Foldax TRIA Heart Valve for Mitral Valve Disease
(FOLDAX Trial)
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. However, you must be able to handle short-term anticoagulation (blood-thinning medication) as part of the trial.
What data supports the effectiveness of the Foldax TRIA Mitral Valve treatment for Mitral Valve Disease?
What makes the Foldax TRIA Mitral Valve treatment unique for mitral valve disease?
The Foldax TRIA Mitral Valve is unique because it uses a single polymer material called polyhydroxyalkanoates (PHAs) to create a biodegradable and biocompatible heart valve scaffold, which eliminates the need for suturing and offers superior elasticity and mechanical strength compared to previous materials.15678
What is the purpose of this trial?
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.
Research Team
Frank Shannon, MD
Principal Investigator
Beaumont Hospital
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo open heart surgery for the implantation of the Foldax Polymer Mitral Valve
Post-Procedure Recovery
Participants recover from surgery, including ICU and general ward stay
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments for TIA, stroke, and valve migration
Treatment Details
Interventions
- Foldax TRIA Mitral Valve
Find a Clinic Near You
Who Is Running the Clinical Trial?
Foldax, Inc
Lead Sponsor