RecruitingCongenital Heart Disease

Autus Valve Continued Access Study (CAS)

Eligible age

1.5–16 yrs

Accepts

All genders

Locations

10 states

Healthy volunteers

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About this 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.

Sponsor: Edwards Lifesciences

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.