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NCT05006404 · ClinicalTrials.gov registry record · NA
Autus Valve Pivotal Study
A NA study of Congenital Heart Disease, sponsored by Autus Valve Technologies.
- Active
- Registry status
- NA
- Development phase
- 51
- Enrollment target
- 12
- Study locations
NCT05006404: Active NA study of Congenital Heart Disease, sponsored by Autus Valve Technologies.
NCT05006404 is a NA study of Congenital Heart Disease that is active but no longer recruiting, run by Autus Valve Technologies. The registered enrollment target is 51 participants, below the 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (89% lower). The trial reports 12 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05006404, a NA study of Congenital Heart Disease, is active but no longer recruiting, sponsored by Autus Valve Technologies.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 51 participants
- Enrollment target
- 12
- Study locations
Study Summary
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.
Primary Outcome
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 intervention; * Symptomatic thromboembolism.
Conditions Studied
Interventions
- DEVICE Pulmonary Valve Replacement Surgery
Study Locations (12)
California
- Children's Hospital Los Angeles - Los Angeles
Colorado
- Children's Hospital Colorado - Aurora
Georgia
- Children's Healthcare of Atlanta - Atlanta
Illinois
- Ann and Robert H. Lurie Children's Hospital of Chicago - Chicago
Massachusetts
- Boston Children's Hospital - Boston
Michigan
- University of Michigan - Mott Children's Hospital - Ann Arbor
New York
- Columbia University Irving Medical Center/New York Presbyterian Morgan Stanley Children's Hospital - New York
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2024-02-05 |
| Est. Completion | 2036-02-05 |
| Phase | NA |
What the registry record for NCT05006404 still lists
NCT05006404 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Congenital Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which Pulmonary Valve Replacement Surgery is the first listed.
NCT05006404 lists 12 locations in 12 states (California, Colorado, Georgia).
Frequently Asked Questions
What is clinical trial NCT05006404 about?
NCT05006404 is a clinical study titled "Autus Valve Pivotal Study". 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 ...
What is the current status of trial NCT05006404?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 51 participants. The study started on 2024-02-05. Estimated completion is 2036-02-05.
What conditions does trial NCT05006404 study?
This clinical trial studies the following conditions: Congenital Heart Disease.
What interventions are being tested in trial NCT05006404?
The interventions under investigation include: Pulmonary Valve Replacement Surgery (DEVICE).
Who is sponsoring clinical trial NCT05006404?
This trial is sponsored by Autus Valve Technologies, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05006404 being conducted?
This trial has 12 study locations across California, Colorado, Georgia, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05006404's enrollment target sits among peer trials
51 39th of 63 higher than 24 of 63 other Congenital Heart Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Congenital Heart Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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