Autus Valve Pivotal Study
NCT: NCT05006404 · ACTIVE_NOT_RECRUITING
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.
Frequently Asked Questions
What is Autus Valve Pivotal Study?
Autus Valve Pivotal Study is a clinical trial registered under NCT05006404. Current status: ACTIVE_NOT_RECRUITING.
What is the status of NCT05006404?
The current status of NCT05006404 (Autus Valve Pivotal Study) is: ACTIVE_NOT_RECRUITING.
When did Autus Valve Pivotal Study start?
Autus Valve Pivotal Study started on 2024-02-05.
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Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.