Autus Valve Continued Access Study (CAS)

Prospective, single-arm, multi-center, continued access study of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement. The Autus Valve may be expanded pre-implant to match the subject's body size. Subjects will be evaluated prior to the Autus Valve implant procedure, immediately post-implantation, at hospital discharge, 30 days, 6 months, and annually through 10 years. The Autus Valve may be expanded post-implant via transcatheter balloon dilation to accommodate growth of the subject.

NCT Number	NCT07466745
Lead Sponsor	Edwards Lifesciences
Conditions	Congenital Heart Disease
Enrollment	36 participants
Start Date	2026-07-27
Primary Completion	2027-10-30 (estimated)
Study Completion	2036-04-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-10