AUTUS size-adjustable valve
Study overview
The AUTUS size-adjustable valve is under investigation in a 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.
For questions about joining this study, and information on where the study is taking place, contact:
- Name: Jennie Wurgler, MS, ACRP CP
- Phone Number: 949-250-2500
- Email: Jennie_Wurgler@edwards.com
Additional study details can be found at clinicaltrials.gov
PP--US-13323 v1.0