Edwards Lifesciences
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.
Inclusion Criteria: 1. Age 18 months to 16 years. 2. Male or female. 3. Subject has a native or repaired right ventricular outflow tract. 4. Subject has been recommended for surgical pulmonary valve replacement by treating clinical team (cardiologist and cardiac surgeon). 5. Subject has at least one of the following echocardiographic findings: 1. Severe pulmonary stenosis (defined as RV to PA peak instantaneous gradient ≥60 mmHg); 2. Moderate or greater pulmonary regurgitation; 3. Moderate or greater pulmonary stenosis plus moderate or greater pulmonary regurgitation. 6. Subject's b…
Pulmonary valve replacement surgery with the Autus Valve