Transcatheter Tricuspid Valve Replacement for Tricuspid Regurgitation

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Isaac George, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Approved in 2 Jurisdictions

Trial Summary

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).

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.

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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.

Trial 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

Participant Groups

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.

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Columbia University Medical Center/NYPH New York, NY

University of Virginia Cardiology Charlottesville, VA

Piedmont Heart Institute Atlanta, GA

Main Line Health / Lankenau Institute for Medical Research Wynnewood, PA

Who Is Running the Clinical Trial?

Trisol Medical Lead Sponsor

References

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

Tough Crossing: A Challenging Case of Valve-in-Valve Transcatheter Tricuspid Valve Replacement. [2023] Transcatheter tricuspid valve replacement is a feasible treatment alternative in high-risk patients with degenerated tricuspid prosthesis. Either transjugular or transfemoral approaches are feasible, with the latter being used more commonly. We describe a challenging case of valve-in-valve transcatheter tricuspid valve replacement where we used a long sheath positioned in the right ventricular outflow tract to deliver the transcatheter heart valve.

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

Tricuspid valve replacement with a bioprosthetic valve. [2016] Significant tricuspid regurgitation (TR) is present in many patients with heart failure. Valve replacement is necessary in patients in whom the valve is irreparable or in whom there is a high risk of late failure. The following manuscript and videos describe our approach to tricuspid valve replacement with a bioprosthetic valve.

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

Update on Transcatheter Tricuspid Valve Replacement Therapies. [2021] Severe tricuspid regurgitation is relatively common, especially in the elderly, and portends poor survival. Neither medical therapy nor conventional surgery is efficacious for most patients. In contrast, transcatheter tricuspid valve interventions are showing promise to improve quality of life and mortality. Although there is more clinical experience with transcatheter tricuspid valve repair, there are many patients for which repair is either not possible or cannot optimally reduce the severity of tricuspid regurgitation. Transcatheter tricuspid valve replacement is rapidly emerging and may ultimately become the preferred treatment option. In this review, we discuss transcatheter tricuspid valve replacement, analyze the devices in development and in clinical trials, and highlight the advantages and drawbacks of transcatheter tricuspid valve replacement vs. repair.

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

Transcatheter tricuspid valve intervention: a practical algorithm for patient selection. [2020] Worldwide experience in transcatheter tricuspid valve intervention is increasing as more options become available for the treatment of severe tricuspid regurgitation. These devices can be categorized by their primary mechanism of action, including edge-to-edge leaflet devices, space occupying devices, annuloplasty devices, complete valve replacement and caval valve implantation. This review summarizes the current technologies in use, early clinical results and factors that may affect procedural success.

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

4-Year Follow-Up after Transatrial Transcatheter Tricuspid Valve Replacement with the LuX-Valve. [2022] Tricuspid regurgitation (TR) has become one of the most common valve diseases. Patients with severe TR are often at high surgical mortality risk. Transcatheter tricuspid valve interventions have emerged as a promising alternative to open-heart surgery. The LuX-Valve is a novel radial force-independent transcatheter tricuspid valve replacement system. We presented here the first patient treated for symptomatic TR using the LuX-Valve replacement system in September 2018. Four-year follow-up outcomes suggested that the bioprosthesis was in normal function, with stable hemodynamics (mean transtricuspid gradient 2.55 mmHg) and the patient's clinical symptoms were significantly improved; thus indicating that it is a safe, effective, and satisfactory case of the LuX-Valve application in treating a patient with severe TR.