New Valve Surgery for Heart Valve Defects

(MVEFS Trial)

Recruiting at 5 trial locations

Overseen By Doug Bernstein, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: PECA Labs

Must not be taking: Antibiotics, Anticoagulants

Disqualifiers: Prosthetic heart valve, Pacemaker, Infection, Anemia, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 week

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a known hypersensitivity to anticoagulants and antiplatelet drugs, you may not be eligible to participate.

What data supports the effectiveness of the MASA Valve, Polymeric Pulmonary Valve treatment for heart valve defects?

Research on similar polymeric pulmonary valves shows they can be more durable and resistant to calcification, which means they might last longer and need fewer replacements. Additionally, replacing pulmonary valves has been shown to improve heart function in patients with certain heart defects. ^{1 2 3 4 5}

What makes the MASA Valve treatment unique for heart valve defects?

The MASA Valve is unique because it is made from flexible synthetic materials, combining the benefits of biological valves' natural blood flow with the durability of mechanical valves, offering a potentially longer-lasting solution for heart valve defects. ^{1 2 6 7 8}

What is the purpose of this trial?

This trial is testing the MASA Valve, a special tube with a valve, in young patients with specific heart defects. The valve helps create a new path for blood to flow from the heart to the lungs and prevents backflow. The goal is to see if this device is safe and beneficial for these patients.

Research Team

David Morales, MD

Principal Investigator

Cinncinnati Childrens Hospital

Eligibility Criteria

This trial is for children and young adults under 22 with certain heart conditions needing surgery to fix blood flow from the right ventricle to the pulmonary artery. They must be able to return for follow-ups, have a legal guardian's consent, and not be involved in other drug/device trials or have severe non-cardiac diseases.

Inclusion Criteria

The patient, and the patient's parent / legal representative where appropriate, and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with clinical investigation plan required follow-up visits

Patient is geographically stable and willing to return for 1 year follow-up for the trial

I am younger than 22 years old.

Exclusion Criteria

You have a pacemaker or mechanical heart valve implanted in the past.

Your white blood cell count is too low, based on a test from your local lab.

You have a prosthetic heart valve in place.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo implantation with the MASA Valve for Right Ventricular Outflow Tract Reconstruction

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for pulmonary regurgitation and other device-related outcomes

1 year

Regular visits (in-person and virtual) over 1 year

Treatment Details

Interventions

• MASA Valve

Trial Overview The MASA Valve Early Feasibility Study tests a new device called MASA Valve in patients requiring surgical reconstruction of the pathway from the heart's right ventricle to the lung arteries (RVOTR). It aims to assess safety and potential benefits as preliminary research before larger studies.

Participant Groups

Group I: Experimental Arm Experimental Treatment 1 Intervention

This is a single-arm study. All participants in this study will undergo implantation with MASA Valve.

MASA Valve is already approved in United States for the following indications:

Approved in United States as MASA Valve for:

• Right Ventricular Outflow Tract Reconstruction (RVOTR)

Who Is Running the Clinical Trial?

PECA Labs

Lead Sponsor

Trials

1

Recruited

10+

Findings from Research

In a case study of an adolescent patient, partial reconstruction of the pulmonary valve using an allograft for the underdeveloped anterior leaflet resulted in significant improvement, with the Z-score of the pulmonary annulus changing from -3.9 to +0.8 after the procedure.

The one-year follow-up showed excellent function of the reconstructed pulmonary valve, suggesting that partial replacement may offer better durability and growth potential compared to complete valve replacement in patients with congenital heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary valve reconstruction by allograft replacement of underdeveloped anterior leaflet in case of late combined pulmonary restenosis after early primary repair. Malyshev, M., Safuanov, A., Malyshev, A., et al.[2021]

The PIZZA valve, a prototype polymeric heart valve made from flexible silicone leaflets and a foldable metal base, showed improved performance after structural modifications, including a shift to a cone shape and overlapping leaflets.

These modifications significantly reduced regurgitation and systolic pressure gradients, indicating that the PIZZA valve could be a promising option for transcatheter implantation in heart valve replacement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Further Evolution of a New Nonbiological Transcatheter Valvular Prosthesis. Schröter, F., Hartrumpf, M., Kuehnel, RU., et al.[2021]

In a study involving 17 pediatric patients, a novel expanded polytetrafluoroethylene-based pulmonary valved conduit showed no mortality and 100% freedom from device-related reinterventions, indicating its safety and potential for long-term use.

The conduit demonstrated favorable right ventricular remodeling after 6 months, with significant reductions in right ventricular end-diastolic volume and no evidence of complications such as thrombus, calcification, or worsening valvular insufficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Results With a Novel Expanded Polytetrafluoroethylene-based Pulmonary Valved Conduit. Baird, CW., Chávez, M., Backer, CL., et al.[2022]

In a study involving 26 patients with a median age of 9.8 years, the expanded polytetrafluoroethylene (ePTFE) valved conduit (VC) showed promising results with no postoperative deaths and no reoperations required for the valve itself over a mean follow-up of 2.6 years.

The ePTFE VC demonstrated superior medium-term performance compared to traditional pulmonary valve replacement options, with 92% of patients experiencing mild or less pulmonary insufficiency and only one case of reintervention for stenosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medium-Term Outcomes After Implantation of Expanded Polytetrafluoroethylene Valved Conduit. Ootaki, Y., Welch, AS., Walsh, MJ., et al.[2019]

In a study of 38 adult patients who underwent pulmonary valve replacement, there was a statistically significant increase in left ventricular ejection fraction by an average of 0.07, indicating improved heart function after the procedure.

For patients with preoperative ejection fractions below 0.50, the improvement was even more pronounced, with an average increase of 0.10, suggesting that pulmonary valve replacement can effectively enhance left ventricular function in those with severe pulmonary insufficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left ventricular function improves after pulmonary valve replacement in patients with previous right ventricular outflow tract reconstruction and biventricular dysfunction. Kane, C., Kogon, B., Pernetz, M., et al.[2021]

The study successfully created 3-leaflet, valved pulmonary conduits using autologous ovine vascular cells and biodegradable polymers, demonstrating their ability to function in the pulmonary circulation without thrombus formation for up to 24 weeks.

Histological and biochemical analyses showed that the seeded constructs developed organized and viable tissue with increasing cellular and extracellular matrix content, indicating ongoing remodeling and adaptation of the tissue-engineered valves over at least 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tissue-engineered valved conduits in the pulmonary circulation. Stock, UA., Nagashima, M., Khalil, PN., et al.[2019]

A 6-year-old boy with pulmonary regurgitation after congenital heart disease repair successfully underwent a novel surgical technique for pulmonary valve replacement.

The use of expanded polytetrafluoroethylene membrane for trileaflet pulmonary valve reconstruction is a safe and effective option for young children who cannot receive larger bioprosthetic valves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trileaflet pulmonary valve reconstruction for pulmonary regurgitation in childhood. Ishimaru, K., Kanaya, T., Sakamoto, S., et al.[2019]

The TIPI 3.4 valve prototype demonstrated improved hemodynamic performance compared to its predecessor and was comparable to existing biological and mechanical valves, showing lower regurgitation and favorable pressure gradients.

By eliminating the central restrictor structure, the TIPI valve reduces potential thrombogenicity and increases the effective opening area, making it a promising candidate for 3D printing and mass production of polymeric heart valves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress on a Novel, 3D-Printable Heart Valve Prosthesis. Schröter, F., Kühnel, RU., Hartrumpf, M., et al.[2023]

References

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

Pulmonary valve reconstruction by allograft replacement of underdeveloped anterior leaflet in case of late combined pulmonary restenosis after early primary repair. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Further Evolution of a New Nonbiological Transcatheter Valvular Prosthesis. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Preliminary Results With a Novel Expanded Polytetrafluoroethylene-based Pulmonary Valved Conduit. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Medium-Term Outcomes After Implantation of Expanded Polytetrafluoroethylene Valved Conduit. [2019]

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

Left ventricular function improves after pulmonary valve replacement in patients with previous right ventricular outflow tract reconstruction and biventricular dysfunction. [2021]

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

Tissue-engineered valved conduits in the pulmonary circulation. [2019]

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

Trileaflet pulmonary valve reconstruction for pulmonary regurgitation in childhood. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Progress on a Novel, 3D-Printable Heart Valve Prosthesis. [2023]