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ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System

Study acronym: ALT-FLOW II
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites reduced: 28 → 25 locationsv12
  2. Primary completion date: Jan 31, 2026 to Nov 1, 2026 Trial status: Recruiting to Active, Not Recruiting · Study sites: 33 to 28v11 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 33 to 28
  3. Study sites: 32 to 33v10
  4. Study sites: 30 to 32v9
  5. Study sites: 26 to 30v8
Show 6 earlier versionsHide 6 earlier versions
  1. Primary endpoints revised (2) Study sites: 23 to 26 · Completion date: Jul 31, 2030 to Aug 31, 2030 · Eligibility criteria expanded, about 36 words · 1 morev7 Show 4 more changesShow less
    • Study sites: 23 to 26
    • Completion date: Jul 31, 2030 to Aug 31, 2030
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints: details revised at 2 of 3 entries

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 22 to 23v6
  3. Primary completion date: Oct 31, 2024 to Jan 31, 2026 Study sites: 19 to 22 · Completion date: Oct 31, 2029 to Jul 31, 2030v5 Show 2 more changesShow less
    • Study sites: 19 to 22
    • Completion date: Oct 31, 2029 to Jul 31, 2030
  4. Study sites: 1 to 19 Eligibility criteria expanded, about 2 wordsv4 Show 1 more changeShow less
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Oct 31, 2025 to Oct 31, 2024 · Study sites: 0 to 1 · Completion date: Oct 31, 2030 to Oct 31, 2029 · 4 morev3 Show 7 more changesShow less
    • Primary completion date: Oct 31, 2025 to Oct 31, 2024
    • Study sites: 0 to 1
    • Completion date: Oct 31, 2030 to Oct 31, 2029
    • Start date changed from estimate of Mar 1, 2023 to Apr 1, 2023
    • Eligibility criteria expanded, about 55 words
    • Secondary endpoints expanded, about 50 words
    • Study description expanded, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  6. Lead sponsor: [Redacted] to Edwards Lifesciences Trial status: Withheld to Not Yet Recruiting · Primary completion date: Oct 31, 2025 · Completion date: Oct 31, 2030 · 2 morev2 Show 5 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary completion date: Oct 31, 2025
    • Completion date: Oct 31, 2030
    • Start date: Mar 1, 2023
    • Study title shortened, about 3 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.
This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.
Trial Details
NCT Number NCT05686317
Lead Sponsor Edwards Lifesciences
Conditions Heart Failure
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov