Autus Valve Pivotal Study (NCT05006404)
Autus Size-Adjustable Valve for Surgical Pulmonary Valve Replacement Pivotal Study
🩺 Plain-English Summary (8th-Grade Level)
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: Review the eligibility criteria below.
Location: Children's Hospital Los Angeles — Los Angeles, California
Age range: 18 Months to 16 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (12 Sites)
- Children's Hospital Los Angeles — Los Angeles, California
- Children's Hospital Colorado — Aurora, Colorado
- Children's Healthcare of Atlanta — Atlanta, Georgia
- Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois
- Boston Children's Hospital — Boston, Massachusetts
- University of Michigan - Mott Children's Hospital — Ann Arbor, Michigan
- Columbia University Irving Medical Center/New York Presbyterian Morgan Stanley Children's Hospital — New York, New York
- Duke University — Durham, North Carolina
- Nationwide Children's Hospital — Columbus, Ohio
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- University of Utah - Intermountain Primary Children's Hospital — Salt Lake City, Utah
- Seattle Children's Hospital — Seattle, Washington
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Congenital Heart Disease
- Technical Development for Pediatric Cardiovascular MRI — Washington D.C., District of Columbia
- Harmony TPV Post-Approval Study — Birmingham, Alabama
- The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study — Los Angeles, California
- Peer Coaching Intervention in Young Adults With Congenital Heart Disease — Durham, North Carolina
- SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure — Toronto, Ontario
Explore by condition: All Congenital Heart Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.