Autus Valve Pivotal Study
AI Description
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.
- Who can join
- child
- Participants
- 51
- Expected completion
- 2036-02-05
- Funded by
- industry
Conditions studied
Congenital Heart Disease
What is being tested
- DEVICE: Pulmonary Valve Replacement Surgery
What it measures
- Valve Implantation Primary Effectiveness Endpoint, Acceptable hemodynamic performance at 6 months post-valve implantation, as assessed by the Echocardiography Core Laboratory or Clinical Events Committee, defined as: * A mean RVOT gradient less than or equal to 40 mmHg and * Less than moderate pulmonary regurgitation by transthoracic echo and * No Autus Valve reintervention except for valve expansion to address prosthesis-patient mismatch., 6 Months post-valve implantation
- Valve Implantation Primary Safety Endpoint, Composite Endpoint: Freedom from a device-related complication through 30 days post-valve implantation as adjudicated by an independent Clinical Events Committee (CEC), including: * Death; * Valve thrombosis requiring intervention; * Symptomatic thromboembolism., 30 Days post-valve implantation
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Ann & Robert H. Lurie Children’s Hospital of Chicago
Chicago, IL
Boston Children's Hospital
Boston, MA
Children's Hospital Los Angeles
Los Angeles, CA
Children's Hospital of Philadelphia
Philadelphia, PA
Duke University Hospital
Durham, NC
Nationwide Children's Hospital
Columbus, OH
Seattle Children’s
Seattle, WA
University of Colorado Hospital
Aurora, CO
University of Michigan Health System
Ann Arbor, MI
University of Utah Health
Salt Lake City, UT
Registry entry updated 2026-07-17
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.