TricValve System for Tricuspid Valve Disease

(TRICAV-II Trial)

Not yet recruiting at 15 trial locations

Overseen By Monica Tocchi, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: P+F Products + Features USA Inc.

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Recent MI, Stroke, Severe renal insufficiency, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the TricValve System, designed to assist people with severe tricuspid valve disease. This condition occurs when the valve between the right heart chambers fails to close properly, causing blood to flow backward. The trial will compare the effectiveness of this device used alongside standard heart medications versus using these medications alone. Participants should have experienced severe tricuspid regurgitation and significant heart issues, such as hospitalization for heart failure in the past six months. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could enhance treatment options for severe tricuspid valve disease.

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, you must be on stable optimal medical therapy (OMT) for at least 30 days before joining the trial, which suggests you may need to continue your current medications.

What prior data suggests that the TricValve System is safe for tricuspid valve disease?

Research has shown that the TricValve System, used to treat tricuspid valve disease, is generally safe. In one study, patients who received the TricValve reported significant improvements in their quality of life over a year, with low death rates. Another study examined safety after 30 days and effectiveness after 6 months, finding that the valves were well-tolerated with no major safety issues. These studies suggest that the TricValve System is safe for people, with only mild or moderate side effects noted. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TricValve Transcatheter Bicaval Valve System because it offers a minimally invasive alternative for treating tricuspid valve disease. Unlike traditional surgical options, which often involve open-heart surgery, the TricValve is delivered via a catheter, reducing recovery time and associated risks. Additionally, this system specifically targets the caval veins, potentially improving outcomes for patients with severe tricuspid regurgitation who have limited treatment options. This innovative approach could significantly enhance the quality of life for those who are not ideal candidates for surgery.

What evidence suggests that the TricValve System is effective for tricuspid valve disease?

Research has shown that the TricValve System holds promise for treating severe tricuspid valve disease. One study found that patients using the TricValve experienced a much better quality of life within a year and had relatively low death rates. Another study examined the short-term safety and effectiveness of the TricValve, showing good results at 30 days and 6 months. In this trial, participants may receive the TricValve Device along with Optimal Medical Therapy (OMT), or they may receive OMT alone. The TricValve is a special device that works with the veins leading to the heart without altering the heart's natural valve. It uses valves made from animal tissue, supported by a metal frame, and is inserted through a vein in the leg. Overall, these studies suggest the TricValve could be a helpful option for patients with this condition. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals with severe tricuspid valve disease, specifically those suffering from tricuspid regurgitation. Participants should be experiencing symptoms that significantly impact their daily life or have a high risk of complications from surgery.

Inclusion Criteria

The local Heart Team and IEC determine that the patient is eligible

My heart has a severe valve issue confirmed by an echo test.

I am a woman who can have children and my pregnancy test is negative.

Exclusion Criteria

My kidney function is very low or I am on dialysis.

LVEF ≤ 30% on echocardiography

Pulmonary artery systolic pressure (PASP) >65 mmHg

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the TricValve System with Optimal Medical Therapy or Optimal Medical Therapy alone

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• TricValve Transcatheter Bicaval Valve System

Trial Overview The study tests the TricValve Transcatheter Bicaval Valve System against optimal medical therapy. The system includes two bovine pericardium leaflet valves mounted on self-expanding stents, inserted via veins in the leg to reach and support the heart's tricuspid valve without disturbing it.

How Is the Trial Designed?

Group I: TricValve® Device (Device) + Optimal medical therapy (OMT) Experimental Treatment 2 Interventions

TricValve® Device (Device) + OMT

Group II: TricValve Single Arm Registry Experimental Treatment 2 Interventions

Patients who fulfil any of the screening criteria to participate in a parallel singe-arm registry.

Group III: Optimal medical therapy (OMT) Alone Active Control 1 Intervention

OMT can prevent heart attacks and heart failure with medications like blood thinners, cholesterol drugs, and blood pressure meds.

Who Is Running the Clinical Trial?

P+F Products + Features USA Inc.

Lead Sponsor

Trials

2

Recruited

650+

Meditrial USA Inc.

Industry Sponsor

Trials

8

Recruited

1,900+

Published Research Related to This Trial

In a study of 44 patients with severe tricuspid regurgitation, the TricValve system led to significant clinical improvements in quality of life and functional status for 95.5% of participants after one year.

The procedure was associated with a low mortality rate of 6.8% and effectively reduced symptoms of congestion, with 63.8% of patients experiencing abolished hepatic vein backflow, indicating its potential as a safe treatment option for patients ineligible for open heart surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: One-Year Follow-Up Outcomes. Blasco-Turrión, S., Briedis, K., Estévez-Loureiro, R., et al.[2023]

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]

In a study involving 5 patients with severe tricuspid regurgitation (TR), the novel GATE System for transcatheter tricuspid valve replacement was successfully implanted, leading to a significant reduction in TR severity to ≤2+.

Follow-up results showed that most patients experienced right ventricular remodeling, increased cardiac output, and improved functional status, indicating the potential efficacy of this device in treating severe TR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Single-Site Experience With Transcatheter Tricuspid Valve Replacement. Hahn, RT., George, I., Kodali, SK., et al.[2020]

Transcatheter tricuspid valve-in-valve (TTViV) replacement was performed successfully in 12 high-risk patients, leading to significant improvements in heart function and echocardiographic measures over a mean follow-up of 3.17 years.

The procedure resulted in a notable decrease in transvalvular mean gradient pressure and tricuspid regurgitation gradient, with no significant leakage observed, indicating that TTViV is a safe and effective treatment for patients with degenerated bioprosthetic tricuspid valves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mid to Long-Term Echocardiographic Follow-up of Patients Undergoing Transcatheter Tricuspid Valve-in-Valve Replacement for Degenerated Bioprosthetic Valves: First Single-Center Report from Iran. Sahebjam, M., Haji Zeinali, A., Abbasi, K., et al.[2023]

The transcatheter bicaval valve system is a new treatment option for tricuspid regurgitation, designed to prevent caval reflux using two biological valves.

This report highlights the first documented case of thrombosis associated with this device, indicating potential safety concerns that need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bicaval Transcatheter Prosthesis Implantation for Treatment of Tricuspid Regurgitation: First Report of Thrombosis. Custódio, P., Carvalho, A., Bico, P.[2023]

The Tricento transcatheter heart valve was successfully implanted in a 74-year-old woman with severe tricuspid regurgitation, marking its first use via transvenous transfemoral access.

Three months after the implantation, the patient showed significant clinical improvement and reduced caval vein regurgitant volume, indicating the device's potential as a safe and effective treatment for patients unable to undergo open heart surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-man implantation of the Tricento transcatheter heart valve for the treatment of severe tricuspid regurgitation. Toggweiler, S., De Boeck, B., Brinkert, M., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38069986/

Bicaval TricValve Implantation in Patients With Severe ... Caval valve implantation with the TricValve system associated with meaningful 1-year clinical improvements in terms of QOL along with relatively low mortality ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1936879822009487

6-Month Outcomes of the TricValve System in Patients With ... The aim of this study was to evaluate the 30-day safety and 6-month efficacy outcomes of specifically designed bioprosthetic valves for the superior and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06137807

TRIcvalve biCAVal Valve System for Severe Tricuspid ... This is a prospective multicenter clinical investigation designed to evaluate the safety and effectiveness of the TricValve® Transcatheter Bicaval Valve System.

4. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06137807

TRIcvalve biCAVal Valve System for Severe Tricuspid ... A prospective multicenter clinical investigation designed to evaluate the safety and effectiveness of the TricValve® Transcatheter Bicaval Valve System.

5. jacc.org jacc.org/doi/abs/10.1016/j.jcin.2022.05.022

6-Month Outcomes of the TricValve System in Patients With ... The aim of this study was to evaluate the 30-day safety and 6-month efficacy outcomes of specifically designed bioprosthetic valves for the superior and ...