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PARTNER 3 Trial - Mitral Valve in Valve

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

Record History

  1. 2 versions Re-verified since Sep 30, 2024, no change to tracked fieldsv15-v16
  2. Results first posted: Oct 24, 2023 Secondary endpoints revised (4)v14 Show 1 more changeShow less
    • Secondary endpoints revised (4)

    See this version in full on ClinicalTrials.gov ↗

  3. Enrollment target: 50 to 53 Study sites: 19 to 12 · Secondary endpoints revised (4) · Primary endpoint revisedv13 Show 3 more changesShow less
    • Study sites: 19 to 12
    • Secondary endpoints revised (4)
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 17 to 19 Primary completion date changed from estimate of Sep 2022 to Aug 16, 2022 · Completion date: Sep 2031 to Aug 2031v12 Show 2 more changesShow less
    • Primary completion date changed from estimate of Sep 2022 to Aug 16, 2022
    • Completion date: Sep 2031 to Aug 2031
  5. Trial status: Recruiting to Active, Not Recruiting Study sites: 19 to 17 · Primary completion date: Aug 1, 2022 to Sep 2022 · Completion date: Aug 1, 2026 to Sep 2031v11 Show 3 more changesShow less
    • Study sites: 19 to 17
    • Primary completion date: Aug 1, 2022 to Sep 2022
    • Completion date: Aug 1, 2026 to Sep 2031
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 17 to 19 Secondary endpoints: details revised at 3 of 4 entriesv10 Show 1 more changeShow less
    • Secondary endpoints: details revised at 3 of 4 entries
  2. Primary completion date: Aug 1, 2020 to Aug 1, 2022 Primary endpoint revised · Completion date: Aug 1, 2024 to Aug 1, 2026 · Eligibility criteria expanded, about 422 words · 2 morev9 Show 5 more changesShow less
    • Primary endpoint revised
    • Completion date: Aug 1, 2024 to Aug 1, 2026
    • Eligibility criteria expanded, about 422 words
    • Secondary endpoints: 1 to 4
    • Site contacts updated at 1 of 17 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 14 to 17v8
  4. Re-verified, no change to tracked fieldsv7
  5. Study sites: 11 to 14v6
  6. Study sites: 2 to 11v5
  7. Study sites: 1 to 2v4
  8. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 2017 to Feb 1, 2018 · Study sites: 0 to 1 · Eligibility criteria shortened, about 2 wordsv3 Show 3 more changesShow less
    • Start date changed from estimate of Oct 2017 to Feb 1, 2018
    • Study sites: 0 to 1
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  9. Start date: Aug 2017 to Oct 2017v2
  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 assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
Trial Details
NCT Number NCT03193801
Lead Sponsor Edwards Lifesciences
Conditions Mitral Valve Insufficiency, Mitral Valve Disease, Mitral Valve Regurgitation, Heart Failure
Enrollment 53 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov