Foldax TRIA Heart Valve for Mitral Valve Disease

(FOLDAX Trial)

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

15 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. However, you must be able to handle short-term anticoagulation (blood-thinning medication) as part of the trial.

What data supports the effectiveness of the Foldax TRIA Mitral Valve treatment for Mitral Valve Disease?

The Trifecta valve, a similar type of heart valve, has shown good hemodynamic performance (how well blood flows through the valve) in studies, which suggests that the Foldax TRIA Mitral Valve might also perform well in improving blood flow in patients with mitral valve disease. ^{1 2 3 4 5}

What makes the Foldax TRIA Mitral Valve treatment unique for mitral valve disease?

The Foldax TRIA Mitral Valve is unique because it uses a single polymer material called polyhydroxyalkanoates (PHAs) to create a biodegradable and biocompatible heart valve scaffold, which eliminates the need for suturing and offers superior elasticity and mechanical strength compared to previous materials. ^{1 5 6 7 8}

What is the purpose of this trial?

This trial is testing a new artificial heart valve made from special plastic. It is for patients who need a replacement for their faulty mitral valve. The new valve is implanted through surgery to help the heart work better.

Research Team

Frank Shannon, MD

Principal Investigator

Beaumont Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

Early Midterm Results After Valve Replacement With Contemporary Pericardial Prostheses for Severe Aortic Stenosis. [2021]

2. Japan pubmed.ncbi.nlm.nih.gov

Hemodynamic performance and incidence of patient-prosthesis mismatch of small-sized Trifecta pericardial aortic valves. [2021]

3. Japan pubmed.ncbi.nlm.nih.gov

Early outcomes and hemodynamics after implantation of the Trifecta aortic bioprosthesis. [2021]

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

The new St Jude Trifecta versus Carpentier-Edwards Perimount Magna and Magna Ease aortic bioprosthesis: is there a hemodynamic superiority? [2022]

5. England pubmed.ncbi.nlm.nih.gov

Early results of a new mechanical tri-leaflet heart valve prosthesis--"Tricusp": an animal study. [2019]

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

Fabrication of a trileaflet heart valve scaffold from a polyhydroxyalkanoate biopolyester for use in tissue engineering. [2006]

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

Preclinical hemodynamic assessment of a new trileaflet mechanical valve in the aortic position in a bovine model. [2019]

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

In vivo performance of a tri-leaflet mechanical heart valve prosthesis in an ovine model. [2023]