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Pulmonary Valve Replacement for Congenital Heart Disease
Study Summary
This trial will evaluate the safety and effectiveness of the Autus Valve in children aged 2-10 years old who require surgical pulmonary valve replacement. The Autus Valve can be expanded to match the subject's body size before implant, and can also be expanded post-implant via transcatheter balloon dilation to accommodate growth. Follow-up will continue for at least 5 years after implant.
- Congenital Heart Disease
Eligibility Criteria
Inclusion Criteria
You will 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.Awards & Highlights
Trial Design
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- You have an autoimmune disease or take drugs that affect your immune system.You must be between 18 months and 16 years old.You have a prosthetic valve in a different location in your body, or you will need a prosthetic valve in a different location within the next 3 years.The size of the subject's pulmonary artery is suitable for the study device to be implanted.You have kidney problems.You have a natural or fixed issue with the pathway of blood leaving the right side of your heart.You have low levels of white blood cells.You have low platelet count.You need to have a heart valve replaced, but not in the pulmonary position.You have high blood pressure in the arteries of your lungs.You have a condition called pulmonary atresia with major aortopulmonary collaterals.You have a significant narrowing in the arteries in your lungs.You need to have another surgery that is not related to the heart at the same time.You have a current or ongoing problem with low red blood cell count.You are allergic to medications that prevent blood from clotting or reduce platelet activity.Your doctors have suggested that you should have surgery to replace your pulmonary valve.You have certain heart problems as seen on an echocardiogram, like severe pulmonary stenosis or moderate to severe pulmonary regurgitation.Your body size is suitable for the device to be placed, and it should fit a range from 12.7 to 22 mm in diameter.
- Group 1: Autus Valve 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
Could you explain the restrictions around age for this particular clinical trial?
"This trial is seeking young participants who are between 18 months and 11 years old."
Who meets the qualifications for this clinical trial?
"This clinical trial is enrolling 15 people who have heart diseases and are between the ages of 18 months and 11 years old. The following inclusion criteria must be met in order to be considered for enrollment:-Subject's body size is suitable for implantation of a study device ranging from 12.7 to 22 mm (internal diameter)-Age 2 to 10 years old (± 6 months)-Male or female-Subject has a native or repaired right ventricular outflow tract-Subject has been recommended for surgical pulmonary valve replacement by treating clinical team (cardiologist and cardiac surgeon)-Se"
Are people still able to apply for this experiment?
"That is correct. As shown on clinicaltrials.gov, this clinical trial is looking for 15 patients from 3 locations. The trial was first posted on December 6th, 2021 and was last edited on September 13th, 2022."
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