Xeltis Bioabsorbable Pulmonary Valved Conduit Early Feasibility Study

IRB
CHLA-18-00110
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 valve conduit. To assess the rate of conduit failures at 6 months, requiring re-intervention or reoperation.

Study Details
Clinical Trials Government Identifier
NCT03022708
Keywords
RVOT reconstruction, right ventricular outflow tract reconstruction, heart, lung
Eligibility

1.) Patient requiring Right Ventricular Outflow Tract (RVOT) reconstruction, suitable for 16mm or 18mm valve 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)
Does this study also recruit healthy volunteers?
No
Enrollment Status
Open
Coordinator Contact
Brandi Scott
Contact Email
bscott@chla.usc.edu
Coordinator Contact
Sharon Tang
Contact Email
shatang@chla.usc.edu