Autus Valve Pivotal Study

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05006404
Study type	Interventional
Source	Autus Valve Technologies, Inc.
Contact	Sophie-Charlotte Hofferberth, MD.
Phone	617-390-6468
Email	shofferberth@autusvalve.com
Status	Recruiting
Phase	N/A
Start date	February 5, 2024
Completion date	February 2036

View Details

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