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Polymer Mitral Valve
Foldax TRIA Heart Valve for Mitral Valve Disease (FOLDAX Trial)
N/A
Waitlist Available
Research Sponsored by Foldax, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is a candidate for mitral valve replacement due to moderate to severe mitral valve stenosis, moderate to severe mitral valve regurgitation, or moderate to severe mixed mitral stenosis/regurgitation
Is a candidate for mitral valve replacement with cardiopulmonary bypass
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years following patient enrollment
Awards & highlights
FOLDAX Trial Summary
This trial is testing a new kind of heart valve made from a polymer that may be safer and have better clinical outcomes than existing valves.
Who is the study for?
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.Check my eligibility
What is being tested?
The Foldax TRIA Mitral Valve is being tested in this study. The goal is to gather initial data on its safety and how well it works as a replacement for damaged mitral valves. Participants will receive the new valve through surgery using cardiopulmonary bypass.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks of heart valve replacement include bleeding, infection risk at the surgical site, potential reactions to anesthesia or anticoagulants used during/after surgery, and possible complications related to heart function.
FOLDAX Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need a mitral valve replacement due to severe issues with my valve.
Select...
I am eligible for heart valve surgery with a heart-lung machine.
Select...
I can safely receive blood-thinning medication.
Select...
I am 18 years old or older.
FOLDAX Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Effectiveness: Change in New York Heart Association Assessment
Primary Effectiveness Endpoints- Change in Hemodynamic Performance
Primary Safety Endpoints
Secondary outcome measures
ICU Duration of Stay
Kansas City Cardiomyopathy Questionnaire (KCCQ)
New Onset Atrial Fibrillation
+7 moreFOLDAX Trial Design
1Treatment groups
Experimental Treatment
Group I: TRIA Mitral ValveExperimental Treatment1 Intervention
Patients receiving the Foldax Mitral Valve
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Who is running the clinical trial?
Foldax, IncLead Sponsor
3 Previous Clinical Trials
160 Total Patients Enrolled
1 Trials studying Mitral Valve Stenosis
70 Patients Enrolled for Mitral Valve Stenosis
Frank Shannon, MDStudy ChairBeaumont Hospital
1 Previous Clinical Trials
40 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have kidney or liver failure.My blood counts are within normal ranges.I have experienced a sudden change in my ability to move or feel in the last 3 months.I need a mitral valve replacement due to severe issues with my valve.I need emergency surgery.I will need another surgery within a year after my valve replacement.I am eligible for heart valve surgery with a heart-lung machine.I can safely receive blood-thinning medication.My body was found unsuitable for the device during surgery.I do not have an ongoing heart infection or inflammation.My non-heart related illness may shorten my life to under a year.I have not had a heart attack or severe heart problem in the last 30 days.You have tested positive for the COVID-19 virus before the study begins or before a surgery.I have had surgery on my mitral valve, but not a procedure like MitraClip.You are currently in jail or have a mental illness.I am 18 years old or older.I have a condition, like an aortic aneurysm, that increases my surgery risk.
Research Study Groups:
This trial has the following groups:- Group 1: TRIA Mitral Valve
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What objectives is this research endeavor trying to accomplish?
"This medical trial, which aims to measure changes in Hemodynamic Performance over a one-year period post patient recruitment, also assesses the incidence of stroke and transient ischemic attack as well as any readmissions occuring within 30 days of discharge."
Answered by AI
Are there any open enrolments for this clinical investigation?
"According to the information on clinicaltrials.gov, this research is not presently recruiting participants; it was initially posted in February 2021 and last modified a few months ago. However, there are 23 other trials actively searching for patients currently."
Answered by AI
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