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Edwards Bioprosthetic Heart Valves for Heart Valve Disease (COMMENCE Trial)
COMMENCE Trial Summary
This trial is to confirm that modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their native or prosthetic aortic or mitral valve.
COMMENCE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOMMENCE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.COMMENCE 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.A heart ultrasound shows something abnormal inside the heart.I am 18 years old or older.My heart's pumping ability is very low, confirmed by a test before valve surgery.I haven't needed help with my breathing or heart function in the last 30 days.I need surgery to replace the root of my aorta.I have had heart inflammation or infection within the last 3 months.I've had a stroke or mini-stroke confirmed by MRI or CT scan in the last 6 months.I am scheduled for aortic or mitral valve replacement, possibly with bypass surgery.I need a valve replacement for my heart based on my doctor's advice.I have had heart valve surgery and still have an implanted device.My non-heart related illness may limit my life to under a year.I have been diagnosed with a thickened heart muscle that obstructs blood flow.I have low white blood cells, anemia, or low platelets with a history of bleeding or clotting issues.I have had an organ transplant or am waiting for one.I am scheduled for aortic valve replacement surgery without needing to stop my circulation.My kidney function is low, with creatinine levels high or I am on chronic dialysis.You need to have a device called a left ventricular assist device (LVAD) put in at the same time.I need emergency surgery.I had a heart attack within the last 30 days before my planned valve surgery.You have had a specific trial device called Model 11000A or Model 11000M implanted before.I need surgery to repair or replace more than one heart valve, except for mitral and tricuspid valves together.I have been diagnosed with abnormal calcium levels and overactive parathyroid glands.You have a record of using drugs or drinking too much alcohol in the last 5 years.
- Group 1: Bioprosthesis: Aortic Model 11000A/ Mitral Model 11000M
- 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
Are there numerous medical facilities conducting this clinical investigation in North America?
"31 medical centres are actively recruiting participants for this clinical trial. Such locations include The Ohio State University Wexner Medical Center in Columbus, The Heart Hospital of Baylor Plano in Plano, and St. Thomas Health in Nashville - along with many other sites across the country."
Are there vacancies available for individuals to join this medical experiment?
"The clinical trial portal indicates that this study is no longer actively looking for patients. It was initially posted on December 1st 2012 and the most recent update occurred at the start of January 2022. Despite not recruiting participants, there are a substantial 1097 other medical experiments searching for volunteers right now."
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