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Exploratory Study of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW Canada)

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Jan 1, 2019 to Jul 10, 2019 Primary completion date: Oct 27, 2023 to Nov 3, 2023 · Completion date: Dec 2028 to Nov 11, 2028v6 Show 2 more changesShow less
    • Primary completion date: Oct 27, 2023 to Nov 3, 2023
    • Completion date: Dec 2028 to Nov 11, 2028
  2. Re-verified, no change to tracked fieldsv5
  3. Primary completion date changed from estimate of Jan 2022 to Oct 27, 2023 Primary endpoint revised · Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 50 to confirmed 45 · 6 morev4 Show 9 more changesShow less
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 50 to confirmed 45
    • Completion date: Feb 2023 to Dec 2028
    • Interventions: Atrial Shunt (Device) to APTURE transcatheter shunt (Device)
    • Eligibility criteria shortened, about 396 words
    • Secondary endpoints: 5 to 8
    • Study sites revised (2)
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv3
  5. Lead sponsor: [Redacted] to Edwards Lifesciences Trial status: Withheld to Recruiting · Primary completion date: Jan 2022 · Completion date: Feb 2023 · 2 morev2 Show 5 more changesShow less
    • Trial status: Withheld to Recruiting
    • Primary completion date: Jan 2022
    • Completion date: Feb 2023
    • Start date: Jan 1, 2019
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Exploratory study of the Edwards APTURE transcatheter shunt system (APTURE system) is a multi-center, prospective, exploratory study to evaluate initial clinical safety, device functionality, and effectiveness of the APTURE system.
Trial Details
NCT Number NCT04000607
Lead Sponsor Edwards Lifesciences
Conditions Heart Failure
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov