Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05172960 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 35 words Secondary endpoints: details revised at 1 of 3 entries · Site details revised at 11 of 65 sites Show 2 more changesShow less
    • Secondary endpoints: details revised at 1 of 3 entries
    • Site details revised at 11 of 65 sites
  2. Site details revised at 7 of 65 sitesv22
  3. Study sites revised (65)v21 See this version in full on ClinicalTrials.gov ↗
  4. Trial status changed: Active, Not Recruiting → Recruiting Site details revised at 65 of 65 sitesv20 Show 1 more changeShow less
    • Site details revised at 65 of 65 sites
  5. Primary completion pushed from Jul 22, 2025 to Jul 2027v19
Show 17 earlier versionsHide 17 earlier versions
  1. Enrollment target: 915 to 1234 Completion date: Dec 2034 to Jan 2037 · Interventions: SAPIEN X4 THV (Device) to SAPIEN X4 THV (Device), SAPIEN X4S (Device) · Study arms: 2 to 3v18 Show 3 more changesShow less
    • Completion date: Dec 2034 to Jan 2037
    • Interventions: SAPIEN X4 THV (Device) to SAPIEN X4 THV (Device), SAPIEN X4S (Device)
    • Study arms: 2 to 3
  2. Primary completion date changed from estimate of Jun 2025 to Jul 22, 2025v17
  3. Trial status: Recruiting to Active, Not Recruiting Site details revised at 65 of 65 sitesv16 Show 1 more changeShow less
    • Site details revised at 65 of 65 sites
  4. Study sites: 64 to 65v15
  5. Study sites: 61 to 64v14
  6. Study sites: 57 to 61v13
  7. Study sites: 52 to 57v12
  8. Study sites: 44 to 52v11
  9. Study sites: 40 to 44v10
  10. Study sites: 34 to 40v9
  11. Study sites: 28 to 34v8
  12. Study sites revised (28)v7 See this version in full on ClinicalTrials.gov ↗
  13. Trial status: Active, Not Recruiting to Recruiting Study sites: 21 to 28 · Primary completion date: Oct 2025 to Jun 2025 · Eligibility criteria expanded, about 9 wordsv6 Show 3 more changesShow less
    • Study sites: 21 to 28
    • Primary completion date: Oct 2025 to Jun 2025
    • Eligibility criteria expanded, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  14. Trial status: Recruiting to Active, Not Recruiting Site details revised at 21 of 21 sitesv5 Show 1 more changeShow less
    • Site details revised at 21 of 21 sites
  15. Study sites: 8 to 21 Start date changed from estimate of Aug 2022 to Jun 20, 2022v4 Show 1 more changeShow less
    • Start date changed from estimate of Aug 2022 to Jun 20, 2022
  16. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 8v3 Show 1 more changeShow less
    • Study sites: 0 to 8
  17. Lead sponsor: [Redacted] to Edwards Lifesciences Trial status: Withheld to Not Yet Recruiting · Primary completion date: Oct 2025 · Completion date: Dec 2034 · 2 morev2 Show 5 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary completion date: Oct 2025
    • Completion date: Dec 2034
    • Start date: Aug 2022
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  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.
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
Trial Details
NCT Number NCT05172960
Lead Sponsor Edwards Lifesciences
Conditions Aortic Stenosis, Severe
Enrollment 1,234 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov