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PARTNER 3 Trial - Aortic Valve-in-Valve

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv18
  2. Study sites: 52 to 51v17
  3. Primary completion date: Dec 2021 to Jan 2033 Completion date: Mar 2027 to Apr 2038 · Interventions: Edwards SAPIEN 3 THV (Device) to Edwards SAPIEN 3/SAPIEN 3 Ultra THV (Device) · Study description expanded, about 7 words · 1 morev16 Show 4 more changesShow less
    • Completion date: Mar 2027 to Apr 2038
    • Interventions: Edwards SAPIEN 3 THV (Device) to Edwards SAPIEN 3/SAPIEN 3 Ultra THV (Device)
    • Study description expanded, about 7 words
    • Study arms: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv15
  5. Primary endpoint revised Completion date: Mar 5, 2027 to Mar 2027 · Interventions: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX (Device) to Edwards SAPIEN 3 THV (Device) · Eligibility criteria expanded, about 266 words · 4 morev14 Show 7 more changesShow less
    • Completion date: Mar 5, 2027 to Mar 2027
    • Interventions: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX (Device) to Edwards SAPIEN 3 THV (Device)
    • Eligibility criteria expanded, about 266 words
    • Secondary endpoints: 2 to 5
    • Study description shortened, about 27 words
    • Study sites revised (52)
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

Show 12 earlier versionsHide 12 earlier versions
  1. Re-verified, no change to tracked fieldsv13
  2. Site details revised at 1 of 52 sitesv12
  3. Primary completion date: Oct 5, 2018 to Dec 2021 Study sites: 55 to 52v11 Show 1 more changeShow less
    • Study sites: 55 to 52
  4. Phase: Phase 3 to Not applicable Study sites: 53 to 55v10 Show 1 more changeShow less
    • Study sites: 53 to 55
  5. Site contacts updated at 53 of 53 sitesv9
  6. Site details revised at 10 of 53 sitesv8
  7. Secondary endpoints: details revised at 1 of 2 entriesv7
  8. Site details revised at 4 of 53 sitesv6
  9. Site details revised at 6 of 53 sitesv5
  10. Site details revised at 5 of 53 sitesv4
  11. Study sites: 51 to 53v3
  12. Trial status: Not Yet Recruiting to Recruiting Study sites: 2 to 51 · Primary completion date: Oct 2018 to Oct 5, 2018 · Completion date: Mar 2027 to Mar 5, 2027 · 1 morev2 Show 4 more changesShow less
    • Study sites: 2 to 51
    • Primary completion date: Oct 2018 to Oct 5, 2018
    • Completion date: Mar 2027 to Mar 5, 2027
    • Start date: Dec 2016 to Jan 5, 2017
  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.
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
Trial Details
NCT Number NCT03003299
Lead Sponsor Edwards Lifesciences
Conditions Aortic Stenosis, Aortic Stenosis, Severe
Enrollment 125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov