Foldax Tria Aortic Valve Replacement for Aortic Valve Disease

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

40 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. It's best to discuss this with the trial coordinators or your doctor.

How does the Foldax Tria Aortic Valve treatment differ from other treatments for aortic valve disease?

The Foldax Tria Aortic Valve is unique because it uses a biostable polymer and a self-expanding nitinol wire frame, which may offer improved durability and reduced leakage compared to traditional valves. This design aims to enhance anchoring and sealing, potentially leading to better outcomes for patients with aortic valve disease. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Frank Shannon, MD

Principal Investigator

Beaumont Hospital

Eligibility Criteria

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.

Currently incarcerated or unable to give voluntary informed consent

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

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

In Vitro Hydrodynamic Assessment of a New Transcatheter Heart Valve Concept (the TRISKELE). [2021]

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

Sutureless Aortic Valve Replacement in the Setting of Triple-Valve Surgery. [2015]

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

Techniques of aortic valve repair. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Assessment of long-term outcomes: aortic valve reimplantation versus aortic valve and root replacement with biological valved conduit in aortic root aneurysm with tricuspid valve. [2021]

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

Stent and leaflet stresses in 26-mm, third-generation, balloon-expandable transcatheter aortic valve. [2021]