Study Overview
This is a prospective, single-arm, multi-center pivotal study designed to evaluate the safety and effectiveness of the Autus Size-Adjustable Valve. This innovative medical device is intended for pediatric patients requiring surgical pulmonary valve replacement. The key feature of the Autus Valve is its ability to be expanded via a minimally-invasive catheter procedure to accommodate a child's growth, potentially reducing the need for repeated open-heart surgeries.
Progress & Timeline
The study is actively recruiting participants across multiple centers in the United States. This section provides a visual summary of the enrollment progress against the study's goal and highlights the key milestones in its long-term timeline.
Enrollment Status
*Actual enrollment is an analyst estimate. See Sources & Methodology section for details.
Status
Recruiting
Study Start Date
February 5, 2024
Primary Completion
August 2026 (Est.)
Study Completion
February 2036 (Est.)
Participant Eligibility
To be considered for this study, potential participants must meet specific criteria. Below is a summary of the key requirements. Please consult with the study coordinators at the listed locations for a complete evaluation.
Age Range
2 to 21 Years
Sex
All
- Recommended for surgical pulmonary valve replacement.
- Has a native or repaired right ventricular outflow tract.
- Body size suitable for implantation of a study device.
- One of the following findings: Severe pulmonary stenosis, Moderate or greater pulmonary regurgitation, or a combination of both.
- Willingness to provide informed written consent.
- Requires valve replacement in a non-pulmonary position.
- Has a prosthetic valve at another valve position.
- Has pulmonary arterial hypertension.
- Has an active infection requiring systemic antibiotic therapy.
- Has active endocarditis.
- Known hypersensitivity to anticoagulants and antiplatelet drugs.
- Participating in another investigational study of a new drug or device.
Recruiting Locations
This study is being conducted at several leading pediatric hospitals across the country. Click on a location below to view more details, including contact information and principal investigators. If you believe you or your child may be eligible, please reach out to the research coordinator at the nearest facility.
This log provides traceability for key claims presented in the dashboard, following a dual-citation standard to ensure data integrity.
| Claim | Primary Source | Secondary Source / Notes | Date | Fresh? |
|---|---|---|---|---|
| Enrollment goal is 50 participants. | AutusValve.com | Provided NCT05006404.json (lists 65). Primary source prioritized due to being more recent. | Jan 2025 | Fresh |
| Actual enrollment is ~10 participants (Estimate). | NY-Presbyterian Article | Estimate derived from confirmed 4 enrollments at one of six sites. | Jun 2024 | Fresh |
| Age range is 18 months to 16 years. | Provided NCT05006404.json | Boston Children's Page | Jan 2025 | Fresh |