What is the mechanism of action of this treatment?

Mitral Valve Stenosis (MVS) treatments aim to improve valve function and hemodynamics. The Foldax Polymer Mitral Valve trial focuses on mitral valve replacement, which involves replacing the damaged valve with a synthetic one to restore normal blood flow and reduce symptoms. Other common treatments include balloon valvuloplasty, which widens the valve opening, and surgical repair, which fixes the existing valve. These treatments are crucial as they improve cardiac output, reduce pulmonary hypertension, and alleviate symptoms, enhancing the quality of life for MVS patients.

What side effects are associated with this type of intervention?

Common treatments for Mitral Valve Stenosis, such as surgical mitral valve replacement or repair, can have several side effects. These include bleeding, infection, blood clots, valve dysfunction, and arrhythmias. Additionally, patients may experience complications related to anesthesia and the surgical procedure itself, such as stroke or heart attack. These treatments aim to improve heart function and hemodynamics, similar to the goals of the Foldax Polymer Mitral Valve being studied.

What prior FDA approvals exist?

The FDA has approved several treatments for Mitral Valve Stenosis, focusing on improving heart function and hemodynamics. One notable device is the MitraClip, which is used for transcatheter mitral valve repair and has shown favorable outcomes in both degenerative and functional mitral regurgitation. This device is particularly beneficial for patients at high surgical risk. Additionally, traditional surgical mitral valve replacement and repair techniques remain standard treatments, aiming to restore proper valve function and improve overall cardiac performance.

What other types of research exist?

Promising alternatives to the Foldax Polymer Mitral Valve for mitral valve stenosis patients include: 1) Transcatheter Mitral Valve Replacement (TMVR) devices such as the Tendyne Mitral Valve System and the Intrepid TMVR System, which offer minimally invasive options for patients who are high-risk for open-heart surgery. 2) MitraClip, a transcatheter mitral valve repair device that has shown success in reducing mitral regurgitation and improving heart function. 3) The PASCAL Transcatheter Valve Repair System, which is another minimally invasive option designed to improve mitral valve function and patient outcomes.

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Polymer Mitral Valve

Foldax TRIA Heart Valve for Mitral Valve Disease (FOLDAX Trial)

N/A

Waitlist Available

Research Sponsored by Foldax, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is a candidate for mitral valve replacement due to moderate to severe mitral valve stenosis, moderate to severe mitral valve regurgitation, or moderate to severe mixed mitral stenosis/regurgitation

Is a candidate for mitral valve replacement with cardiopulmonary bypass

Must not have

Renal or hepatic failure

Hematological disorders, patients must not have a hematocrit of <30%, hemoglobin <10 g/dL, platelet count of <100,000 cells/µL, or WBC <4,000 cells/µL; coagulation profile must not be outside of normal limits

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years following patient enrollment

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, typical risks of heart valve replacement include bleeding, infection risk at the surgical site, potential reactions to anesthesia or anticoagulants used during/after surgery, and possible complications related to heart function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have kidney or liver failure.

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My blood counts are within normal ranges.

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My body was found unsuitable for the device during surgery.

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I need emergency surgery.

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I do not have an ongoing heart infection or inflammation.

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My non-heart related illness may shorten my life to under a year.

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I have had surgery on my mitral valve, but not a procedure like MitraClip.

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I have a condition, like an aortic aneurysm, that increases my surgery risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years following patient enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years following patient enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years following patient enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Effectiveness: Change in New York Heart Association Assessment

Primary Effectiveness Endpoints- Change in Hemodynamic Performance

Primary Safety Endpoints

Secondary study objectives

ICU Duration of Stay

Kansas City Cardiomyopathy Questionnaire (KCCQ)

New Onset Atrial Fibrillation

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TRIA Mitral ValveExperimental Treatment1 Intervention

Patients receiving the Foldax Mitral Valve

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Mitral Valve Stenosis (MVS) treatments aim to improve valve function and hemodynamics. The Foldax Polymer Mitral Valve trial focuses on mitral valve replacement, which involves replacing the damaged valve with a synthetic one to restore normal blood flow and reduce symptoms. Other common treatments include balloon valvuloplasty, which widens the valve opening, and surgical repair, which fixes the existing valve. These treatments are crucial as they improve cardiac output, reduce pulmonary hypertension, and alleviate symptoms, enhancing the quality of life for MVS patients.