NCT07466745

Autus Valve Continued Access Study (CAS)

Autus Size-Adjustable Valve for Surgical Pulmonary Valve Replacement Continued Access Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Autus Valve Technologies, Inc. · Industry
• Sex: All
• Age: 18 Months – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Heart Disease

Interventions

Type	Name	Description
DEVICE	Pulmonary Valve Replacement Surgery	Pulmonary valve replacement surgery with the Autus Valve

Timeline

• Start date: 2026-04-15
• Primary completion: 2027-10-30
• Completion: 2036-04-30
• First posted: 2026-03-12
• Last updated: 2026-03-12

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study