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

Trial Summary

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 data supports the effectiveness of the treatment VenusP-Valve for Pulmonary Regurgitation?

Research shows that transcatheter pulmonary valve implantation (TPVI), a similar treatment, has been effective in treating right ventricular outflow tract dysfunction in patients with congenital heart disease. This suggests that the VenusP-Valve, which is used in a similar way, may also be effective. ^{1 2 3 4 5}

Is the VenusP-Valve safe for treating pulmonary regurgitation?

The VenusP-Valve has been used safely in patients with pulmonary regurgitation, with studies showing promising midterm outcomes. Additionally, transcatheter pulmonary valve implantation (TPVI), a similar procedure, has been reported as safe, even allowing women to have successful pregnancies after the procedure. ^{1 2 4 6 7}

How does the VenusP-Valve treatment for pulmonary regurgitation differ from other treatments?

The VenusP-Valve treatment is unique because it involves a minimally invasive procedure called Transcatheter Pulmonary Valve Implantation (TPVI), which allows the valve to be placed without open-heart surgery, offering a less invasive option compared to traditional surgical methods. ^{8 9 10 11 12}

What is the purpose of this trial?

A prospective, multi-center, non-randomized interventional study to evaluate the safety and effectiveness of the VenusP-ValveTM System in patients with native right ventricular outflow tract (RVOT) dysfunction. Post procedure, a clinical visit will be scheduled at pre-discharge, 30 days, 6 months, 12 months, and annually thereafter to 10 years. About 60 subjects will be enrolled in this study. Data analysis will be performed after all enrolled subjects complete 6-month follow-up and the primary endpoint analysis report will be submitted to FDA for PMA approval.

Eligibility Criteria

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

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)

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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) 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]

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]

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]

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]

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]

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]

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]

References

1. India 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. [2022]

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

Delivery catheters: Do they truly make a difference in transcatheter pulmonary valve replacement? [2020]

3. Australia 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. [2018]

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

Transcatheter pulmonary valve-in-valve implantation within the expandable Inspiris Resilia® bioprosthetic valve. [2022]

5. Poland pubmed.ncbi.nlm.nih.gov

Transcatheter pulmonary valve implantation in 100 patients: a 10-year single-center experience. [2023]

6. United States 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Pregnancy After Transcatheter Pulmonary Valve Implantation. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Flame spray-pyrolyzed vanadium oxide nanoparticles for lithium battery cathodes. [2009]

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

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

10. England pubmed.ncbi.nlm.nih.gov

Li3V2(PO4)3 encapsulated flexible free-standing nanofabric cathodes for fast charging and long life-cycle lithium-ion batteries. [2016]

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

Two-Step Synthesis of VO2 (M) with Tuned Crystallinity. [2018]

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

Facile Phase Control of Multivalent Vanadium Oxide Thin Films (V2O5 and VO2) by Atomic Layer Deposition and Postdeposition Annealing. [2018]