NCT05006404

Autus Valve Pivotal Study

Autus Size-Adjustable Valve for Surgical Pulmonary Valve Replacement Pivotal Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Autus Valve Technologies, Inc. · Industry
• Sex: All
• Age: 18 Months – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Heart Disease

Interventions

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

Timeline

• Start date: 2024-02-05
• Primary completion: 2026-08-01
• Completion: 2036-02-05
• First posted: 2021-08-16
• Last updated: 2026-03-09

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study