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Foldax Tria Aortic Valve Replacement for Aortic Valve Disease
Study Summary
This trial is testing a new aortic valve to see if it is safe and effective. The goal is to show that it is better than the current standard valve.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.You are expected to live for less than 12 months.I need a device to help my heart pump blood.I am 18 years old or older.I need a heart procedure that is not a bypass or root enlargement.My kidney function is low or I am on chronic dialysis.I have been diagnosed with HOCM, not just muscle thickening found during surgery.I have been diagnosed with a heart valve problem and advised to have it replaced.I need surgery to fix or replace more than one heart valve.I have agreed in writing to participate in the trial after being advised I need an aortic valve replacement.I have had heart valve surgery before.I am planning to have surgery not related to the study within the next year.I have had an organ transplant or am waiting for one.You currently have COVID-19.Your heart's pumping function is very low, as shown in an ultrasound test.I have been diagnosed with abnormal calcium levels or hyperparathyroidism.I have not had heart inflammation in the last 3 months.I need emergency surgery.You have a blood clot or growth inside your heart as shown by an ultrasound test.I had a heart attack within the last 30 days before my planned valve surgery.I haven't needed heart or lung support machines in the last 30 days.I have low white blood cell count, anemia, low platelets, or a bleeding/clotting disorder.You have a record of using drugs or drinking heavily in the last 5 years.
- Group 1: Tria Aortic 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
Has the enrollment process for this clinical trial already begun?
"According to clinicaltrials.gov, this particular study is not currently open for recruitment. Initially posted on June 18th 2019 and last updated February 24th 2022, it is now closed - however, 180 other active trials are seeking participants at the moment."
What outcomes is this clinical trial attempting to achieve?
"According to the study's sponsor, Foldax Inc., they will be measuring primary outcome of hemodynamic performance over 12 months. They are also evaluating secondary outcomes such as new onset atrial fibrillation (confirmed on ECG), length of stay in ICU post-implantation, and patient readmission rate after initial discharge."
How many medical facilities are actively conducting this research?
"The 5 locales hosting this medical trial consist of OhioHealth Riverside in Columbus, The Christ Hospital located at Cincinnati and Ascension Via Christi St. Francis Hospital in Wichita among others."
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