Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07466745 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Autus Valve Continued Access Study (CAS)

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Start date changed from estimate of Jul 30, 2026 to Jul 27, 2026 · Site details revised at 10 of 10 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Jul 30, 2026 to Jul 27, 2026
    • Site details revised at 10 of 10 sites
  2. Start date: Apr 15, 2026 to Jul 30, 2026v2
  3. Changed Sponsor changed: Autus Valve Technologies, Inc. to Edwards Lifesciences
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07466745
Lead Sponsor Edwards Lifesciences
Conditions Congenital Heart Disease
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov