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NCT07466745 · ClinicalTrials.gov registry record · NA
Autus Valve Continued Access Study (CAS)
A NA study, sponsored by Edwards Lifesciences.
- Not yet
- Registry status
- NA
- Development phase
- 36
- Enrollment target
NCT07466745 is a NA study that has not yet begun recruiting, run by Edwards Lifesciences. The registered enrollment target is 36 participants.
The verdict
NCT07466745, a NA study, has not yet begun recruiting, sponsored by Edwards Lifesciences.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
Study Summary
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.
Interventions
- DEVICE Pulmonary Valve Replacement Surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2026-04-15 |
| Est. Completion | 2036-04-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07466745
The ClinicalTrials.gov registry entry for NCT07466745 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edwards Lifesciences, which has 57 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pulmonary Valve Replacement Surgery is the first listed.
NCT07466745 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07466745 about?
NCT07466745 is a clinical study titled "Autus Valve Continued Access Study (CAS)". 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 p...
What is the current status of trial NCT07466745?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 36 participants. The study started on 2026-04-15. Estimated completion is 2036-04-30.
What interventions are being tested in trial NCT07466745?
The interventions under investigation include: Pulmonary Valve Replacement Surgery (DEVICE).
Who is sponsoring clinical trial NCT07466745?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
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