Foldax Tria Aortic Valve Replacement for Aortic Valve Disease

Recruiting at 4 trial locations

Overseen By Carlyn Sander, BS, BSN

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Foldax, Inc

No Placebo Group

Trial Summary

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 am 18 years old or older.

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

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

Treatment Details

Interventions

• Foldax Tria Aortic Valve (Polymer 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+