VenusP-Valve for Pulmonary Regurgitation

(PROTEUS Trial)

Overseen By Cong Ma

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Venus MedTech (HangZhou) Inc.

Must not be taking: Antiplatelet, Antithrombotic

Disqualifiers: Infection, Intracardiac mass, Drug abuse, others

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

Compensation: Varies

Number of Visits: 4

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new heart valve treatment, the VenusP-Valve, for individuals with severe pulmonary regurgitation. Pulmonary regurgitation occurs when a leaky valve causes blood to flow backward into the heart, leading to symptoms like shortness of breath and fatigue. The trial aims to determine if transcatheter pulmonary valve implantation (TPVI) is safe and effective for those with a specific heart condition affecting blood flow. This treatment may suit individuals diagnosed with severe pulmonary valve leakage without serious valve narrowing. Participants will undergo regular follow-ups for up to 10 years to monitor outcomes. As an unphased trial, this study offers a unique chance to contribute to groundbreaking research and potentially benefit from an innovative treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the VenusP-ValveTM System is safe for patients with RVOT dysfunction?

Research shows that the VenusP-Valve, used in transcatheter pulmonary valve implantation (TPVI), is generally safe. In studies with patients suffering from severe pulmonary regurgitation, the VenusP-Valve was used without major complications. Specifically, one study found that 86% of patients did not experience serious problems over an average of 5.5 years, suggesting the procedure is usually well-tolerated. Other studies also support the VenusP-Valve's safety and effectiveness for midterm outcomes. Overall, the available evidence indicates that the VenusP-Valve is safe for treating issues in the right ventricular outflow tract. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The VenusP-ValveTM System is unique because it offers a minimally invasive solution for pulmonary regurgitation through transcatheter pulmonary valve implantation (TPVI). Unlike traditional surgical valve replacement, which requires open-heart surgery, TPVI can be performed via a catheter, reducing recovery time and potential complications. Researchers are excited about this treatment because it provides a less invasive alternative with the potential for quicker recovery and fewer risks, opening up options for patients who might not be candidates for surgery.

What evidence suggests that the VenusP-ValveTM System is effective for pulmonary regurgitation?

Research has shown that the VenusP-ValveTM System effectively treats problems in the heart's right ventricular outflow tract (RVOT). This trial will assess the VenusP-ValveTM System's effectiveness in reducing backward blood flow into the heart and improving heart function by placing a valve without surgery. One study found that all patients avoided needing another procedure within the first year, and the treatment remained successful over a longer period. The VenusP-Valve has also been used safely in patients, demonstrating good results even in the medium term. Overall, the VenusP-Valve is a safe and effective treatment option for people with RVOT issues. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals at least 12 years old, weighing over 55 lbs, with pulmonary valve or regurgitation issues. They should have mild to moderate heart dysfunction and a noticeable decrease in exercise tolerance. Participants must commit to follow-up visits for up to 10 years.

Inclusion Criteria

I weigh at least 55 pounds.

My heart's pumping strength is slightly or moderately reduced.

You demonstrate a decreasing capacity for physical activity, are willing to agree to the study terms and will follow through with any post-study evaluations.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo the VenusP-ValveTM System procedure for RVOT dysfunction

During the procedure

1 visit (in-person)

Initial Follow-up

Participants are monitored for safety and effectiveness at pre-discharge, 30 days, and 6 months post-procedure

6 months

3 visits (in-person)

Extended Follow-up

Participants are monitored annually for safety and effectiveness up to 10 years post-procedure

10 years

Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transcatheter pulmonary valve implantation (TPVI)
• VenusP-ValveTM System

Trial Overview The study tests the VenusP-ValveTM System's safety and effectiveness in patients with native right ventricular outflow tract (RVOT) dysfunction through a procedure called transcatheter pulmonary valve implantation (TPVI).

How Is the Trial Designed?

Group I: TPVI Experimental Treatment 2 Interventions

Transcatheter pulmonary valve implantation (TPVI) is already approved in European Union, China, United States for the following indications:

Approved in European Union as VenusP-Valve for:

• Right ventricular outflow tract (RVOT) dysfunction
• Pulmonary regurgitation

Approved in China as VenusP-Valve for:

• Right ventricular outflow tract (RVOT) dysfunction
• Pulmonary regurgitation

Approved in United States as VenusP-Valve for:

• Compassionate use for severe pulmonary regurgitation and RVOT dysfunction

Who Is Running the Clinical Trial?

Venus MedTech (HangZhou) Inc.

Lead Sponsor

Trials

7

Recruited

1,100+

Published Research Related to This Trial

This report presents the first known case of transcatheter pulmonary valve implantation (TPVI) using the Inspiris Resilia® bioprosthetic valve, which features a specially designed balloon-expandable valve ring for better implantation.

The use of the VFit zone in the Inspiris Resilia® valve may enhance the success of TPVI by providing a more suitable area for valve placement in patients with repaired congenital heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter pulmonary valve-in-valve implantation within the expandable Inspiris Resilia® bioprosthetic valve. Batlivala, SP., Hagel, JA., Hirsch, R., et al.[2022]

Transcatheter pulmonary valve implantation (TPVI) is a promising treatment for young patients with pulmonary regurgitation or stenosis, offering a less invasive alternative to traditional conduit replacement.

The study of 4 young women who successfully underwent TPVI and later had pregnancies indicates that with proper precautions, pregnancy and delivery are safe after this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy After Transcatheter Pulmonary Valve Implantation. Kozicka, U., Weroński, K., Rużyłło, W., et al.[2018]

Transcatheter pulmonary valve implantation (TPVI) demonstrated a high initial success rate of 93% in 100 patients, with significant improvements in pulmonary gradient and right ventricular function, indicating its efficacy for treating RVOT dysfunction after congenital heart defect repair.

The long-term safety profile of TPVI is promising, with 86% of patients free from serious adverse events over an average of 5.5 years, although careful patient selection and infection prevention strategies are crucial to minimize risks like infective endocarditis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter pulmonary valve implantation in 100 patients: a 10-year single-center experience. Rużyłło, W., Biernacka, EK., Woźniak, O., et al.[2023]

Monoclinic lithium vanadium phosphate nanoparticles embedded in carbon nanofibers were developed as cathodes for lithium-ion batteries, showing high capacity (128 mA h g(-1) at 0.5 C) and excellent long-term stability (98.9% capacity retention after 500 cycles at 5 C).

The carbon coating on the nanofibers significantly enhanced the electrochemical performance by protecting the structure during charge/discharge cycles and preventing side reactions with the electrolyte, leading to improved rate capability and stability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Li3V2(PO4)3 encapsulated flexible free-standing nanofabric cathodes for fast charging and long life-cycle lithium-ion batteries. Sun, P., Zhao, X., Chen, R., et al.[2016]

Atomic layer deposition of VOx thin films using vanadyl tri-isopropoxide and water at 135 °C resulted in amorphous films, which can be transformed into crystalline phases through postdeposition annealing in different atmospheres.

The study demonstrated that VO2 and V2O5 can be selectively formed by controlling the annealing atmosphere, leading to distinct electrochemical properties and a voltage-induced insulator-to-metal transition in devices made with these materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facile Phase Control of Multivalent Vanadium Oxide Thin Films (V2O5 and VO2) by Atomic Layer Deposition and Postdeposition Annealing. Song, GY., Oh, C., Sinha, S., et al.[2018]

Transcatheter pulmonary valve replacement (TPVR) is a safe and effective procedure for addressing conditions like pulmonary stenosis and failed right ventricular conduits, indicating its reliability in treating complex heart issues.

The use of specific prosthetic valves, such as the Medtronic Melody valve and Edwards Sapien XT and S3 valves, along with the GORE DrySeal sheath, enhances the delivery and overall success of the TPVR procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery catheters: Do they truly make a difference in transcatheter pulmonary valve replacement? Shatila, W., Krajcer, Z.[2020]

Transcatheter pulmonary valve implantation (TPVI) using the MyVal valve was successfully performed in 7 patients with previously implanted dysfunctional conduits, showing significant improvement in conduit diameter and pressure gradient after the procedure.

At a median follow-up of 16 months, all patients remained asymptomatic with no valve-related adverse events, indicating promising mid-term safety and efficacy of the MyVal valve in this setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early multicenter experience of a new balloon expandable MyVal transcatheter heart valve in dysfunctional stenosed right ventricular outflow tract conduits. Sivaprakasam, MC., Reddy, JRV., Gunasekaran, S., et al.[2022]

In a study of 55 patients who underwent percutaneous pulmonary valve implantation (PPVI) with the Venus P-valve system, 96% experienced freedom from all-cause mortality and 98% from reintervention over a 5-year period, indicating high efficacy and safety of the procedure.

Significant improvements were observed in right ventricular diameter and left ventricular ejection fraction (LVEF), along with enhanced functional capacity, demonstrating sustained symptomatic and hemodynamic benefits following the implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year follow-up after percutaneous pulmonary valve implantation using the Venus P-valve system for patients with pulmonary regurgitation and an enlarged native right ventricular outflow tract. Jin, Q., Long, Y., Zhang, G., et al.[2023]

In a study of 17 patients with right ventricular outflow tract dysfunction treated with the Melody transcatheter pulmonary valve, the procedure was successful in all cases, significantly reducing the peak RVOT gradient and showing no significant regurgitation post-implantation.

The study demonstrated the safety of the procedure, with only one major procedural adverse event and no patient deaths, confirming that TPVI with Melody TPV is an effective treatment for patients with repaired congenital heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes Following Melody Transcatheter Pulmonary Valve Implantation for Right Ventricular Outflow Tract Dysfunction in Repaired Congenital Heart Disease: First Reported Australian Single Centre Experience. Markham, R., Challa, A., Kyranis, S., et al.[2018]

Vanadium pentoxide (V2O5) nanoparticles, created using a scalable flame spray pyrolysis process, demonstrated enhanced electrochemical performance due to optimized processing conditions, leading to improved cycle life.

These nanoparticles maintained a specific charge of 110 mAh g(-1) after over 100 cycles and showed excellent performance even at high discharge rates, indicating their potential for use in long-lasting energy storage applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flame spray-pyrolyzed vanadium oxide nanoparticles for lithium battery cathodes. Ng, SH., Patey, TJ., Büchel, R., et al.[2009]

The compound tris-sodium divanadium(III) tris-(orthophosphate) was successfully synthesized and characterized, revealing its structure as part of the NASICON family, which is important for various applications in materials science.

The crystal structure consists of isolated [VO(6)] octahedra and [PO(4)] tetrahedra, with sodium ions occupying different coordination environments, which may influence the compound's properties and potential uses in energy storage or catalysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NASICON-type Na(3)V(2)(PO(4))(3). Zatovsky, IV.[2021]

A two-step thermal treatment successfully synthesizes highly crystallized monoclinic vanadium dioxide (VO2), improving its crystallinity and enhancing its metal-insulator transition properties.

The process involves thermolysis of vanadyl ethylene glycolate followed by postannealing, which increases the crystallite size and the weight percent of crystalline VO2 from 44% to 100%, demonstrating the importance of residual carbon content in achieving optimal crystallization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-Step Synthesis of VO2 (M) with Tuned Crystallinity. Guan, S., Rougier, A., Viraphong, O., et al.[2018]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1936879825005096?via%3Dihub

Transcatheter Pulmonary Valve Implantation Using Self- ... This CE study reports the results of VenusP-valve implantation during 3-year follow-up in patients with severe PR after previous repair of RVOT.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7863798/

Transcatheter pulmonary valve implantation in 100 patients Freedom from reintervention was 100% in 1 year and from serious adverse events 86% in mean 5.5 years of observation. TPVI is a safe and effective method of ...

3. eurointervention.pcronline.com eurointervention.pcronline.com/article/medium-term-results-of-percutaneous-pulmonary-valve-implantation-using-the-venus-p-valve-international-experience

Medium-term results of percutaneous pulmonary valve ... The cohort demonstrated a statistically significant reduction in pulmonary regurgitation fraction and indexed right ventricular diastolic volumes at six and 12 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167527322016527

Long-term outcomes of transcatheter pulmonary valve ... Transcatheter pulmonary valve implantation is effective for treating right ventricular outflow tract dysfunction in patients with congenital heart diseases.

5. withpower.com withpower.com/trial/venusp-valve-for-pulmonary-regurgitation-00614

VenusP-Valve for Pulmonary Regurgitation (PROTEUS Trial) The VenusP-Valve has been used safely in patients with pulmonary regurgitation, with studies showing promising midterm outcomes. Additionally, transcatheter ...

6. jacc.org jacc.org/doi/abs/10.1016/j.jcin.2024.12.031

Transcatheter Pulmonary Valve Implantation Using Self ... We report the 3-year CE study results of percutaneous pulmonary valve implantation in patients with severe pulmonary regurgitation.

7. medicalpolicy.bcbstx.com medicalpolicy.bcbstx.com/content/dam/bcbs/medicalpolicy/pdf/surgery/SUR707.029_2024-12-15.pdf

Transcatheter Pulmonary Valve Implantation Summary of Safety and Effectiveness Data: Melody™. Transcatheter Pulmonary Valve (2015). Available at <https://www.accessdata.fda.gov>.