Congenital Heart Disease
Conditions
Brief summary
Prospective, single-arm, multi-center study to evaluate safety and effectiveness 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-implant, 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. In subjects who undergo a post-implant valve expansion, follow-up will continue for a minimum of 1 year after the post-implant valve expansion procedure.
Interventions
Pulmonary valve replacement surgery with the Autus Valve
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Months to 16 Years
Healthy volunteers
No
Inclusion criteria
Candidates must meet all of the following inclusion criteria to be considered for enrollment in this study. 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 body size is suitable for implantation of a study device ranging from 12.7 to 22 mm (internal diameter). 7. Subject and parent/legal representative, where appropriate, are willing to provide informed written consent. 8. 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.
Exclusion criteria
Candidates will be excluded from the study if any of the following conditions are met: 1. Subject requires valve replacement in a non-pulmonary position. 2. Subject has a prosthetic valve at other valve position or will need a prosthetic valve at other valve position (i.e., anticipate additional valve replacements needed within 3 years). 3. Subject has pulmonary arterial hypertension (defined as mean PA pressure ≥25 mmHg). 4. Subject has pulmonary atresia and major aortopulmonary collaterals. 5. Subject has significant peripheral pulmonary artery stenosis. 6. Subject has an active infection requiring current systemic antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics). 7. Subject has active endocarditis or a history of infective endocarditis. 8. Subject has renal insufficiency as determined by a serum creatinine (S-Cr) level ≥2.5 mg/dL within 60 days prior to the Screening Visit, or has end-stage renal disease. 9. Subject has leukopenia (defined as a white blood cell (WBC) count \<3.5 x 103/µL) 10. Subject has acute or chronic anemia (defined as hemoglobin (Hgb) \<10.0 g/dl or 6 mmol/L). 11. Subject has thrombocytopenia (defined as platelet count \<50 x 103/µL. 12. Subject has a known hypersensitivity to anticoagulants and antiplatelet drugs. 13. Subject has a known autoimmune disease or receives immunosuppressant and/or immunostimulant drugs that the Investigator or Eligibility Screening Committee (ESC) believes may negatively affect study outcomes. 14. Subject needs emergency cardiac or vascular surgery or intervention. 15. Positive pregnancy test prior to valve implant procedure in female subjects who have had their first menses. 16. Subject has, in the opinion of the Investigator, a life expectancy of less than 5 years. 17. Subject or parent/legal representative refuses blood transfusions. 18. Subject has medical, social or psychosocial factors that, in the opinion of the Investigator or ESC, could impact safety or compliance with study procedures. 19. Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Valve Implantation Primary Safety Endpoint | 30 Days post-valve implantation | Composite Endpoint: Freedom from a device-related complication through 30 days post-valve implantation as adjudicated by an independent Clinical Events Committee (CEC), including: * Death; * Valve thrombosis requiring intervention; * Symptomatic thromboembolism. |
| Valve Implantation Primary Effectiveness Endpoint | 6 Months post-valve implantation | Acceptable hemodynamic performance at 6 months post-valve implantation, as assessed by the Echocardiography Core Laboratory or Clinical Events Committee, defined as: * A mean RVOT gradient less than or equal to 40 mmHg and * Less than moderate pulmonary regurgitation by transthoracic echo and * No Autus Valve reintervention except for valve expansion to address prosthesis-patient mismatch. |
Countries
United States
Outcome results
None listed