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PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis

Study acronym: P3
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. 4 versions Re-verified since Nov 18, 2022, no change to tracked fieldsv35-v38
  2. Results first posted: Dec 2, 2021 Primary endpoint revised · Interventions: SAPIEN 3 THV (Device), Surgical aortic valve replacement (SAVR) (Procedure) to SAPIEN 3 THV (Device), SAVR (Procedure) · Eligibility criteria expanded, about 19 words · 2 morev34 Show 5 more changesShow less
    • Primary endpoint revised
    • Interventions: SAPIEN 3 THV (Device), Surgical aortic valve replacement (SAVR) (Procedure) to SAPIEN 3 THV (Device), SAVR (Procedure)
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints revised (5)
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date changed from estimate of Dec 2020 to Nov 16, 2020 Interventions: Surgical aortic valve replacement (SAVR) (Procedure), Transcatheter Aortic Valve Replacement (TAVR) (Device) to SAPIEN 3 THV (Device), Surgical aortic valve replacement (SAVR) (Procedure) · Eligibility criteria expanded, about 278 words · Secondary endpoints: 2 to 5 · 2 morev33 Show 5 more changesShow less
    • Interventions: Surgical aortic valve replacement (SAVR) (Procedure), Transcatheter Aortic Valve Replacement (TAVR) (Device) to SAPIEN 3 THV (Device), Surgical aortic valve replacement (SAVR) (Procedure)
    • Eligibility criteria expanded, about 278 words
    • Secondary endpoints: 2 to 5
    • Primary endpoint revised
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Jan 2020 to Dec 2020 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 1328 to confirmed 1000 · Study sites: 81 to 77 · 1 morev32 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1328 to confirmed 1000
    • Study sites: 81 to 77
    • Completion date: Mar 2027 to Dec 2029
  5. Study sites: 79 to 81v31
Show 29 earlier versionsHide 29 earlier versions
  1. Study sites: 78 to 79v30
  2. Re-verified, no change to tracked fieldsv29
  3. Site details revised at 3 of 78 sitesv28
  4. Study description revisedv27 See this version in full on ClinicalTrials.gov ↗
  5. Study sites: 77 to 78v26
  6. Primary completion date: Oct 2018 to Jan 2020 Study sites: 76 to 77v25 Show 1 more changeShow less
    • Study sites: 76 to 77
  7. Study sites: 74 to 76v24
  8. Study sites: 76 to 74 Study description expanded, about 1 wordv23 Show 1 more changeShow less
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  9. Study description expanded, about 31 words Site details revised at 14 of 76 sites · Eligibility criteria expanded, about 2 wordsv22 Show 2 more changesShow less
    • Site details revised at 14 of 76 sites
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  10. Site details revised at 2 of 76 sitesv21
  11. Site details revised at 1 of 76 sitesv20
  12. Site details revised at 76 of 76 sitesv19
  13. Start date: Apr 2016 to Mar 2016v18
  14. Site details revised at 5 of 76 sitesv17
  15. 3 versions Re-verified since Aug 17, 2017, no change to tracked fieldsv14-v16
  16. Phase: Phase 3 to Not applicable Study sites: 75 to 76v13 Show 1 more changeShow less
    • Study sites: 75 to 76
  17. Study sites: 72 to 75v12
  18. Study sites: 69 to 72v11
  19. Re-verified, no change to tracked fieldsv10
  20. Study sites: 65 to 69v9
  21. Site details revised at 5 of 65 sitesv8
  22. Re-verified, no change to tracked fieldsv7
  23. Study sites revised (65)v6 See this version in full on ClinicalTrials.gov ↗
  24. Site details revised at 1 of 65 sitesv5
  25. Enrollment target: 1228 to 1328 Study sites: 3 to 65 · Eligibility criteria shortened, about 654 words · Secondary endpoints: 5 to 2 · 1 morev4 Show 4 more changesShow less
    • Study sites: 3 to 65
    • Eligibility criteria shortened, about 654 words
    • Secondary endpoints: 5 to 2
    • Study title expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  26. Trial status: Not Yet Recruiting to Recruiting Site details revised at 3 of 3 sitesv3 Show 1 more changeShow less
    • Site details revised at 3 of 3 sites
  27. Study sites: 0 to 3v2
  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 establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
Trial Details
NCT Number NCT02675114
Lead Sponsor Edwards Lifesciences
Conditions Aortic Stenosis
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov