Autus Valve Continued Access Study (CAS)
ConditionCongenital Heart Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-16
SponsorEdwards Lifesciences
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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 a known history of pulmonary atresia and major aortopulmonary collaterals.
Trial design
Treatments tested in this trial
- Pulmonary Valve Replacement Surgery
Treatment groups
36 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov