CHLA Clinical Research Studies

Having volunteers participate in research studies and clinical trials is critical to our research efforts. Thousands of children and families are involved in our patient-centered studies every year. Many of the treatments used today are based on the results of past research studies and clinical trials conducted with our patients. Our scientific and clinical experts take the best ideas from the laboratory -- to the patient -- in the form of promising new treatments.

By searching our study directory, you may identify research that could impact the life of your child or of another child you know. Because the number of available research studies and clinical trials for children nationwide is small, every participant makes a significant contribution.

In addition to enrolling children with certain diseases in order to study treatments and prevention of those diseases, we also need to study healthy children. Ask your child’s doctor about volunteer study options that may be suitable for your child.

Please contact the study staff listed in your search results for more information.

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Study Details - ID: CHLA-18-00110
Health/Science/Disease Category:
Congenital heart malformations
Short Name:
Xeltis Bioabsorbable Pulmonary Valved Conduit Early Feasibility Study
Full Title of Study:
Prospective, non-randomized, open label clinical study to assess the feasibility of the Bioabsorbable pulmonary valved conduit in subjects undergoing Right Ventricular Outflow Tract (RVOT) reconstruction
Phase/Type of Study:
Phase I
Purpose of Research:
To assess the survival rate of subjects at 6 and 12 months following implantation of the Bioabsorbable pulmonary valved conduit. To assess the rate of conduit failures at 6 months, requiring re-intervention or reoperation.
Eligibility:
1. Patient requiring Right Ventricular Outflow Tract (RVOT) reconstruction, suitable for 16mm or 18mm valved conduit. 2. Male or Female 3. Age > 2 years and < 22 years 4. Right Ventricular to Pulmonary Artery peak gradient > 35mm Hg or moderate or severe Pulmonary regurgitation (≥ 3+), or have both (except for the patients undergoing a Ross procedure).
Time Commitment/Requirements:
This is a 5 year study and clinical data will be collected at the time of pre-implant baseline, implant, and planned follow-ups at Day 1, Day 7/Discharge (whatever comes first), 6 weeks, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, 48 months and 60 months post implant.
Primary Investigator:
Cynthia Herrington, MD
Coordinator Contact Name:
Sharon Tang
Phone Number:
323-361-7299
Email:
shatang@chla.usc.edu
Clinical Trials .Gov Identifier:
NCT03022708