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Clinical Trial

Autus Valve Continued Access Study (CAS)

NCT: NCT07466745 · RECRUITING

NCT IDNCT07466745
StatusRECRUITING
Start Date2026-07-27
Completion2036-04-30
SponsorEdwards Lifesciences (INDUSTRY)
First posted
Last updated

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.

Frequently Asked Questions

What is Autus Valve Continued Access Study (CAS)?

Autus Valve Continued Access Study (CAS) is a clinical trial registered under NCT07466745. Current status: RECRUITING.

What is the status of NCT07466745?

The current status of NCT07466745 (Autus Valve Continued Access Study (CAS)) is: RECRUITING.

When did Autus Valve Continued Access Study (CAS) start?

Autus Valve Continued Access Study (CAS) started on 2026-07-27.

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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.