Xeltis Bioabsorbable Pulmonary Valved Conduit Early Feasibility 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
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.
CHLA IRB Number
CHLA-18-00110
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).
Clinical Trials Government Identifier
NCT03022708
Enrollment Status
Open
Does this study also recruit healthy volunteers?
No
Coordinator Contact
Brandi Scott
Contact Email
bscott@chla.usc.edu
Coordinator Contact
Sharon Tang
Contact Email
shatang@chla.usc.edu