Autus Size-Adjustable Valve for Surgical Pulmonary Valve Replacement Continued Access Study
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.
• Age 18 months to 16 years.
• Male or female.
• Subject has a native or repaired right ventricular outflow tract.
• Subject has been recommended for surgical pulmonary valve replacement by treating clinical team (cardiologist and cardiac surgeon).
• Subject has at least one of the following echocardiographic findings:
‣ Severe pulmonary stenosis (defined as RV to PA peak instantaneous gradient ≥60 mmHg);
⁃ Moderate or greater pulmonary regurgitation;
⁃ Moderate or greater pulmonary stenosis plus moderate or greater pulmonary regurgitation.
• Subject's body size is suitable for implantation of a study device ranging from 12.7 to 22 mm (internal diameter).
• Subject and parent/legal representative, where appropriate, are willing to provide informed written consent.
• Subject and parent/legal representative, where appropriate, and treating physician agree that the subject will return for, and comply with, all required study assessments and follow-up visits.