TricValve System for Tricuspid Valve Disease

(TRICAV-II Trial)

Recruiting at 14 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

600 Participants Needed

Trial Summary

What is the purpose of this trial?

The Investigational Device is the TricValve Transcatheter Bicaval Valve System (also referred to as the TricValve System). The bioprosthesis is available in two different diameters for each model (SVC and IVC) specifically designed to adapt to the anatomic features of the superior vena cava (SVC) and inferior vena cava (IVC). The SVC and IVC valves are single use, sterile devices provided in two sizes each, for a total of four valve sizes. The valves are designed for heterotopic caval implantation without perturbing the native tricuspid valve. The valves are made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system. The SVC and IVC valves are provided pre-mounted in two separate TricValve Delivery Systems, and are individually packaged into two separate boxes, provided sterile and ready to use. The two TricValve Delivery Systems deliver the two valves percutaneously into the SVC and IVC via femoral vein access using a transvenous approach.

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 data supports the effectiveness of the TricValve Transcatheter Bicaval Valve System treatment for tricuspid valve disease?

The TricValve system has shown promise in treating severe tricuspid regurgitation (a condition where the heart's tricuspid valve doesn't close tightly, causing blood to flow backward) in patients who are not candidates for open heart surgery. Studies have reported successful implantation and improvement in symptoms, with one study noting reduced backward blood flow and clinical improvement three months after the procedure. ^{1 2 3 4 5}

Is the TricValve System safe for humans?

The TricValve System, used for treating severe tricuspid regurgitation (a condition where the heart's tricuspid valve doesn't close tightly), has been described as a safe option for high-risk patients, although there has been a report of thrombosis (blood clot) in one case. It is considered a promising treatment for those who cannot undergo open heart surgery, but the experience with this device is still limited. ^{1 2 3 6 7}

How is the TricValve Transcatheter Bicaval Valve System treatment different from other treatments for tricuspid valve disease?

The TricValve Transcatheter Bicaval Valve System is unique because it is designed for patients with severe tricuspid regurgitation who are not suitable for surgery. It involves placing two biological valves through a vein in the leg, which helps prevent blood from flowing backward into the veins, offering a less invasive option compared to traditional surgery. ^{1 2 3 4 6}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Bicaval Transcatheter Prosthesis Implantation for Treatment of Tricuspid Regurgitation: First Report of Thrombosis. [2023]

2. 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]

3. France pubmed.ncbi.nlm.nih.gov

First-in-man implantation of the Tricento transcatheter heart valve for the treatment of severe tricuspid regurgitation. [2019]

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

Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: One-Year Follow-Up Outcomes. [2023]

5. Iran 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Heterotopic caval valve-in-valve procedure for prosthetic migration: two case reports. [2023]

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

Early Single-Site Experience With Transcatheter Tricuspid Valve Replacement. [2020]