What side effects are associated with this type of intervention?

Common treatments for Aortic Valve Disease, particularly mechanical valve replacements like the Foldax Polymer Aortic Valve, are associated with several side effects. These include the risk of thromboembolism, requiring lifelong anticoagulation therapy, which increases the risk of bleeding. Other potential complications include valve malfunction or structural deterioration, infection (endocarditis), and surgical risks such as stroke, myocardial infarction, and wound healing issues.

What prior FDA approvals exist?

The FDA has approved several mechanical and bioprosthetic aortic valve replacement devices for the treatment of aortic valve disease. Notable among these are the Edwards Sapien 3 and the Medtronic CoreValve, which are transcatheter aortic valve replacement (TAVR) devices designed to improve hemodynamic performance. These devices have been shown to be effective in patients with severe aortic stenosis who are at high or intermediate risk for open-heart surgery. The Foldax Polymer Aortic Valve, currently under investigation, represents a new generation of mechanical valves aimed at enhancing durability and hemodynamic outcomes.

What other types of research exist?

Promising novel alternatives to the Foldax Polymer Aortic Valve for aortic valve disease patients in 2024 include: 1) Transcatheter Aortic Valve Replacement (TAVR) with next-generation valves such as the Edwards SAPIEN 3 Ultra and Medtronic Evolut PRO+, which offer minimally invasive options with improved hemodynamic performance and reduced complications. 2) Advanced bioprosthetic valves like the Inspiris Resilia valve, which incorporates advanced tissue technology to enhance durability and reduce calcification. 3) The JenaValve Trilogy Heart Valve System, designed for both aortic stenosis and aortic regurgitation, providing a versatile and effective treatment option.

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Polymer Aortic Valve

Foldax Tria Aortic Valve Replacement for Aortic Valve Disease

N/A

Waitlist Available

Led By Frank Shannon, MD

Research Sponsored by Foldax, Inc

Eligibility Criteria Checklist

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

Must have

Is 18 years or older

Diagnosed with symptomatic aortic valve disease (stenosis and/or regurgitation) where aortic valve replacement is recommended based on pre-operative evaluations

Must not have

Requires a surgical procedure outside of the cardiac area

Requires concomitant left ventricular assist device (LVAD) placement, Impella placement, and/or intra-aortic balloon pump

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years following patient enrollment

Awards & highlights

Summary

This trial is testing a new artificial heart valve made from polymer material in patients who need a replacement for their damaged or malfunctioning aortic valve. The new valve helps regulate blood flow from the heart, aiming to improve heart function and patient safety. The polymeric valve has been developed to last longer and work better than current options.

Who is the study for?

This trial is for adults needing aortic valve replacement due to symptomatic aortic valve disease. Participants must consent to follow-up for 5 years and have no recent strokes, life expectancy under 12 months, multiple valve issues, emergency surgery needs, prior valve surgeries, or other exclusions like severe kidney problems.

What is being tested?

The Foldax Tria Aortic Valve is being tested in this study. It aims to evaluate the safety and performance of this new heart valve device by monitoring improvements in how well blood flows through it after implantation.

What are the potential side effects?

While specific side effects are not listed here, typical risks may include bleeding, infection at the incision site, irregular heart rhythms or potential complications related to heart valve replacements.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have been diagnosed with a heart valve problem and advised to have it replaced.

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I have agreed in writing to participate in the trial after being advised I need an aortic valve replacement.

Exclusion Criteria

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

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I need surgery that is not related to my heart.

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I need a device to help my heart pump blood.

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I need a heart procedure that is not a bypass or root enlargement.

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My kidney function is low or I am on chronic dialysis.

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I need surgery to fix or replace more than one heart valve.

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I have had heart valve surgery before.

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I am planning to have surgery not related to the study within the next year.

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I have had an organ transplant or am waiting for one.

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I have been diagnosed with abnormal calcium levels or hyperparathyroidism.

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I need emergency surgery.

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I haven't needed heart or lung support machines in the last 30 days.

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I have low white blood cell count, anemia, low platelets, or a bleeding/clotting disorder.

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

Primary Effectiveness Endpoint: Hemodynamic Performance Assessment

Primary Effectiveness Endpoint: New York Heart Association Improvement Assessment

Primary Safety Endpoints: Objective Performance Criteria for Flexible Heart Valve Events Assessments

+1 more

Secondary study objectives

Secondary Endpoint: Change in Quality of Life (QOL)

Secondary Endpoint: Hemolysis screen

Secondary Endpoint: ICU Duration of Stay

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tria Aortic ValveExperimental Treatment1 Intervention

Patients receiving the Foldax Tria Aortic Valve

0 / 15Eligibility 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

Mechanical replacement of the aortic valve, such as the Foldax Polymer Aortic Valve, works by substituting the diseased valve with a durable artificial valve. This replacement improves hemodynamic performance by ensuring unidirectional blood flow and reducing the workload on the heart. The mechanical valve's design minimizes regurgitation and stenosis, common issues in aortic valve disease, thereby enhancing cardiac output and reducing symptoms like shortness of breath and fatigue. This is crucial for patients as it significantly improves quality of life and reduces the risk of heart failure and other complications associated with aortic valve disease.