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ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

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

Record History

  1. 2 versions Re-verified since Aug 20, 2024, no change to tracked fieldsv21-v22
  2. Results first posted: Aug 8, 2023 Secondary endpoints: details revised at 1 of 1 entryv20 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 1 entry
  3. Enrollment target: 85 to 86 Study sites: 13 to 14 · Completion date: Dec 2026 to Jun 2032 · Secondary endpoint revisedv19 Show 3 more changesShow less
    • Study sites: 13 to 14
    • Completion date: Dec 2026 to Jun 2032
    • Secondary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date changed from estimate of May 2022 to Jul 14, 2022v18
  5. Primary completion date: Dec 2021 to May 2022v17
Show 15 earlier versionsHide 15 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Sep 2021 to Dec 2021 · Completion date: Oct 2026 to Dec 2026 · Site details revised at 13 of 13 sitesv16 Show 3 more changesShow less
    • Primary completion date: Sep 2021 to Dec 2021
    • Completion date: Oct 2026 to Dec 2026
    • Site details revised at 13 of 13 sites
  2. Trial status: Active, Not Recruiting to Recruiting Site details revised at 13 of 13 sitesv15 Show 1 more changeShow less
    • Site details revised at 13 of 13 sites
  3. Trial status: Recruiting to Active, Not Recruiting Site details revised at 13 of 13 sitesv14 Show 1 more changeShow less
    • Site details revised at 13 of 13 sites
  4. Primary completion date: Apr 2020 to Sep 2021 Primary endpoints: 1 to 2 · Enrollment target: 60 to 85 · Study sites: 12 to 13 · 5 morev13 Show 8 more changesShow less
    • Primary endpoints: 1 to 2
    • Enrollment target: 60 to 85
    • Study sites: 12 to 13
    • Completion date: Oct 2024 to Oct 2026
    • Eligibility criteria expanded, about 171 words
    • Secondary endpoint revised
    • Study title shortened, about 8 words
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 7 to 12v12
  6. Study sites: 6 to 7v11
  7. Study sites: 5 to 6v10
  8. Study sites: 4 to 5v9
  9. Enrollment target: 25 to 60 Primary completion date: Jan 2019 to Apr 2020 · Primary endpoint revised · Completion date: Dec 2022 to Oct 2024 · 3 morev8 Show 6 more changesShow less
    • Primary completion date: Jan 2019 to Apr 2020
    • Primary endpoint revised
    • Completion date: Dec 2022 to Oct 2024
    • Eligibility criteria shortened, about 11 words
    • Secondary endpoint revised
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  10. Enrollment target: 15 to 25 Primary completion date: Dec 2017 to Jan 2019 · Study sites: 1 to 4v7 Show 2 more changesShow less
    • Primary completion date: Dec 2017 to Jan 2019
    • Study sites: 1 to 4
  11. Eligibility criteria expanded, about 1 wordv6 See this version in full on ClinicalTrials.gov ↗
  12. Re-verified, no change to tracked fieldsv5
  13. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Sep 2017 to Aug 22, 2017v4 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2017 to Aug 22, 2017
  14. Start date: Jul 2017 to Sep 2017v3
  15. Re-verified, no change to tracked fieldsv2
  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.
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR). Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Trial Details
NCT Number NCT03130777
Lead Sponsor Edwards Lifesciences
Conditions Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease, Pulmonary Regurgitation
Enrollment 86 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov