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A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)

StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Active, Not Recruiting
  2. 2 versions Re-verified since Sep 19, 2023, no change to tracked fieldsv8-v9
  3. Primary completion date: Jun 2018 to Feb 14, 2019 Completion date: Jul 2022 to Jan 2026v7 Show 1 more changeShow less
    • Completion date: Jul 2022 to Jan 2026
  4. Secondary endpoints: details revised at 1 of 2 entries Site details revised at 1 of 2 sitesv6 Show 1 more changeShow less
    • Site details revised at 1 of 2 sites
  5. Results first posted: Sep 24, 2020 Secondary endpoints revised (2) · Site details revised at 2 of 2 sitesv5 Show 2 more changesShow less
    • Secondary endpoints revised (2)
    • Site details revised at 2 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Phase: Phase 3 to Not applicable Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 30 to confirmed 38 · Site details revised at 2 of 2 sitesv3 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 30 to confirmed 38
    • Site details revised at 2 of 2 sites
  3. Trial status: Not Yet Recruiting to Recruiting Eligibility criteria shortened, about 208 words · Secondary endpoints: 14 to 2 · Study title revisedv2 Show 3 more changesShow less
    • Eligibility criteria shortened, about 208 words
    • Secondary endpoints: 14 to 2
    • Study title revised

    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model: 9600TFX) in the treatment of symptomatic severe aortic stenosis patients on chronic dialysis, who are determined by the heart team to be unable to undergo safe open surgical therapy and have the benefits of the study valve implantation. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Trial Details
NCT Number NCT02903420
Lead Sponsor Edwards Lifesciences
Conditions Aortic Stenosis
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov