Foldax Tria Aortic Valve Replacement for Aortic Valve Disease

Not currently recruiting at 4 trial locations

Overseen By Carlyn Sander, BS, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Foldax, Inc

Disqualifiers: Renal insufficiency, Stroke, Myocardial infarction, others

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new type of aortic valve, the Foldax Tria, to determine its safety and effectiveness in treating aortic valve disease. Aortic valve disease can lead to stenosis (narrowing) or regurgitation (leakage), causing symptoms such as chest pain or shortness of breath. The trial seeks participants diagnosed with symptomatic aortic valve disease who require a valve replacement based on medical evaluations. Participants should be willing to attend follow-up assessments for up to five years. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future treatments for aortic valve disease.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Foldax Tria Aortic Valve is safe for aortic valve replacement?

Research has shown that the Foldax Tria Aortic Valve is safe for humans. Early results from studies on similar valves, such as the Tria Mitral Valve, indicate that the body accepts these valves well. For instance, no deaths related to the valve or need for repeat surgeries occurred within the first year after the Tria Mitral Valve was implanted. Additionally, studies have demonstrated that the valve functions effectively over time, including improved blood flow.

These findings suggest that the Foldax Tria Aortic Valve could be a dependable choice for patients needing valve replacement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Foldax Tria Aortic Valve is unique because it uses a revolutionary polymer material instead of traditional biological or mechanical components. Unlike conventional options, this polymer is designed to mimic the flexibility and durability of natural heart tissue, potentially reducing wear and tear over time. Researchers are excited about this treatment because it could offer longer-lasting results with fewer complications, such as the need for blood thinners, which are often required with mechanical valves. This innovation may lead to improved quality of life for patients with aortic valve disease.

What evidence suggests that the Foldax Tria Aortic Valve is effective for aortic valve disease?

Research shows that the Foldax Tria Aortic Valve is designed to help people with aortic valve disease. The valve fits securely and seals well, potentially enhancing its performance. Earlier studies on a similar valve, the Tria Mitral Valve, found it safe and effective in improving heart function within the first year. Patients also experienced significant improvements in their daily lives. These early findings suggest that the Foldax Tria Aortic Valve might offer similar benefits for those with aortic valve disease. ^{1 6 7 8 9}

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 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.

Inclusion Criteria

Agrees to attend all follow-up assessments for up to 5 years and is willing to comply with specified follow-up evaluations for the FOLDAX Clinical trial

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

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

Exclusion Criteria

I need surgery that is not related to my heart.

I've had a stroke or mini-stroke confirmed by MRI or CT scan in the last 3 months.

You are expected to live for less than 12 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo open heart surgery to receive the Foldax Tria Aortic Valve

Immediate post-surgery

1 visit (in-person)

Initial Follow-up

Participants are monitored for safety and effectiveness, including ICU stay and hospital recovery

30 days

Multiple visits (in-person)

Extended Follow-up

Participants are monitored for long-term safety and effectiveness, including hemodynamic performance and quality of life assessments

12 months

Regular visits (in-person)

Long-term Follow-up

Participants are monitored for any late-emerging complications such as stroke or transient ischemic attack

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Foldax Tria Aortic Valve

Trial Overview 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.

How Is the Trial Designed?

Group I: Tria Aortic Valve Experimental Treatment 1 Intervention

Patients receiving the Foldax Tria Aortic Valve

Who Is Running the Clinical Trial?

Foldax, Inc

Lead Sponsor

Trials

4

Recruited

180+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03851068

Early Feasibility Study for the Foldax Tria Aortic Heart Valve The study is anticipated to confirm successful clinical safety and clinical effectiveness with significant improvements in clinical hemodynamic performance.

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. tctmd.com tctmd.com/news/polymer-mitral-valve-shows-well-early-long-term-data-key

Polymer Mitral Valve Shows Well Early, but Long-term ... Challenging Case: First Treatment With FOLDAX TRIA™ Surgical Mitral Valve for Rheumatic Heart Disease (RHD)

4. foldax.com foldax.com/clinical-evidence

Clinical Evidence Compelling 1 year results demonstrate a good safety profile, sustained hemodynamic performance, and statistically significant improvement in patient quality-of- ...

5. withpower.com withpower.com/trial/phase-aortic-valve-disease-5-2019-30d2f

Foldax Tria Aortic Valve Replacement for ... This design aims to enhance anchoring and sealing, potentially leading to better outcomes for patients with aortic valve disease. Show more ...

6. 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 ... The TRIA valves have shown excellent and stable hemodynamics in humans and have restored patient quality of life without requiring long-term use of ...

7. sts.org sts.org/news/tech-news-promise-polymer-valve-technology-update-tria-valve-clinical-trials

An Update from the Tria Valve Clinical Trials This demonstrated excellent and sustained outcomes with regard to effective orifice area and hemodynamics, transvalvular gradients, and ...

8. jacc.org jacc.org/doi/10.1016/j.jcin.2021.08.071

Preliminary Evaluation of a Novel Polymeric Valve ... We report the first human experience, early feasibility study (EFS) with the TRIA LP heart valve in patients undergoing surgical aortic valve replacement. This ...

9. dicardiology.com dicardiology.com/content/foldax-announces-one-year-data-tria-mitral-valve

Foldax Announces One-Year Data on Tria Mitral Valve Foldax Announces One-Year Data on Tria Mitral Valve · No valve-related mortality or reinterventions · >50% reduction in mean gradient (9.7 mmHg to ...