Transcatheter Valve Intervention for Tricuspid Regurgitation

Overseen By Xiaoxia Song, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jenscare Innovation Inc.

Must be taking: Diuretics

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Low LVEF, Pulmonary hypertension, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

15 Participants Needed

Trial Summary

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

The trial protocol does not specify if you need to stop taking your current medications. However, you must be on an optimal dosage of diuretics as determined by the investigator.

What data supports the effectiveness of the treatment LuX-Valve Plus System for tricuspid regurgitation?

Research shows that the LuX-Valve treatment significantly improved symptoms in patients with severe tricuspid regurgitation, with most patients experiencing reduced valve leakage and better heart function. In a study, 11 out of 12 patients had successful outcomes, and their quality of life improved without major complications. ^{1 2 3 4 5}

Is the LuX-Valve system safe for treating tricuspid regurgitation?

The LuX-Valve system has been shown to be generally safe for treating severe tricuspid regurgitation, with studies reporting successful procedures and significant improvement in patients' symptoms. In a study of 12 patients, there were no device-related complications, and most patients experienced improved quality of life. ^{1 2 3 6 7}

How is the LuX-Valve Plus treatment different from other treatments for tricuspid regurgitation?

The LuX-Valve Plus is unique because it is a transcatheter valve replacement system that does not rely on radial force, making it a promising alternative for patients who are at high risk for open-heart surgery. It is implanted through a minimally invasive approach, which can significantly improve symptoms and quality of life for patients with severe tricuspid regurgitation. ^{1 2 3 5 8}

What is the purpose of this trial?

The LuX-Valve Plus System is intended for the treatment of patients with at least severe TR who are symptomatic and determined by a Heart Team not to be suitable for surgical treatment. This study aims to assess the safety and effectiveness of the LuX-Valve Plus System in high-surgical risk patients with at least severe tricuspid regurgitation (TR).

Eligibility Criteria

This trial is for adults over 18 with severe heart murmur or tricuspid valve regurgitation, who are symptomatic but considered unsuitable for surgery by a Heart Team. They must understand the study and consent to participate, be on stable diuretic medication, and have their condition confirmed by specialized labs.

Inclusion Criteria

My heart valve leak is severe or worse, confirmed by an echo.

My heart condition limits my physical activity.

I understand the study details and can give my written consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the LuX-Valve Plus System for the treatment of severe tricuspid regurgitation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

1 visit (in-person) at 30 days post-procedure

Extended Follow-up

Participants are monitored for long-term safety and effectiveness

1 year

1 visit (in-person) at 1 year post-procedure

Treatment Details

Interventions

• LuX-Valve Plus System

Trial Overview The LuX-Valve Plus System is being tested in this trial. It's a non-surgical procedure designed to replace the tricuspid valve through a vein (transcatheter intervention) in patients at high risk from traditional surgery.

Participant Groups

Group I: : LuX-Valve Plus transvenous tricuspid valve and delivery system(LuX-Valve Plus System) Experimental Treatment 1 Intervention

The LuX-Valve Plus System is intended for the treatment of patients with severe TR who are determined by a Heart Team to be at high risk of traditional open-heart surgery.

LuX-Valve Plus System is already approved in China, United States, European Union for the following indications:

Approved in China as LuX-Valve Plus for:

• Severe tricuspid regurgitation (TR)

Approved in United States as LuX-Valve Plus for:

• Severe tricuspid regurgitation (TR)

Approved in European Union as LuX-Valve Plus for:

• Severe tricuspid regurgitation (TR)

Who Is Running the Clinical Trial?

Jenscare Innovation Inc.

Lead Sponsor

Trials

1

Recruited

20+

Cardiovascular Research Foundation, New York

Collaborator

Trials

28

Recruited

27,800+

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]

In a study involving 12 patients with severe tricuspid regurgitation (TR) who were not candidates for surgery, LuX-Valve implantation was successfully performed in all cases without any intraprocedural mortality, demonstrating its safety and feasibility.

Post-implantation, TR severity significantly improved in 11 out of 12 patients, with most experiencing a reduction to none or trivial levels, and a notable enhancement in quality of life as measured by the New York Heart Association classification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Safety and efficacy of transcatheter tricuspid valve replacement with LuX-Valve in patients with severe tricuspid regurgitation]. Ning, XP., An, Z., Qiao, F., et al.[2021]

In a study of 30 patients with severe symptomatic tricuspid regurgitation, the LuX-Valve transcatheter intervention achieved a 100% surgical success rate, significantly improving cardiac index and stroke volume after the procedure.

The implantation of the LuX-Valve effectively eliminated tricuspid regurgitation, leading to improved hemodynamic profiles without significantly affecting pulmonary artery pressure, indicating its potential as a superior treatment option for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamics of transcatheter tricuspid valve replacement with Lux-Valve. Wei, W., Ning, L., Xiaoping, N., et al.[2022]

Severe tricuspid regurgitation can significantly increase the risk of health complications and organ dysfunction, highlighting the importance of effective treatment options.

New interventional treatments for tricuspid regurgitation are gaining attention, suggesting a shift in focus towards improving outcomes for patients with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcatheter Treatment of Severe Tricuspid Regurgitation]. Winkel, M., Hunziker, L., Pilgrim, T., et al.[2020]

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]

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]

The PASCAL transcatheter valve repair system demonstrated a high procedural success rate of 86% in 28 patients with severe tricuspid regurgitation, indicating its feasibility and safety for high-risk surgical patients.

At 30-day follow-up, 85% of patients had a significant reduction in tricuspid regurgitation severity, and there was a notable improvement in exercise capacity, with six-minute walk distances increasing from 240 m to 335 m.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compassionate Use of the PASCAL Transcatheter Valve Repair System for Severe Tricuspid Regurgitation: A Multicenter, Observational, First-in-Human Experience. Fam, NP., Braun, D., von Bardeleben, RS., et al.[2020]

Severe tricuspid valve regurgitation (TR) has been historically underestimated, particularly in older patients, but new interventional treatments show promising results in reducing TR and improving patient outcomes with a good safety profile.

Current interventional options include coaptation systems, annuloplasty, and valve replacement, with coaptation systems having the most clinical experience and evidence supporting their efficacy; careful patient selection is crucial for successful treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current technologies in interventional treatment of tricuspid valve regurgitation]. Rosch, S., Lurz, P.[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. China pubmed.ncbi.nlm.nih.gov

[Safety and efficacy of transcatheter tricuspid valve replacement with LuX-Valve in patients with severe tricuspid regurgitation]. [2021]

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

Hemodynamics of transcatheter tricuspid valve replacement with Lux-Valve. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

[Transcatheter Treatment of Severe Tricuspid Regurgitation]. [2020]

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. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Compassionate Use of the PASCAL Transcatheter Valve Repair System for Severe Tricuspid Regurgitation: A Multicenter, Observational, First-in-Human Experience. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

[Current technologies in interventional treatment of tricuspid valve regurgitation]. [2021]