Autus Valve Pivotal Study (NCT05006404) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Autus Valve Pivotal Study
United States51 participantsStarted 2024-02-05
Plain-language 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.
Who can participate
Age range18 Months – 16 Years
SexALL
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Inclusion criteria
✓. Age 18 months to 16 years.
✓. Male or female.
✓. Subject has a native or repaired right ventricular outflow tract.
✓. Subject has been recommended for surgical pulmonary valve replacement by treating clinical team (cardiologist and cardiac surgeon).
✓. Subject has at least one of the following echocardiographic findings:
✓. Severe pulmonary stenosis (defined as RV to PA peak instantaneous gradient ≥60 mmHg);
✓. Moderate or greater pulmonary regurgitation;
✓. Moderate or greater pulmonary stenosis plus moderate or greater pulmonary regurgitation.
Exclusion criteria
✕. Subject requires valve replacement in a non-pulmonary position.
✕. 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).
✕. Subject has pulmonary arterial hypertension (defined as mean PA pressure ≥25 mmHg).
✕. Subject has pulmonary atresia and major aortopulmonary collaterals.
✕. Subject has significant peripheral pulmonary artery stenosis.
✕. Subject has an active infection requiring current systemic antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics).
✕. Subject has active endocarditis or a history of infective endocarditis.
✕. 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.