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The Smart Pump Study

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 24, 2022 (before its estimated December 31, 2022 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 45 to confirmed 35
    • Site details revised at 6 of 6 sites
    v12
  2. Primary and study completion dates: Jun 30, 2022 to Dec 31, 2022
    • Enrollment target: 35 to 45
    • Study sites: 5 to 6
    v11
  3. Re-verified, no change to tracked fieldsv10
  4. Site details revised at 1 of 5 sitesv9
  5. Study sites: 4 to 5v8
Show 6 earlier versionsHide 6 earlier versions
  1. Enrollment target: 15 to 35
    • Primary and study completion dates: Jan 31, 2022 to Jun 30, 2022
    • Study title shortened, about 1 word
    v7
  2. Start date: Nov 5, 2020 to Nov 2, 2020v6
  3. Primary and study completion dates: Apr 30, 2021 to Jan 31, 2022v5
  4. Site details revised at 1 of 4 sitesv4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 31, 2020 to Nov 5, 2020
    • Site details revised at 4 of 4 sites
    v3
  6. Study sites: 0 to 4v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Abiomed Inc.
13 trials monitored
See 1 trial at risk
To demonstrate that the Impella® Hemodynamic Platform (the "Study Device") is safe, and measurements obtained are as good as currently used methods. These measurements include how much pressure the heart is generating and how much blood your heart is pumping during the PCI.
Trial Details
NCT Number NCT04465201
Lead Sponsor Abiomed Inc.
Conditions
(from sponsor)		 Cardiac Output
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov