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Autus Valve Pivotal Study

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Final enrollment: 62 participants (planned 51) Primary completion date changed from estimate of Aug 1, 2026 to Aug 24, 2026 · Eligibility criteria expanded, about 30 words · Site details revised at 11 of 12 sites · 1 more Show 4 more changesShow less
    • Primary completion date changed from estimate of Aug 1, 2026 to Aug 24, 2026
    • Eligibility criteria expanded, about 30 words
    • Site details revised at 11 of 12 sites
    • Publications: details revised at 1 of 1 entry
  2. Re-verified, no change to tracked fieldsv15
  3. Changed Sponsor changed: Autus Valve Technologies, Inc. to Edwards Lifesciences
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: 50 to 51 · Site details revised at 12 of 12 sitesv14 Show 2 more changesShow less
    • Enrollment target: 50 to 51
    • Site details revised at 12 of 12 sites
  5. Primary completion date: Aug 2026 to Aug 1, 2026 Completion date: Feb 2036 to Feb 5, 2036 · Site contacts updated at 5 of 12 sitesv13 Show 2 more changesShow less
    • Completion date: Feb 2036 to Feb 5, 2036
    • Site contacts updated at 5 of 12 sites
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 10 to 12v12
  2. Study sites: 9 to 10v11
  3. Study sites: 5 to 9v10
  4. Site contacts updated at 1 of 5 sitesv9
  5. Enrollment target: 15 to 50 Primary completion date: Dec 2024 to Aug 2026 · Start date: Dec 6, 2021 to Feb 5, 2024 · Primary endpoints: 4 to 2 · 5 morev8 Show 8 more changesShow less
    • Primary completion date: Dec 2024 to Aug 2026
    • Start date: Dec 6, 2021 to Feb 5, 2024
    • Primary endpoints: 4 to 2
    • Study sites: 4 to 5
    • Completion date: Dec 2028 to Feb 2036
    • Secondary endpoints shortened, about 190 words
    • Eligibility criteria expanded, about 4 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 3 to 4v7
  7. Secondary endpoints: 25 to 24 Eligibility criteria shortened, about 3 wordsv6 Show 1 more changeShow less
    • Eligibility criteria shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  8. Secondary endpoints revised (25)v5 See this version in full on ClinicalTrials.gov ↗
  9. Primary completion date: Nov 2022 to Dec 2024 Completion date: Nov 2027 to Dec 2028 · Start date: Nov 17, 2021 to Dec 6, 2021 · Site details revised at 3 of 3 sites · 1 morev4 Show 4 more changesShow less
    • Completion date: Nov 2027 to Dec 2028
    • Start date: Nov 17, 2021 to Dec 6, 2021
    • Site details revised at 3 of 3 sites
    • Study title shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  10. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Oct 2022 to Nov 2022 · Completion date: Oct 2027 to Nov 2027 · Start date changed from estimate of Oct 2021 to Nov 17, 2021 · 2 morev3 Show 5 more changesShow less
    • Primary completion date: Oct 2022 to Nov 2022
    • Completion date: Oct 2027 to Nov 2027
    • Start date changed from estimate of Oct 2021 to Nov 17, 2021
    • Eligibility criteria shortened, about 7 words
    • Site details revised at 3 of 3 sites

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites: 0 to 3 Primary completion date: Sep 2022 to Oct 2022 · Completion date: Sep 2027 to Oct 2027 · Start date: Sep 2021 to Oct 2021v2 Show 3 more changesShow less
    • Primary completion date: Sep 2022 to Oct 2022
    • Completion date: Sep 2027 to Oct 2027
    • Start date: Sep 2021 to Oct 2021
  1. 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 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.
Trial Details
NCT Number NCT05006404
Lead Sponsor Edwards Lifesciences
Conditions Congenital Heart Disease
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov