditional open-heart surgery. This approach is similar to other emerging transcatheter interventions, but it specifically targets the tricuspid valve with a novel stent graft design. ^{1 4 5 6 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

4-Year Follow-Up after Transatrial Transcatheter Tricuspid Valve Replacement with the LuX-Valve. [2022]

2. England 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. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Transcatheter Leaflet Strategies for Tricuspid Regurgitation TriClip and CLASP. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Percutaneous caval stent valve implantation: investigation of an interventional approach for treatment of tricuspid regurgitation. [2010]

5. United States pubmed.ncbi.nlm.nih.gov

Early Clinical Experience With the TRICENTO Bicaval Valved Stent for Treatment of Symptomatic Severe Tricuspid Regurgitation: A Multicenter Registry. [2022]

6. Singapore pubmed.ncbi.nlm.nih.gov

A new approach to the interventional therapy of tricuspid regurgitation. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Transcatheter Tricuspid Valve-in-Valve Implantation With a Novel Balloon Expandable Myval THV. [2021]