Transcatheter Valve Intervention for Tricuspid Regurgitation

Not currently recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the LuX-Valve Plus System, a transcatheter valve intervention, for individuals with severe tricuspid regurgitation who cannot undergo traditional heart surgery. The main goal is to determine if this system is safe and effective for high-risk patients. Candidates for this trial include those diagnosed with severe tricuspid regurgitation who experience symptoms like fatigue or shortness of breath and for whom surgery is not recommended. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for those unable to undergo surgery.

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 prior data suggests that the LuX-Valve Plus System is safe for treating tricuspid regurgitation?

Research has shown that the LuX-Valve Plus System is generally safe for patients with severe tricuspid regurgitation (TR). One study found that using this system for valve replacement was both feasible and safe, with patients experiencing low rates of death from any cause. Another study, TRAVEL II, demonstrated that the LuX-Valve Plus had low rates of serious side effects within a year, making it a promising option for those unable to undergo traditional surgery. Additionally, results from high-risk patients 30 days after the procedure indicated safety with few complications. Overall, these findings suggest the LuX-Valve Plus is well-tolerated in similar patient groups. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LuX-Valve Plus System because it offers a minimally invasive alternative to traditional open-heart surgery for patients with severe tricuspid regurgitation (TR). Unlike standard treatments that often involve high-risk surgery, this system uses a transvenous approach, meaning it is delivered through the veins, which can significantly reduce recovery time and surgical risks. Additionally, the LuX-Valve Plus System is specifically designed for patients deemed high-risk for surgery, providing a promising option for those who might otherwise have limited treatment choices.

What evidence suggests that the LuX-Valve Plus System is effective for tricuspid regurgitation?

Research has shown that the LuX-Valve Plus System, which participants in this trial will receive, can effectively reduce tricuspid regurgitation (TR), a condition where the heart's tricuspid valve leaks. In one study, patients who received the LuX-Valve Plus experienced less TR after one year and showed significant improvements in right heart function. Another study confirmed the system's safety and effectiveness, with few complications after one year. These findings suggest that the LuX-Valve Plus System may offer a promising, less invasive alternative to traditional open-heart surgery for those with severe TR. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05436028

A Study to Evaluate the Safety and Performance of LuX ... Treatment with the LuX-Valve Plus system may enable patients with tricuspid regurgitation to have a complete tricuspid valve replacement with a minimally ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1936879825000068

Transcatheter Tricuspid Valve Replacement With the Novel ... The 1-year outcomes of the TRAVEL study showed a sustained reduction in TR among patients who underwent LuX-Valve TTVR, accompanied by significant right heart ...

3. citoday.com citoday.com/news/jenscares-lux-valve-plus-evaluated-in-1-year-travel-ii-study-data

Jenscare's Lux-Valve Plus Evaluated in 1-Year TRAVEL II ... The multicenter, TRAVEL II study showed that Lux-Valve Plus system is safe and effective in achieving short delivery times, low 1-year composite event rates.

4. tctmd.com tctmd.com/news/lux-valve-ttvr-device-provides-favorable-1-year-results

LuX-Valve TTVR Device Provides Favorable 1-Year Results One-year follow-up data suggest that a novel transcatheter tricuspid valve replacement (TTVR) device may provide another potential alternative ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12550580/

Clinical Outcomes Following Transcatheter Tricuspid Valve ... The LuX valve demonstrated the highest in-hospital mortality compared to THV systems at 3.43% (95% CI: 0.37%–8.34%), likely influenced by its transapical ...

6. eurointervention.pcronline.com eurointervention.pcronline.com/article/twelve-month-outcomes-of-the-lux-valve-for-transcatheter-treatment-of-severe-tricuspid-regurgitation

Twelve-month outcomes of the LuX-Valve for transcatheter ... Conclusions: Transcatheter tricuspid valve replacement with the LuX-Valve was feasible and safe for patients with severe functional tricuspid regurgitation.

7. structuralheartjournal.org structuralheartjournal.org/article/S2474-8706(25)00090-9/fulltext

30-Day TRINITY Trial Outcomes in Large-Anatomies ... This report presents 30-day clinical outcomes of the novel LuX-Valve Plus transjugular tricuspid valve replacement system in high-surgical-risk patients with ...