Autus Valve Continued Access Study (CAS)
Public ClinicalTrials.gov record NCT07466745. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Autus Size-Adjustable Valve for Surgical Pulmonary Valve Replacement Continued Access Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07466745
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 36 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Months to 16 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 26, 2026
- Primary completion
- Oct 29, 2027
- Completion
- Apr 29, 2036
- Last update posted
- Aug 9, 2026
2026 – 2036
United States locations
- U.S. sites
- 10
- U.S. states
- 10
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | Not yet recruiting |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | Not yet recruiting |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | Not yet recruiting |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | Not yet recruiting |
| University of Michigan - Mott Children's Hospital | Ann Arbor | Michigan | 48109 | Recruiting |
| Columbia University Irving Medical Center/New York Presbyterian Morgan Stanley Children's Hospital | New York | New York | 10032 | Not yet recruiting |
| Duke University | Durham | North Carolina | 27703 | Not yet recruiting |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | Not yet recruiting |
| University of Utah - Intermountain Primary Children's Hospital | Salt Lake City | Utah | 84113 | Not yet recruiting |
| Seattle Children's Hospital | Seattle | Washington | 98105 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07466745, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 9, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07466745 live on ClinicalTrials.gov.