Transcatheter Tricuspid Valve Replacement for Tricuspid Regurgitation

Recruiting at 3 trial locations

Overseen By Ron Davidson, B. Sc., MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Trisol Medical

Must be taking: Guideline-directed heart failure therapy

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Stroke, Myocardial infarction, Sepsis, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 30

Duration: During procedure

15 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should be adequately treated based on medical standards for certain conditions at least 30 days before the procedure, which might imply continuing some treatments.

How is the Trisol System treatment different from other treatments for tricuspid regurgitation?

The Trisol System is a transcatheter tricuspid valve replacement, which is a minimally invasive procedure that offers an alternative to open-heart surgery for patients with severe tricuspid regurgitation. Unlike traditional surgery, this approach can be performed through a catheter, reducing recovery time and surgical risks, especially for high-risk patients. ^{1 2 3 4 5}

What is the purpose of this trial?

The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).

Research Team

Isaac George, MD

Principal Investigator

Columbia University

Eligibility Criteria

Adults over 18 with moderate to severe tricuspid regurgitation, who are at high risk for surgery and suitable for a non-surgical valve replacement. They must be stable on heart failure medications for at least 30 days, able to give informed consent, follow study procedures, and have the right anatomy for the Trisol system.

Inclusion Criteria

Participant understands the nature of the procedure and provides written informed consent prior to any study specific assessments

I am of legal age to make my own health decisions.

I have moderate or severe symptoms from a heart valve issue, confirmed by an echo test.

Exclusion Criteria

Your blood pressure in the arteries of your lungs is higher than 80 mmHg when measured with a special device.

My veins are not suitable for implant placement.

I am allergic or cannot take blood thinners.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Trisol System device to treat tricuspid regurgitation

During procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Visits at 30 days, 6 months, and 12 months

Long-term follow-up

Participants are monitored annually for changes in NYHA class and quality of life

Annually after 12 months

Treatment Details

Interventions

• Trisol System

Trial Overview The trial is testing the safety and performance of the Trisol system in patients with significant tricuspid valve issues. It's an early feasibility study where participants receive a transcatheter tricuspid valve replacement instead of traditional surgery.

Participant Groups

Group I: Treatment with the Trisol System Experimental Treatment 1 Intervention

Trisol System is already approved in United States, European Union for the following indications:

Approved in United States as Trisol System for:

• Moderate or greater tricuspid regurgitation (TR)

Approved in European Union as Trisol System for:

• Severe tricuspid regurgitation (TR)

Who Is Running the Clinical Trial?

Trisol Medical

Lead Sponsor

Trials

1

Recruited

20+

Findings from Research

Transcatheter tricuspid valve replacement is a viable treatment option for high-risk patients with degenerated tricuspid prostheses, offering an alternative to traditional surgery.

Both transjugular and transfemoral approaches are effective, with the transfemoral method being more commonly used, as demonstrated in a challenging case where a long sheath was utilized for valve delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tough Crossing: A Challenging Case of Valve-in-Valve Transcatheter Tricuspid Valve Replacement. Gupta, T., Lin, CH., Kleiman, NS., et al.[2023]

Tricuspid regurgitation (TR) is common in heart failure patients, and valve replacement is essential for those with irreparable valves or high risk of future failure.

The manuscript outlines a specific technique for tricuspid valve replacement using a bioprosthetic valve, which may improve outcomes for patients with significant TR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tricuspid valve replacement with a bioprosthetic valve. Russell, HM., McCarthy, PM., Lee, R., et al.[2016]

Transcatheter tricuspid valve interventions, particularly replacement, are emerging as promising treatments for severe tricuspid regurgitation, especially in elderly patients where traditional methods have limited efficacy.

These interventions may improve both quality of life and survival rates, making them a potentially preferred option over conventional surgery and repair methods for patients who cannot benefit from repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on Transcatheter Tricuspid Valve Replacement Therapies. Goldberg, YH., Ho, E., Chau, M., et al.[2021]

Transcatheter interventions for severe tricuspid regurgitation are still largely investigational, with the MitraClip being the most commonly used device, showing better effectiveness when the gap between leaflets is less than 7 mm.

The Tricuspid Cardioband has received CE mark approval and shows promising short-term results, highlighting the importance of careful patient selection and assessment of disease severity for successful interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter tricuspid valve intervention: a practical algorithm for patient selection. Ho, EC., Ong, G., Fam, NP.[2020]

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]

References

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

Tough Crossing: A Challenging Case of Valve-in-Valve Transcatheter Tricuspid Valve Replacement. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Tricuspid valve replacement with a bioprosthetic valve. [2016]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Update on Transcatheter Tricuspid Valve Replacement Therapies. [2021]

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

Transcatheter tricuspid valve intervention: a practical algorithm for patient selection. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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