Congenital Heart Disease
Conditions
Brief 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.
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
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
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 a known history of 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 a known history of 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 a known history of leukopenia (defined as a white blood cell \[WBC\] count \<3.5 x 103/µL). 10. Subject has a known history of acute or chronic anemia (defined as hemoglobin \[Hgb\] \<10.0 g/dl or 6 mmol/L). 11. Subject has a known history of thrombocytopenia (defined as platelet count \<50 x 103/µL). 12. Subject has a known history of hypersensitivity to anticoagulants and antiplatelet drugs. 13. Subject has a known history of autoimmune disease or receives immunosuppressant and/or immunostimulant drugs, and 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 |
|---|---|---|
| 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 reintervention; * Symptomatic thromboembolism. |
| Primary Effectiveness Endpoint | 6 Months post-valve implantation | Acceptable hemodynamic performance at 6 months post-valve implantation, defined as a mean RVOT gradient \<=40 mmHg and less than moderate pulmonary regurgitation by transthoracic echo (TTE) as assessed by the Echocardiography Core Laboratory (ECL), and no Autus Valve reintervention except for valve expansion to address prosthesis-patient mismatch, as assessed by the CEC. |
Countries
United States
Contacts
CONTACTJennie Wurgler, MS, ACRP CP
CONTACTPaul Mehoudar, MS
Outcome results
None listed