Transcatheter Tricuspid Valve Replacement for Tricuspid Regurgitation

Recruiting at 6 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

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called the Trisol System, a transcatheter valve replacement device, to assess its safety and effectiveness for individuals with moderate or more severe tricuspid regurgitation. This heart valve problem causes blood to flow backward into the heart. The main goal is to gather early insights into the device's performance and safety for those at high risk for traditional surgery. Individuals with symptoms of this valve issue who are considered high-risk for surgery may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity for patients to contribute to groundbreaking research and potentially benefit from an innovative treatment option.

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.

What prior data suggests that the Trisol System is safe for treating tricuspid regurgitation?

Research has shown that transcatheter tricuspid valve replacement, such as the Trisol System, yields promising safety results. One study reported a low in-hospital death rate of about 1.37% and a 30-day death rate of 2.49%, indicating that patients generally tolerate the procedure well. Another study found a high success rate of 93.0%, with most patients experiencing significant improvements without serious side effects. These findings suggest that the Trisol System could be a safe option for treating tricuspid regurgitation, although more data is needed for a complete understanding. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Trisol System is unique because it offers a transcatheter approach to replacing the tricuspid valve, which is less invasive than traditional surgical options. Current treatments for tricuspid regurgitation typically involve open-heart surgery, which can be risky and requires a longer recovery time. Researchers are excited about the Trisol System because it allows for valve replacement without the need for open-heart surgery, potentially reducing recovery times and associated risks. This innovative approach could provide a safer and more efficient alternative for patients who are not ideal candidates for surgery.

What evidence suggests that the Trisol System is effective for tricuspid regurgitation?

Research has shown that the Trisol System, which participants in this trial will receive, is a promising treatment for tricuspid regurgitation (TR), a condition where the heart valve doesn't close properly, causing blood to flow backward. In earlier studies, procedures like the Trisol System, which replace the heart valve without surgery, have been very successful. Specifically, one study found a 94.4% success rate for the device and a 93.0% success rate for the procedure. These results suggest that this treatment can effectively reduce the severity of TR. Initial findings indicate significant improvement in patients' conditions, making it a hopeful option for those dealing with this heart issue. ^{1 3 5 6 7}

Who Is on the Research Team?

Isaac George, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12040945/

Transcatheter tricuspid valve replacement: will it prevail? Transcatheter tricuspid valve replacement (TTVR) has rapidly emerged as a promising alternative, offering the potential for more effective treatment outcomes.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11273873/

Transcatheter Tricuspid Valve Replacement: A Feasible ... The TriCinch system, which is suture-based, achieved an 85% procedural success rate in the PREVENT (Transcatheter Treatment of Tricuspid Valve Regurgitation ...

3. journal-of-cardiology.com journal-of-cardiology.com/article/S0914-5087(24)00060-1/fulltext

Transcatheter tricuspid valve interventions One-year outcomes of the multicenter TRISCEND study showed that the device success was 94.4 %, procedural success 93.0 %, and clinical success ...

4. globalcardiology.info globalcardiology.info/site/article/view/81/186

Advancements in transcatheter tricuspid valve repair and ... With a procedural success rate of 88%, one-year follow-up results showed a significant 70% reduction in TR severity to moderate or less (p<0.001). Furthermore, ...

5. clinicaltrials.cedars-sinai.edu clinicaltrials.cedars-sinai.edu/view/DMS-10809

Early Feasibility Study of the Trisol System Protocol The purpose of this study is to evaluate the safety and effectiveness of the experimental Trisol System (TRISOL Valve System) in people who have tricuspid ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04905017

Study Details | NCT04905017 | Trisol System EFS Study 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 ...

7. structuralheartjournal.org structuralheartjournal.org/article/S2474-8706(25)00313-6/fulltext

Clinical Outcomes Following Transcatheter Tricuspid Valve ... TTVR was associated with low in-hospital (1.37%) and 30-day (2.49%) mortality rates, with significant reduction in tricuspid regurgitation and improvement in ...