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Foldax TRIA Heart Valve for Mitral Valve Disease (FOLDAX Trial)
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.
FOLDAX Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFOLDAX Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FOLDAX Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: TRIA Mitral Valve
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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