Autus Size-Adjustable Valve for Surgical Pulmonary Valve Replacement Continued Access Study
Autus Valve Technologies, Inc.
Summary
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.
Eligibility
- Age range
- 1–16 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DevicePulmonary Valve Replacement Surgery
Pulmonary valve replacement surgery with the Autus Valve
Locations (10)
- Children's Hospital Los AngelesLos Angeles, California
- Children's Hospital ColoradoAurora, Colorado
- Children's Healthcare of AtlantaAtlanta, Georgia
- Boston Children's HospitalBoston, Massachusetts
- University of Michigan - Mott Children's HospitalAnn Arbor, Michigan
- Columbia University Irving Medical Center/New York Presbyterian Morgan Stanley Children's HospitalNew York, New York