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New Valve Surgery for Heart Valve Defects (MVEFS Trial)
MVEFS Trial Summary
This trial is to test the safety and effectiveness of a new valve for people who need surgery to repair or replace their right ventricular outflow tract. The trial will help determine if the new valve is safe and effective enough to be used in future patients.
MVEFS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMVEFS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MVEFS Trial Design
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Who is running the clinical trial?
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- You have a pacemaker or mechanical heart valve implanted in the past.Your white blood cell count is too low, based on a test from your local lab.You have a prosthetic heart valve in place.I need surgery for a condition that is not related to my heart.You have a long-term condition where your body's immune system attacks its own cells.I need emergency heart or blood vessel surgery.I do not have an active infection or need for antibiotics currently.My platelet count is below 150,000/mm3, but I can receive a transfusion to qualify.I have anemia but can receive a transfusion to qualify.I am younger than 22 years old.I have a severe chest wall deformity that prevents certain medical procedures.You are allergic to blood thinners, drugs that prevent clotting, or materials used in medical devices.I have an ongoing heart infection.You have a history of alcohol or drug abuse, including using illegal cannabis in the past year.I have an autoimmune disease or am taking drugs that affect my immune system.I do not have a major illness with a life expectancy of less than one year.I have severe heart valve issues needing a replacement.
- Group 1: Experimental Arm
- 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
Is recruitment still occurring for this research study?
"No, according to clinicaltrials.gov this medical trial is not presently accepting participants - it was last updated on the 6th of July 2022. However, 16 other trials are actively recruiting new patients at this moment in time."
Is there an opportunity to participate in this experiment?
"This research is searching for 10 people with truncus arteriosus aged 0-22 that meet specific criteria. These include geographical stability, an informed consent from the legal guardian at their enrolment centre, age under 22 years old, a right ventricular to pulmonary artery mean gradient over 35mm Hg, moderate or severe pulmonary regurgitation (≥3+), and agreement between patient/guardian and physician to return for all necessary follow up visits in compliance with the clinical investigation plan's requirements."
Are participants below the age of 35 admissible for this trial?
"To be eligible for this medical study, applicants must fall between the ages of 0 and 22. 14 trials are accessible to minors while 11 have been designed specifically with elderly patients in mind."
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