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Early Feasibility Study - Edwards APTURE Transcatheter Shunt System

Study acronym: ALT-FLOW US
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years 3 months later Dec 15, 2023 → Apr 2027
See other at-risk trials from Edwards Lifesciences

Record History

  1. Primary completion pushed from Dec 15, 2023 to Apr 2027 Enrollment reopened · Primary endpoints: details revised at 1 of 1 entry · Enrollment increased: 71 → 90 participants · 7 more Show 10 more changesShow less
    • Enrollment reopened
    • Primary endpoints: details revised at 1 of 1 entry
    • Enrollment increased: 71 → 90 participants
    • Trial sites expanded: 15 → 19 locations
    • Completion pushed from Nov 2028 to Apr 2032
    • Interventions modified
    • Eligibility criteria expanded, about 79 words
    • Secondary endpoints revised (8)
    • Publications: details revised at 1 of 1 entry
    • Study description shortened, about 1 word
  2. 2 versions Re-verified since Oct 23, 2024, no change to tracked fieldsv11-v12
  3. Primary endpoint revised Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 75 to confirmed 71 · Study sites: 17 to 15 · 5 morev10 Show 8 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 75 to confirmed 71
    • Study sites: 17 to 15
    • Primary completion date changed from estimate of Dec 2024 to Dec 15, 2023
    • Completion date: Dec 2026 to Nov 2028
    • Eligibility criteria shortened, about 585 words
    • Secondary endpoints revised (8)
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Dec 2022 to Dec 2024 Study sites: 15 to 17v9 Show 1 more changeShow less
    • Study sites: 15 to 17
  5. Enrollment target: 55 to 75 Study sites: 10 to 15 · Eligibility criteria expanded, about 40 words · Secondary endpoints: 5 to 8v8 Show 3 more changesShow less
    • Study sites: 10 to 15
    • Eligibility criteria expanded, about 40 words
    • Secondary endpoints: 5 to 8

    See this version in full on ClinicalTrials.gov ↗

Show 6 earlier versionsHide 6 earlier versions
  1. Primary completion date: Jul 2021 to Dec 2022 Enrollment target: 40 to 55 · Study sites: 9 to 10 · Completion date: Jul 2025 to Dec 2026 · 1 morev7 Show 4 more changesShow less
    • Enrollment target: 40 to 55
    • Study sites: 9 to 10
    • Completion date: Jul 2025 to Dec 2026
    • Eligibility criteria expanded, about 147 words

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv6
  3. Lead sponsor: [Redacted] to Edwards Lifesciences Trial status: Withheld to Recruiting · Primary completion date: Jul 2021 · Completion date: Jul 2025 · 2 morev5 Show 5 more changesShow less
    • Trial status: Withheld to Recruiting
    • Primary completion date: Jul 2021
    • Completion date: Jul 2025
    • Start date: Jul 31, 2018
    • Study title shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  4. 3 versions Re-verified since Jun 11, 2018, no change to tracked fieldsv2-v4
  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 purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards APTURE transcatheter shunt system.
Trial Details
NCT Number NCT03523416
Lead Sponsor Edwards Lifesciences
Conditions Heart Failure
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov