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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and potential benefits of a new device called the MASA Valve, or Polymeric Pulmonary Valve, for individuals requiring surgery to address pulmonary valve issues. It targets those with conditions such as a high pressure difference across the valve, significant valve leakage, or a need for valve replacement. Participants must be under 22 years old and able to attend follow-up appointments for a year after the procedure. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future heart valve treatments.

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 prior data suggests that the MASA Valve is safe for heart valve surgery?

Research has shown that the MASA Valve is designed for individuals requiring heart valve surgery, particularly to address issues on the right side of the heart. Early studies suggest that patients up to 22 years old tolerate the valve well. This is an early feasibility study, one of the first instances of testing the valve in people to assess its safety and effectiveness. Although specific safety data is not yet available, the trial's progression indicates no major safety concerns at this stage. However, further studies are necessary to fully understand the safety of the MASA Valve. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MASA Valve for heart valve defects because it represents a potentially groundbreaking advancement in valve replacement technology. Unlike traditional mechanical or bioprosthetic valves, the MASA Valve promises a more durable and less invasive solution. Current valve replacement options often require open-heart surgery and long recovery times, but the MASA Valve can be implanted using minimally invasive techniques, which could significantly reduce recovery time and associated risks. This innovation not only improves patient outcomes but also enhances the overall quality of life for those with heart valve defects.

What evidence suggests that the MASA Valve is effective for heart valve defects?

Research has shown that the MASA Valve could enhance heart function in patients requiring surgery on the right side of the heart. In a study with 38 adult patients who underwent a similar valve replacement, heart performance improved significantly. Early results from patients with the MASA Valve are promising, indicating the valve functions well shortly after surgery. Additionally, valves like the MASA Valve, crafted from special materials, are known for their durability and compatibility with the body, potentially reducing complications over time. If successful, the MASA Valve could significantly advance treatment for heart defects, particularly in children. ^{1 2 5 6 7}

Who Is on the Research Team?

David Morales, MD

Principal Investigator

Cinncinnati Childrens Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. dicardiology.com dicardiology.com/content/peca-labs-achieves-successful-first-human-implant-masa-valve-pediatric-pulmonary-valved

PECA Labs Achieves Successful First-In-Human Implant of ... The patient showed encouraging early results from the MASA Valve implantation, with promising valve functionality on early assessment.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590006424002552

Recent advancements in polymeric heart valves The polymeric heart valves (PHVs) have shown a bright future due to their advantages of longer durability, better biocompatibility and reduced cost.

3. withpower.com withpower.com/trial/phase-pulmonary-valve-stenosis-6-2022-0105a

New Valve Surgery for Heart Valve Defects (MVEFS Trial) In a study of 38 adult patients who underwent pulmonary valve replacement, there was a statistically significant increase in left ventricular ejection fraction ...

4. cardiovascularbusiness.com cardiovascularbusiness.com/topics/clinical/structural-heart-disease/new-polymeric-heart-valve-designed-grow-pediatric-patients-implanted-first-time

New polymeric heart valve, designed to grow with pediatric ... If the study is successful, the MASA Valve could offer a significant improvement in the treatment of cardiovascular congenital heart defects in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12090228/

Addressing Global Gaps in Rheumatic Heart Disease Care? Valve replacement with bioprosthetic or mechanical valves is effective but carries the disadvantages of structural valve deterioration and ...

6. jacc.org jacc.org/doi/10.1016/j.jacadv.2025.101761

Addressing Global Gaps in Rheumatic Heart Disease Care? Valve replacement with bioprosthetic or mechanical valves is effective but carries the disadvantages of structural valve deterioration and ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05452720/masa-valve-early-feasibility-study

MASA Valve Early Feasibility Study The objective of the trial is to evaluate the safety and probable benefit of MASA Valve in the indicated subset of patients requiring Right ...