The purpose of this research study is to find out if stem cells from umbilical cord blood (collected at birth) can strengthen the muscle of the right side of the heart for patients diagnoses with Hypoplastic Left Heart Syndrome who are scheduled to undergo the Glenn Surgical procedure. IRB 17-013819
Cardiac Center Clinical Studies
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The Harmony Valve study is for patients in need of pulmonary valve replacement. The HarmonyTM Valve is a transcatheter pulmonary valve specifically designed for patients in need of a pulmonary valve replacement who do not want to have to undergo surgery. Surgical placement of a new valve is the most common treatment for a nonworking pulmonary valve, however, there are many risks associated with open heart surgery and it is followed by months of recovery. A less invasive approach for treatment is now available by placement of a pulmonary valve by a transcatheter procedure. The Harmony Valve has not been approved by the FDA yet for commercial use and is only available by participating in the study.
Please contact Dr. Matthew Gillespie (email@example.com) if you or your patient may be interested in participating in the trial of this device.
The purpose of this research study is to learn more about improving the treatment and outcomes for patients who have a diagnosis of a single ventricle, such as Hypoplastic Left Heart Syndrome (HLHS) or similar heart defects. You will be asked to fill out a questionnaire called the Ages and Stages Questionnaire about your child. It is used widely in pediatrics to check on babies’ development. We will ask you to fill this out about every three months during your child’s 15 months of life. Also, information will be collected about your child’s surgeries, clinic visits and hospital stays from diagnosis through the first year of life. The information may be used to help us understand an infant's response to surgery and medical treatment and may be used to improve care for children with single ventricles.