Autus Valve Pivotal Study
Public ClinicalTrials.gov record NCT05006404. 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 Pivotal Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05006404
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 62 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
- Feb 5, 2024 (Actual)
- Primary completion
- Aug 24, 2026 (Actual)
- Completion
- Feb 5, 2036 (Estimated)
- Last update posted
- Sep 28, 2026
2024 – 2036
United States locations
- U.S. sites
- 12
- U.S. states
- 12
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | — |
| Ann and Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan - Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| Columbia University Irving Medical Center/New York Presbyterian Morgan Stanley Children's Hospital | New York | New York | 10032 | — |
| Duke University | Durham | North Carolina | 27703 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| University of Utah - Intermountain Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
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 NCT05006404, 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 Sep 28, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05006404 live on ClinicalTrials.gov.