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IMPACT EU Post-Market Clinical Follow-Up Study

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 30, 2025 (before its estimated August 8, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Jun 2025 to Aug 8, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 2026 to Aug 8, 2026
    • Site details revised at 13 of 13 sites
    v8
  2. Primary completion date: Aug 2024 to Jun 2025v7 Show 4 more changesShow less
    • Primary endpoints revised (3)
    • Study sites: 8 to 13
    • Study completion date: Aug 2025 to Jun 2026
    • Eligibility criteria revised
  3. Study sites: 6 to 8
    • Eligibility criteria shortened, about 16 words
    • Secondary endpoints: 10 to 11
    • Study description shortened, about 11 words
    v6
  4. Study sites: 5 to 6v5
  5. Study sites: 2 to 5v4
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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 15, 2023 to Apr 27, 2023
    • Site details revised at 2 of 2 sites
    v3
  2. Enrollment target: 116 to 123v2 Show 4 more changesShow less
    • Study sites: 0 to 2
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints revised (10)
    • Study description revised
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
Heart Disease
8,786 trials monitored
See 412 trials at risk
The purpose of this trial is to collect further data on the safety and on the effectiveness of the use of Impella 5.5® in high-risk cardiac surgery patients.
Trial Details
NCT Number NCT05756751
Lead Sponsor Abiomed Inc.
Conditions
(from sponsor)		 Left Ventricular Dysfunction
Related terms Ventricular Dysfunction, Left
Enrollment 123 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov