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ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 2 months later Dec 2026 → Mar 2029
See other at-risk trials from Edwards Lifesciences

Record History

  1. Study sites: 36 to 37 Interventions: SAPIEN X4/X4S THV (Device) to SAPIEN X4/X4S THV (Device) · Eligibility criteria expanded, about 37 words · Secondary endpoints: details revised at 2 of 4 entries Show 3 more changesShow less
    • Interventions: SAPIEN X4/X4S THV (Device) to SAPIEN X4/X4S THV (Device)
    • Eligibility criteria expanded, about 37 words
    • Secondary endpoints: details revised at 2 of 4 entries
  2. Primary completion pushed from Dec 2026 to Mar 2029 Completion pushed from Feb 2036 to Dec 2039 · Study sites: 35 to 36 · Interventions: SAPIEN X4 THV (Device) to SAPIEN X4/X4S THV (Device)v16 Show 3 more changesShow less
    • Completion pushed from Feb 2036 to Dec 2039
    • Study sites: 35 to 36
    • Interventions: SAPIEN X4 THV (Device) to SAPIEN X4/X4S THV (Device)
  3. Primary completion date: Dec 2025 to Dec 2026 Completion date: Feb 2034 to Feb 2036 · Site details revised at 1 of 35 sitesv15 Show 2 more changesShow less
    • Completion date: Feb 2034 to Feb 2036
    • Site details revised at 1 of 35 sites
  4. Site details revised at 2 of 35 sitesv14
  5. Study sites: 34 to 35v13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 33 to 34v12
  2. Study sites: 32 to 33v11
  3. Study sites: 24 to 32v10
  4. Study sites: 21 to 24v9
  5. Study sites: 19 to 21v8
  6. Study sites: 18 to 19v7
  7. Study sites: 7 to 18 Start date changed from estimate of Dec 2023 to Nov 22, 2023v6 Show 1 more changeShow less
    • Start date changed from estimate of Dec 2023 to Nov 22, 2023
  8. Study sites: 5 to 7v5
  9. Trial status: Not Yet Recruiting to Recruiting Start date: Sep 2023 to Dec 2023 · Study sites: 0 to 5v4 Show 2 more changesShow less
    • Start date: Sep 2023 to Dec 2023
    • Study sites: 0 to 5
  10. Start date: Nov 2022 to Sep 2023 Enrollment target: 150 to 200 · Eligibility criteria expanded, about 7 words · Study arms: 1 to 2 · 1 morev3 Show 4 more changesShow less
    • Enrollment target: 150 to 200
    • Eligibility criteria expanded, about 7 words
    • Study arms: 1 to 2
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  11. Lead sponsor: [Redacted] to Edwards Lifesciences Trial status: Withheld to Not Yet Recruiting · Primary completion date: Dec 2025 · Completion date: Feb 2034 · 2 morev2 Show 5 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary completion date: Dec 2025
    • Completion date: Feb 2034
    • Start date: Nov 2022
    • Study title expanded, about 5 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 who are at high or greater risk with a failing aortic bioprosthetic valve.
Trial Details
NCT Number NCT05172973
Lead Sponsor Edwards Lifesciences
Conditions Aortic Valve Insufficiency, Aortic Valve Stenosis
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov