Foldax TRIA Heart Valve for Mitral Valve Disease

(FOLDAX Trial)

Not currently recruiting at 2 trial locations

Overseen By Carlyn Sander, BS, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Foldax, Inc

Disqualifiers: Prior mitral surgery, Emergency surgery, Endocarditis, Neurological deficit, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new heart valve, the Foldax TRIA Mitral Valve, to determine its safety and effectiveness for individuals with serious mitral valve issues. The goal is to ensure the valve enhances blood flow and heart function. It targets those needing a mitral valve replacement due to significant narrowing or leakage. Participants must tolerate temporary blood-thinning medication and adhere to trial requirements. Those with previous mitral valve surgery or certain other health conditions may not qualify. As an unphased trial, this study offers a chance to contribute to groundbreaking research that could advance future heart valve treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you must be able to handle short-term anticoagulation (blood-thinning medication) as part of the trial.

What prior data suggests that the Foldax TRIA Mitral Valve is safe for treating mitral valve disease?

Research has shown that the Foldax TRIA Mitral Valve is safe, based on past studies. In these studies, no deaths or additional surgeries were needed due to the valve, indicating strong safety. After one year, patients' hearts functioned more efficiently, with the pressure difference across the valve dropping from 9.7 mmHg to 4.5 mmHg. The valve also opened more than 90% wider, improving blood flow.

At six months, patients found daily activities easier, as measured by a heart disease symptom scale. Early results demonstrated that the valve performed well and remained safe over one year. Additionally, 30 days after surgery, the valve's safety and effectiveness matched those of long-established heart valves.

Overall, these results suggest that the Foldax TRIA Mitral Valve is well-tolerated and effective, meeting safety standards for heart valve replacements. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Foldax TRIA Mitral Valve is unique because it uses a special polymer material instead of the traditional metal or animal tissue used in other heart valves. This design aims to reduce the risk of blood clots and the need for lifelong blood thinners, which are common with current valve replacements. Researchers are excited about this treatment because it has the potential to last longer and offer a more durable solution for patients with mitral valve disease, potentially improving quality of life without the trade-offs of existing options.

What evidence suggests that the Foldax TRIA Mitral Valve is effective for mitral valve disease?

Research has shown that the Foldax TRIA Mitral Valve, which participants in this trial will receive, is promising for treating mitral valve disease. In a recent study, patients experienced over a 50% reduction in blood flow resistance, reducing the heart's workload. The valve also improved blood flow by over 90%, greatly enhancing heart function. Additionally, the valve performed consistently well and remained safe over a year. These findings suggest that the Foldax TRIA Mitral Valve could be a good option for people with mitral valve disease. ^{1 2 3 6 7}

Who Is on the Research Team?

Frank Shannon, MD

Principal Investigator

Beaumont Hospital

Are You a Good Fit for This Trial?

This trial is for adults who need a mitral valve replacement due to moderate to severe issues with the valve and can handle short-term anticoagulation. It's not for those who've had previous mitral surgery (except certain percutaneous interventions), have other major surgeries planned within a year, or suffer from conditions like active infections, organ failure, severe recent heart events, blood disorders, or are pregnant.

Inclusion Criteria

I need a mitral valve replacement due to severe issues with my valve.

Willing and able to comply with protocol requirements

I am eligible for heart valve surgery with a heart-lung machine.

Exclusion Criteria

Enrolled in another investigational device or drug study (enrolled patients may not enroll in other studies)

I have kidney or liver failure.

My blood counts are within normal ranges.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo open heart surgery for the implantation of the Foldax Polymer Mitral Valve

1 week

1 visit (in-person)

Post-Procedure Recovery

Participants recover from surgery, including ICU and general ward stay

30 days

Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for TIA, stroke, and valve migration

5 years

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Foldax TRIA Mitral Valve

Trial Overview The Foldax TRIA Mitral Valve is being tested in this study. The goal is to gather initial data on its safety and how well it works as a replacement for damaged mitral valves. Participants will receive the new valve through surgery using cardiopulmonary bypass.

How Is the Trial Designed?

Group I: TRIA Mitral Valve Experimental Treatment 1 Intervention

Patients receiving the Foldax Mitral Valve

Who Is Running the Clinical Trial?

Foldax, Inc

Lead Sponsor

Trials

4

Recruited

180+

Citations

1. foldax.com foldax.com/news/foldax-announces-positive-one-year-data-on-tria-tm-mitral-valve

Foldax Announces Positive One-Year Data on TRIA ... >50% reduction in mean gradient (9.7 mmHg to 4.5 mmHg) and >90% increase in effective orifice area (0.9 cm² to 1.5 cm²), the highest reported in ...

2. jacc.org jacc.org/doi/10.1016/j.jacc.2025.06.017

1-Year Results From a Multicenter Trial of a Polymer ... In this study, the authors sought to report 1-year outcomes in patients undergoing SMVR for MV disease using the Tria Mitral Valve (Foldax).

3. sciencedirect.com sciencedirect.com/science/article/pii/S0735109725068421

1-Year Results From a Multicenter Trial of a Polymer ... In this study, the authors sought to report 1-year outcomes in patients undergoing SMVR for MV disease using the Tria Mitral Valve (Foldax).

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40589299/

1-Year Results From a Multicenter Trial of a Polymer ... The polymer surgical MV demonstrated an acceptable safety profile and maintained stable hemodynamic performance through 1 year in patients ...

5. foldax.com foldax.com/clinical-evidence

Clinical Evidence Explore clinical evidence supporting the TRIA™ Mitral Valve's safety, effectiveness, and durability with low 30-day mortality and strong hemodynamic ...

6. tctmd.com tctmd.com/news/solid-early-surgical-results-polymer-mitral-valve

Solid, Early Surgical Results With Polymer Mitral Valve A novel, robotically-made polymer surgical valve has an “acceptable safety” profile and stable hemodynamics through 1 year of follow-up in younger patients.

7. foldax.com foldax.com/news/foldax-r-reports-positive-clinical-results-for-tria-mitral-surgical-heart-valve-using-novel-lifepolymer-material

Foldax® Reports Positive Clinical Results for TRIA Mitral ... At 30 days following surgery, TRIA demonstrated favorable safety and hemodynamics, consistent with long-established standards for heart valves. The results ...