Autus Valve for Congenital Heart Disease in Children
This study is testing the Autus Valve, a special heart valve that can be adjusted in size, for children with congenital heart disease (a heart problem present at birth) who need a new pulmonary valve. The Autus Valve can be made bigger before surgery to fit your child, and can also be expanded later using a balloon if your child grows. We want to see how safe the Autus Valve is 30 days after surgery and how well it works after 6 months. Children aged 18 months to 16 years who need a pulmonary valve replacement may be able to join. The study is currently unclear on its recruitment status.
- Study design
- This is a single-arm study, meaning all participants receive the Autus Valve. It plans to enroll 36 children.
- What's involved
- Your child will have evaluations before the valve implant, right after surgery, at hospital discharge, and at 30 days, 6 months, and yearly for 10 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 10 years after the valve implantation.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Autus Valve Continued Access Study (CAS)
At a glance
Conditions
NCT07466745
Where you'd take part
This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Boston Children's Hospital
Boston, Massachusettsstudy coordinator listed
Not yet recruiting
Children's Healthcare of Atlanta
Atlanta, Georgiastudy coordinator listed
Not yet recruiting
Children's Hospital Colorado
Aurora, Coloradostudy coordinator listed
Not yet recruiting
Children's Hospital Los Angeles
Los Angeles, Californiastudy coordinator listed
Not yet recruiting
Columbia University Irving Medical Center/New York Presbyterian Morgan Stanley Children's Hospital
New York, New Yorkstudy coordinator listed
Not yet recruiting
Duke University
Durham, North Carolinastudy coordinator listed
Not yet recruiting
Nationwide Children's Hospital
Columbus, Ohiostudy coordinator listed
Not yet recruiting
Seattle Children's Hospital
Seattle, Washingtonstudy coordinator listed
Not yet recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Primary Safety Endpoint30 Days post-valve implantation
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 reintervention; * Symptomatic thromboembolism.
- Primary Effectiveness Endpoint6 Months post-valve implantation
Acceptable hemodynamic performance at 6 months post-valve implantation, defined as a mean RVOT gradient \<=40 mmHg and less than moderate pulmonary regurgitation by transthoracic echo (TTE) as assessed by the Echocardiography Core Laboratory (ECL), and no Autus Valve reintervention except for valve expansion to address prosthesis-patient mismatch, as assessed by the CEC.